Message of the Day: Disease
Global Virus Death Toll Hits 2 million, Associated Press, January 15, 2021
As the world in many ways holds its breath for the inauguration of Joe Biden and Kamala Harris as the president and vice-president of the US in five days, and after Donald Trump became the first president in US history to be impeached for the second time in the wake of the attack on the US capital on January 6, the world continues to grasp for breath on the issue that dominated 2020 and at this point threatens to consume 2021 as well.
Global coronavirus deaths passed two million today.
It took eight months to hit the one million mark. It’s taken half that time to double.
In fact, the toll is far higher due to under-reporting for numerous reasons.
And new variants that are more infectious have been appearing as well.
How much effective vaccine, from how many sources, is and will be available, to who and how fast, is unknown, with the impact of new variants also uncertain. Therefore, slowing down the catastrophe, much less the end of the pandemic, is not yet in clear sight.
And in any event, the pandemic on this level could have been prevented, still could be mitigated, and will only be effectively ended, by science-based, consistent and humane public policy with leadership creating and reflecting this and basic human decency in personal behavior.
Here are a number of reports from the US and around the world:
‘This is not a game’: Global virus death toll hits 2 million
By CHRIS SHERMAN, MARIA CHENG, JOHN LEICESTER and JOSHUA GOODMAN, Associated Press, January 15, 2021
MEXICO CITY (AP) — The global death toll from COVID-19 topped 2 million Friday, crossing the threshold amid a vaccine rollout so immense but so uneven that in some countries there is real hope of vanquishing the outbreak, while in other, less-developed parts of the world, it seems a far-off dream.
The numbing figure was reached just over a year after the coronavirus was first detected in the Chinese city of Wuhan. The number of dead, compiled by Johns Hopkins University, is about equal to the population of Brussels, Mecca, Minsk or Vienna. It is roughly equivalent to the Cleveland metropolitan area or the entire state of Nebraska.
“There’s been a terrible amount of death,” said Dr. Ashish Jha, a pandemic expert and dean of Brown University’s School of Public Health. At the same time, he said, “our scientific community has also done extraordinary work.”
In wealthy countries including the United States, Britain, Israel, Canada and Germany, millions of citizens have already been given some measure of protection with at least one dose of vaccine developed with revolutionary speed and quickly authorized for use.
But elsewhere, immunization drives have barely gotten off the ground. Many experts are predicting another year of loss and hardship in places like Iran, India, Mexico and Brazil, which together account for about a quarter of the world’s deaths.
“As a country, as a society, as citizens we haven’t understood,” lamented Israel Gomez, a Mexico City paramedic who spent months shuttling COVID-19 patients around by ambulance, desperately looking for vacant hospital beds. “We have not understood that this is not a game, that this really exists.”
Mexico, a country of 130 million people, has received just 500,000 doses of vaccine and has put barely half of those into the arms of health care workers.
That’s in sharp contrast to the situation for its wealthier northern neighbor. Despite early delays, hundreds of thousands of people are rolling up their sleeves every day in the United States, where the virus has killed about 390,000, by far the highest toll of any country.
All told, over 35 million doses of various COVID-19 vaccines have been administered around the world, according to the University of Oxford.
While vaccination drives in rich countries have been hamstrung by long lines, inadequate budgets and a patchwork of state and local approaches, the obstacles are far greater in poorer nations, which can have weak health systems, crumbling transportation networks, entrenched corruption and a lack of reliable electricity to keep vaccines cold enough.
Also, the majority of the world’s COVID-19 vaccine doses have already been snapped up by wealthy countries. COVAX, a U.N.-backed project to supply shots to developing parts of the world, has found itself short of vaccine, money and logistical help.
As a result, the World Health Organization’s chief scientist warned it is highly unlikely that herd immunity — which would require at least 70% of the globe to be vaccinated — will be achieved this year. As the disaster has demonstrated, it is not enough to snuff out the virus in a few places.
“Even if it happens in a couple of pockets, in a few countries, it’s not going to protect people across the world,” Dr. Soumya Swaminathan said this week.
Health experts fear, too, that if shots are not distributed widely and fast enough, it could give the virus time to mutate and defeat the vaccine — “my nightmare scenario,” as Jha put it.
U.N. Secretary General Antonio Guterres said the 2 million milestone “has been made worse by the absence of a global coordinated effort.” He added: “Science has succeeded, but solidarity has failed.”
Meanwhile, in Wuhan, where the scourge was discovered in late 2019, a global team of researchers led by WHO arrived Thursday on a politically sensitive mission to investigate the origins of the virus, which is believed to have spread to humans from wild animals.
The Chinese city of 11 million people is bustling again, with few signs it was once the epicenter of the catastrophe, locked down for 76 days, with over 3,800 dead.
“We are not fearful or worried as we were in the past,” said Qin Qiong, a noodle shop owner. “We now live a normal life. I take the subway every day to come to work in the shop. … Except for our customers, who have to wear masks, everything else is the same.”
It took eight months to hit 1 million dead but less than four months after that to reach the next million.
While the death toll is based on figures supplied by government agencies around the world, the real number of lives lost to is believed to be significantly higher, in part because of inadequate testing and the many fatalities inaccurately attributed to other causes, especially early in the outbreak.
“What was never on the horizon is that so many of the deaths would be in the richest countries in the world,” said Dr. Bharat Pankhania, an infectious diseases expert at Britain’s University of Exeter. “That the world’s richest countries would mismanage so badly is just shocking.”
In rich and poor countries alike, the crisis has devastated economies, thrown multitudes out of work and plunged many into poverty.
In Europe, where more than a quarter of the world’s deaths have taken place, strict lockdowns and curfews have been reimposed to beat back a resurgence of the virus, and a new variant that is believed to be more contagious is circulating in Britain and other countries, as well as the U.S.
Even in some of the wealthiest countries, the vaccination drives have been slower than expected. France, with the second-largest economy in Europe and more than 69,000 known virus deaths, will need years, not months, to vaccinate its 53 million adults unless it sharply speeds up its rollout, hampered by shortages, red tape and considerable suspicion of the vaccines.
Still, in places like Poissy, a blue-collar town west of Paris, the first shots of the Pfizer formula were met with relief and a sense that there is light at the end of the pandemic tunnel.
Full Coverage: Coronavirus pandemic
“We have been living inside for nearly a year. It’s not a life,” said Maurice Lachkar, a retired 78-year-old acupuncturist who was put on the priority list for vaccination because of his diabetes and his age. “If I catch the virus I am done.”
Maurice and his wife, Nicole, who also got vaccinated, said they might even allow themselves hugs with their two children and four grandchildren, whom they have seen from a socially safe distance only once or twice since the pandemic hit.
“It is going to be liberating,” he said.
Throughout the developing world, the images are strikingly similar: rows and rows of graves being dug, hospitals pushed to the limit and medical workers dying for lack of protective gear.
In Peru, which has the highest COVID-19 fatality rate in Latin America, hundreds of health care workers went on strike this week to demand better pay and working conditions in a country where 230 doctors have died of the disease. In Brazil, authorities in the Amazon rainforest’s biggest city planned to transfer hundreds of patients out because of a dwindling supply of oxygen tanks that has resulted in some people dying at home.
In Honduras, anesthesiologist Dr. Cesar Umaña is treating 25 patients in their homes by phone because hospitals lack the capacity and equipment.
“This is complete chaos,” he said.
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Cheng reported from Toronto, Leicester from Poissy, France, and Goodman from Miami. Associated Press writers Victoria Milko in Jakarta, Indonesia, and David Biller in Rio de Janeiro contributed to this report, along with AP video journalist Sam McNeil in Wuhan, China.
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Coronavirus digest: Global death toll tops 2 million
Deutsche Welle, Bonn, 15.01.2021
The deaths of over 2 million people can be traced back to COVID-19, according to the latest statistics. The number is equal to the population of Brussels, Vienna or Mecca. Follow DW for the latest.
German hospitals have been put under strain with the increase number of COVID-19 hospitalizations
The global death toll from COIVID-19 passed 2 million on Friday, according to figures from Johns Hopkins University. The milestone came even as vaccines are being rolled out around the world in an all-out campaign to stop the pandemic.
While the count is based on figures supplied by government agencies around the world, the real toll is believed to be significantly higher because of poor testing and many inaccurately recorded deaths, especially during the first months of the outbreak.
It took eight months to reach 1 million dead and less than four months after that to reach the next million.
“Behind this terrible number are names and faces — the smile that will now only be a memory, the seat forever empty at the dinner table, the room that echoes with the silence of a loved one,” said UN Secretary-General Antonio Guterres. He said the toll “has been made worse by the absence of a global coordinated effort.
“Science has succeeded, but solidarity has failed,” he added.
Here’s a roundup of the other major developments around the world.
Americas
In the United States, President-elect Joe Biden announced plans to ramp up the vaccination drive against COVID-19. The plans include efforts to open thousands of vaccination sites, deploy mobile clinics, and utilize retired doctors to administer the vaccine.
Biden, who is set to take office next week, wants 100 million Americans to receive vaccine doses within the first 100 days of the rollout.
“You have my word: we will manage the hell out of this operation. This is a time to set big goals and pursue them with courage and conviction because the health of the nation is literally at stake,” said Biden on Friday.
Biden also picked David Kessler, a former chief of the US Food and Drug Administration (FDA), as the chief science officer of the White House coronavirus response team.
Kessler is to take over at the helm of Operation Warp Speed, the program to accelerate the vaccine roll-out set up by the outgoing administration of Donald Trump, US media including Politico reported.
Amazonas state in northern Brazil has admitted it is running short of oxygen to help those hospitalized with COVID-19 to breathe as the country struggles with a new variant of the coronavirus.
Doctors in Manaus, a city of 2 million people were choosing which patients to treat, officials said, as overloaded hospitals waited for fresh supplies of oxygen cylinders.
The governor of Amazonas Wilson Lima has declared a statewide curfew between 7 p.m. and 6 a.m to curb a fresh surge in coronavirus cases, partly as a result of a new variant found in Brazil.
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Will vaccines work against the new Covid variants? Scientists race to find out
By Aisha Abdool Karim, Bhekisisa Centre for Health Journalism, Daily Maverick, Johannesburg, 15 January 2021
One year later and the novel coronavirus is still posing complex questions for researchers. The recent emergence of new Covid-19 variants across the world has left scientists searching for answers once again as they try to understand what these changes mean for the pandemic and vaccine roll-outs.
One year later and the new coronavirus is still posing new questions for researchers. (Photo: bbc.com/wikipedia)
As South Africa awaits the arrival of its first shipment of Covid-19 vaccines there are growing concerns about a new coronavirus variant — known as 501Y.V2 — circulating in the country and what the changes in the virus could mean for how the existing vaccines work.
The new variant, which was first identified in the Eastern Cape in August, appears to spread much faster than the original form of the virus. President Cyril Ramaphosa said this week, “This explains the fact that many more people have become infected in a far shorter space of time.”
The number of daily infections during South Africa’s second Covid wave has surpassed those recorded during the first wave. The highest number of daily infections during the first wave was 13,944 on 24 July last year compared to the latest highest number recorded of 21,980 on 8 January.
Although early research suggests that this new variant doesn’t cause more severe illness than the original form of the virus, it does put more pressure on the health system as the rapid rise in cases quickly fills hospitals, Ramaphosa said.
Here, we break down how SARS-CoV-2 has emerged and how it might impact South Africa’s vaccine rollout.
What makes South Africa’s new variant different?
Over time there are small changes that naturally occur in viruses, which are called mutations. These mutations occur when a virus is making copies of itself and small errors appear in its genetic code. Most of the changes that happen during this process don’t really impact how the virus works, but some can be significant.
This is what happened with SARS-CoV-2. As the virus continued to spread within communities around the world, mutations started popping up. The new coronavirus, however, tends to mutate at a much slower rate than other viruses, like for instance HIV, because it uses a method called proofreading when it replicates to reduce the number of errors that accumulate.
In December, a genomics team led by the KwaZulu-Natal Research Innovation and Sequencing Platform (KRISP) at the University of KwaZulu-Natal, announced that during routine sequencing of the country’s virus they had identified a new variant called 501Y.V2.
The coronavirus, like other viruses, is made up of a string of genetic code. Scientists, like those at KRISP, then try to unravel that code to better understand how the virus works through a process called sequencing. By regularly sequencing samples from Covid tests done in the country, scientists can paint a picture and track how the virus is spreading and evolving.
The new version of SARS-CoV-2 is now dominant in South Africa and is thought to be driving the second wave of the country’s pandemic, Health Minister Zweli Mkhize said in December.
A preprint of the KRISP team’s findings, which was published on medRxiv on 22 December, explains that there are over 20 mutations in the new variant that makes it different from the initial form of the virus.
One of the main mutations is called N501Y. It occurs in a part of the virus called the spike protein. The spike protein, which sits on the surface of the virus, is a defining part of SARS-CoV-2 because it allows the virus to attach itself to human cells.
The N501Y mutation causes changes to an area of the virus called the “receptor binding domain” (where the virus latches onto our cells). This change allows the spike protein on the virus to more easily attach onto a person’s cells so that the parts better fit together — almost like two puzzle pieces.
South Africa is not the only country where a new variant has been identified. New forms of SARS-CoV-2 have also been reported in the United Kingdom and Brazil.
Although the variant that was identified in South Africa is not related to the one detected in the UK — called B.1.1.7 — there are changes to parts of the binding site of the virus that are similar in both variants. This mutation is thought to increase the transmissibility of the virus, making it spread faster, which could explain why both variants have become dominant in their respective populations.
A December preprint from the Centre for the Mathematical Modelling of Infectious Diseases (CCMID) at the London School of Hygiene & Tropical Medicine estimates that the new variant, first identified in the UK, is 56% more transmissible than the initial virus circulating in the country. Another January preprint on medRxiv found that the new variant could be spreading between 40% and 75% faster than the original virus.
Preliminary modelling shared in a more recent preprint by the CCMID on 11 January, suggests similarly increased transmissibility of around 50% in the 501Y.V2 variant in South Africa. “We don’t yet know for sure how much more transmissible the 501Y.V2 variant is, but early indications are that it may be similar to what they are seeing with B.1.1.7 in the UK,” says Richard Lessells, who was part of the KRISP team that identified the 501.Y.V2 variant.
“The UK is able to do hundreds of thousands of sequences so they have more power in the data to then compare the variant against other variants,” he explains. “We’ve still only got about 300 sequences of the variant in South Africa. So to do that kind of analysis to estimate how much more transmissible is just a bit more complicated.”
Will vaccines work against the new variant?
A handful of Covid vaccine manufacturers have released results from their clinical trials and received emergency use approval in countries such as the United States, Israel and the UK. All of these jabs rely on getting our bodies to identify the spike protein on the surface of the coronavirus as a way of producing an immune response.
“What these variants are showing is that this spike gene seems to be one of the regions that’s most susceptible to these mutations,” explains Lessells. “That could potentially indicate that even if the vaccines work against the variants we have now, there is a chance that they may not work against further mutations. We, therefore, need to start thinking about developing vaccines that target areas of the virus that are less likely to mutate.”
One of the mutations — called E484K — in the variant identified in South Africa also occurs at the binding domain (where the virus latches onto our cells) and helps the virus to evade antibodies produced by the body’s immune system. This raises questions around whether current jabs will work to protect people from the 501Y.V2 variant as it opens up the possibility that the virus can continue to spread.
Scientists are currently investigating how all the new variants will impact the protection offered by vaccines. But in the meantime, a few researchers have studied how our bodies’ natural immune response fares against mutations in SARS-CoV-2.
One study shared in a December preprint on bioRxiv looked at whether antibodies from someone who had recovered from Covid-19 were able to kill the virus or stop it from growing in cells in a lab setting. The paper found that the antibodies generated by the original version of the coronavirus were not able to stop the virus from replicating if it had mutations like those in the variants identified in South Africa and the UK.
Another preprint from a team based in the US shared on bioRxiv in January had similar results. Since most antibodies target the binding site of the virus, the E484K mutation had the biggest impact on helping new variants with this mutation evade the neutralising effect of these antibodies. The E484K mutation’s presence in the variant identified in South Africa means that antibodies are likely to be less effective against the new variant and offer less protection, Lessells says.
The E484K mutation also appears in a new variant identified in Brazil. In January, a preprintfrom a team of Brazilian scientists found that the changing nature of the virus also led to re-infections — meaning that people infected in the previous wave with the circulating virus at the time were not prevented from getting infected with the new variant. These results echo the findings of other papers that document how this particular mutation helps the virus to escape antibodies.
The KRISP team is conducting research looking at how antibodies work against the 501Y.V2 variant in South Africa in a lab setting. The results are expected to be released within the next week.
But, because most of these studies have been conducted in labs, they offer a limited window into how variants of the virus will interact in real people and also whether vaccine-induced immunity could produce different results.
“The immune response to a vaccine is very different and it tends to be broader [than what’s being tested in labs],” explains Lessells. “It’s not just antibodies [which is what the lab studies are looking at], but T cells as well, so there are different arms of the immune response.”
Our immune systems use two ways to fight off foreign invaders, such as viruses.
The first method uses B cells, which produce proteins called antibodies. These antibodies are a specific response and are tailored towards a particular germ — in other words, the antibodies for each infectious agent, or pathogen, are different. The antibodies lock onto the invader which then makes it easier for your body to identify the virus, or other harmful pathogens, that need to be destroyed.
The second part of our bodies’ response involves T cells. There are helper T cells, also known as CD4 cells, which help the B cells make antibodies and also help our bodies to make killer cells. The killer cells destroy the cells in your body that have been infected.
“The hope is that because of that broader immune response in our bodies, these mutations that we’re seeing in the variant will not be enough to significantly reduce the efficacy of the vaccines. But the reality is, we just don’t know.”
What does this mean for South Africa’s vaccine rollout strategy?
South Africa recently announced its vaccine strategy aiming to immunise 67% of the population — the country’s current plan is aiming to immunise two-thirds of the population against SARS-CoV-2 in order to achieve herd immunity. Herd immunity is when enough people have developed an immune response — in the form of antibodies and killer cells — to fight off the virus so that there is a low risk of the virus continuing to spread within that community.
To gain access to enough jabs for a mass vaccination programme, the government says it’s procuring jabs in three ways.
It has joined the World Health Organisation’s COVAX initiative which aims to ensure equitable access to a Covid jab and will supply the country with enough doses for 10% of its population.
This week Ramaphosa announced that direct negotiations with several manufacturers were also underway — so far 20 million doses of various jabs have been secured (this number includes the jabs that will be provided by COVAX), with the bulk expected to arrive in the first half of the year.
South Africa is also part of the African Union vaccine initiative, which will procure doses for the continent in bulk — individual countries will then order from the pooled collection. On Wednesday, Ramaphosa announced that this initiative had secured 270 million doses of different vaccine candidates from Pfizer, AstraZeneca (through the Serum Institute of India) and Johnson & Johnson. The first 50 million shots are expected to arrive between April and June of this year.
Despite indications that antibodies may not have as great an effect on the new coronavirus variants, this doesn’t derail the planned vaccine programme, Barry Schoub, the chair of South Africa’s ministerial advisory committee on Covid vaccines says.
“It is a concern that less neutralisation of the variant has been shown in blood samples from people who have recovered. But remember this is what’s in the laboratory. The human biological system is a lot more complicated,” he says.
“It shouldn’t necessarily affect the vaccine strategy at the moment. Things are still being studied and it can change but from our current knowledge, vaccines still seem to be effective against the variant.”
But research in this area is still ongoing and it is too early to definitively say whether the existing Covid vaccine candidates will work against the new variants that have been identified so far.
Dan Barouch is the director of the Centre for Virology and Vaccine Research at Harvard University and also a professor of medicine at the university’s medical school. His team developed the Johnson & Johnson/Janssen Covid vaccine candidate (the jab’s results are expected later this month) and is one of the groups testing the vaccine’s efficacy against the new variants.
Barouch says if the vaccine turns out to be less efficacious in the new variants, the jabs will need to be updated with new sequences. For mRNA jabs (Pfizer and Moderna) and vector-based vaccines (AstraZeneca and Johnson & Johnson), this will probably only mean a minor change.
“It’s not starting from scratch, but it’s a new product that has to be manufactured. But if it took a year to make the first vaccines, it’s not going to take a year to update them, it’ll probably take a few months,” Barouch explains.
Given that the variants are not the only forms of the SARS-CoV-2 virus in circulation, people will still get the current vaccines that are available, he says. Then if at a later point there needs to be an update to the jab, there will be another wave of vaccinations.
“But let’s hope that’s not needed because that will mean there will be a substantial delay before we can control the pandemic. What’s really needed now is more vaccines being approved, more vaccines being deployed, and we need the vaccine rollout to go faster. That’s what we need to end the pandemic.”
Lessells concludes: “We’re building on the scientific data available to understand the significance of these mutations but that doesn’t mean we should slow down or change the strategy to get vaccines to South Africa as quickly as possible. In many ways, it makes it more urgent.” DM/MC
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Here’s the latest on COVID-19 vaccines
BY
These are the COVID-19 vaccine prospects that have made it to phase three trials and beyond.
Dr. Doreen Brown, 85, receives the first of two Pfizer-BioNTech COVID-19 vaccine jabs administered at Guy’s Hospital in London, Tuesday, Dec. 8, 2020. U.K. health authorities rolled out the
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PHOTOGRAPH BY VICTORIA JONES, AP
- U.S. President-elect Joseph R. Biden, Jr. announced his incoming administration’s proposal for a $1.9 trillion COVID-19 rescue plan, including $20 billion to mount a national vaccination program.
- Despite a previously stated strategy of holding back some vaccine doses to ensure people can get their second shot, the Trump Administration started releasing its reserve doses in December 2020, the Washington Post reports. That means the previous stockpile no longer exists—dashing the hopes of U.S. state and local officials for a quick increase in the available vaccine supply.
Jump to: Pfizer | Moderna | Oxford | Gamaleya | Bharat Biotech | Novavax | Johnson & Johnson | Vector Institute | CanSino Biologics | Sinopharm | Sinovac | Murdoch
COVID-19 vaccines have reached consumers in record time. Though the process can typically take 10 to 15 years, the U.S. Food and Drug Administration has granted emergency authorization to vaccines made by Pfizer and Moderna in less than a year. Before now, the fastest-ever vaccine—for mumps—took four years to develop in the 1960s.
Yet even after a vaccine is authorized or fully licensed, it faces potential roadblocks when it comes to scaling up production and distribution, which also includes deciding which populations should get it first—and at what cost.
The U.S. Centers for Disease Control and Prevention have recommended that health-care personnel and long-term care residents receive the first doses. The agency is also proposing that the next in line should be people age 75 or older, and frontline workers. But the ultimate rollout will depend on state decision-making. President-elect Joe Biden and other top U.S. officials have received their first doses in public to demonstrate their confidence in the vaccines. But CDC director Robert Redfield, vaccine developers, and the FDA have said it’s unlikely the vaccines will be widely available until the middle of 2021. (Here’s why determining who is “first in line” for the vaccine depends on your state.)
Several efforts are underway to help produce and distribute the vaccines more quickly, including the U.S. government’s Operation Warp Speed initiative, which has pledged $10 billion and aims to develop and deliver 300 million doses of a safe, effective coronavirus vaccine by January 2021. The World Health Organization is also coordinating global efforts to develop a vaccine, with an eye toward delivering two billion doses by the end of 2021.
More than 60 vaccines are still going through a three-stage clinical trial process that’s required before they are sent to regulatory agencies for approval. Given the urgent need, some vaccine developers have compressed the clinical process for SARS-CoV-2 by running trial phases simultaneously.
VACCINE CLINICAL TRIAL PROCESS
Vaccine prospects
The COVID-19 candidates, like all vaccines, essentially aim to instruct the immune system to mount a defense, which is sometimes stronger than what would be provided through natural infection and comes with fewer health consequences.
To do so, traditional vaccines use the whole coronavirus, but in a killed or weakened state. Others use only part of the virus—whether a protein or a fragment. Some transfer the instructions for coronavirus proteins into an unrelated virus that is unlikely or even incapable of causing disease. Finally, cutting-edge vaccines under development rely on deploying pieces of the coronavirus’s genetic material, enabling our cells to temporarily make coronavirus proteins needed to stimulate our immune systems. (Find out more about vaccines and how they work.)
TYPES OF VACCINES
Here’s a look at the prospects that have reached phase three and beyond—including a quick primer on how they work and where they stand.
Vaccine rollout and safety
On January 12, the Trump Administration had announced its plans to fully release the country’s available doses of the vaccine. Yet such a stockpile no longer exists, according to a January 15 report from the Washington Post. The Trump Administration began releasing these doses at the end of December 2020, which proved a grim realization for health officials throughout the U.S. who had pinned their hopes on a rapid influx of vaccine doses. The Trump Administration has also urged states to open up vaccinations to anyone over age 65, rather than only prioritizing frontline health-care workers and elderly people in nursing homes. According to a New York Times survey, at least 28 states and Washington, D.C., have heeded the call and are now vaccinating older people. Yet the jumble of differing vaccine priorities in each state has led to confusion and uncertainty amid the continued rollout.
On January 14, U.S. President-elect Joe Biden announced his incoming administration’s proposal for a $1.9-trillion COVID-19 rescue plan, which includes $20 billion to mount a national vaccination program. The proposal calls for launching community vaccination centers and deploying mobile vaccination units to hard-to-reach areas, as well as free vaccines for all people in the U.S. regardless of immigration status. Also, on January 15, the Biden transition team named pediatrician and former U.S. Food and Drug Administration head David Kessler to lead the U.S. plan to accelerate the development and rollout of vaccines for COVID-19.
As of January 15, the U.S. had administered more than 12 million doses of the two authorized vaccines made by Pfizer-BioNTech and Moderna and had distributed more than 31 million doses.
A CDC report released January 6 revealed that severe reactions to the Pfizer-BioNTech COVID-19 vaccine are rare, offering reassurances of safety as efforts for wide-spread vaccination continue to ramp up. However, in a January 15 press release, Norwegian officials urged caution in vaccination of people more than 80 years old or with serious underlying diseases. Out of 33,000 doses given so far in Norway, the country recorded 23 deaths in elderly patients with suspected ties to the COVID-19 vaccine. Autopsies of 13 of these individuals suggest that common side effects like fever and nausea likely led to the fatal outcomes.
Who: A Massachusetts-based biotech company, in collaboration with the National Institutes of Health.
What: A nucleic-acid vaccine that requires two doses, four weeks apart.
Latest news: On January 8, the U.K. approved the use of Moderna’s vaccine, making it the third vaccine available in the country.
Approval status: On December 18, the FDA granted emergency approval to Moderna’s COVID-19 vaccine, a day after an advisory panel decided 20-0, with one abstention, that the benefits of the vaccine outweigh the risks, such as the mild side effects reported in their clinical trial. The vaccine has also been approved in the European Union, Canada and Israel.
Distribution: Moderna has begun shipping the first 5.9 million doses. It is the second vaccine to receive emergency authorization in the U.S., joining Pfizer’s candidate, which was approved a week earlier.
On December 11, the Trump Administration purchased an additional 100 million doses of Moderna’s vaccine for a total of 200 million doses before the end of June 2021. Moderna expects to have 20 million doses ready to ship in the U.S. by the end of the year. The company also says it remains on track to deliver at least 500 million doses globally per year beginning in 2021, thanks in part to a deal it has struck with Swiss manufacturer Lonza that will allow it to manufacture up to a billion doses a year. The company said its vaccine can be safely stored on ice or in a normal refrigerator for 30 days.
Efficacy and safety: The FDA has also published an analysis of the phase three study of Moderna’s vaccine. It confirms the company’s claims that its candidate is 94.1-percent effective in preventing mild cases of COVID-19 and 100-percent effective at preventing severe cases after taking two doses.
Moderna announced on December 22 that it plans to test how well its vaccine works against the new variant of the virus that’s been found in the U.K.
Clinical trials status: Moderna announced on December 17 that it is launching clinical trials to evaluate the vaccine’s safety in children and people with cancer; it will also establish a “pregnancy registry” to track the vaccine’s safety in people who are pregnant.
The company started the third phase of its clinical trials in July. Preliminary findings from its phase one trials showed that healthy subjects—including elderly patients—produced coronavirus antibodies and a reaction from T cells, another part of the human immune response. Phase three is testing the vaccine in 30,000 U.S. participants. The company also announced plans to test the safety and efficacy of a booster shot that would be delivered a year after the first pair of vaccine doses, according to CNBC. The trial will likely begin in July 2021.
Who: A Chinese biopharmaceutical company, in collaboration with Brazilian research center Butantan.
What: An inactivated vaccine.
Latest news: On January 11, Indonesia’s food and drug agency gave emergency use authorization to Sinovac’s vaccine and began administering it two days later. News of the rollout follows the January 8 move by Indonesia’s highest Islamic body to give religious approval to CoronaVac. The country hadalready received a total of three million doses of the vaccine.
Approval status: Approved for limited use in China and Indonesia.
Efficacy and safety: Reports released in early January place CoronaVac’s efficacy below that of other authorized vaccines. A late-stage clinical trial in Indonesia found CoronaVac’s efficacy rate to be 65.3 percent. On January 7, Brazilian officials announced that an in-country trial of the vaccine pointed to an efficacy of 78 percent. However, results from the trial released on January 13 found that CoronaVac had an efficacy of 50.4 percent, slightly more than the 50-percent minimum recommended by the World Health Organization. The difference comes down to the earlier estimate’s exclusion of trial participants who got “very mild infections” but did not require clinical assistance.
On November 17, preliminary results from Sinovac’s early trials, published in The Lancet, reported that the vaccine was safe but produced only a moderate immune response, with lower levels of antibodies compared to those in patients who have recovered from COVID-19. Preliminary results in macaque monkeys, published in Science, revealed that the vaccine produced antibodies that neutralized 10 strains of SARS-CoV-2.
Clinical trials status: CoronaVac entered phase three trials in July, with plans to recruit nearly 9,000 healthcare professionals in Brazil, in addition to phase three trials in Indonesia. A planned trial in Bangladesh was delayed, after Bangladesh refused in October to co-finance a late-stage trial.
Who: The U.K. university, in collaboration with the biopharmaceutical company AstraZeneca.
What: A viral vector vaccine.
Latest news: On January 12, the European Medicines Agency announced plans to review the Oxford-AstraZeneca vaccine and could issue conditional marketing authorization by the end of the month. The announcement comes amid a particularly severe surge of cases as a new and likely more contagious variant called B.1.1.7 rampages through the region. Early data suggest that the vaccine will effectively protect against the new variant prevalent throughout the U.K., and officials say more information about effectiveness against another variant racing through South Africa should be available soon.
Approval status: Approved for use in the United Kingdom, Argentina, and India.
Efficacy and safety: On December 8, The Lancet published an interim analysis of four of Oxford’s phase three trials. It showed the vaccine is safe and 70.4-percent effective in preventing COVID-19 after two doses, and 64.1-percent effective after one standard dose. In a subgroup analysis of the vaccine’s U.K. trial, the study also confirmed Oxford’s November 23 claim that the vaccine was 90-percent effective when given as a half dose followed by a full dose one month later. While further research is needed to confirm those results, the study authors note that the use of a lower dose would allow for wider distribution of the vaccine.
On November 18, preliminary results from Oxford’s phase two trials published in The Lancet, showed that the vaccine produced strong immune responses across all adult age groups, including older adults who are more vulnerable to the disease. Early results also revealed that the vaccine had triggered a strong immune response—including increased antibodies and responses from T cells—with only minor side effects such as fatigue and headache.
Distribution: Project members say their candidate can be stored in normal refrigeration, and they plan to seek an “emergency use listing” from the World Health Organization, which would set up their candidate for distribution in lower income countries. Oxford and AstraZeneca expect to produce up to three billion doses of the vaccine in 2021.
On December 30, the U.K. announced changes to its vaccine delivery plan: With COVID-19 infections spreading rapidly, the country will now prioritize delivering the first dose of either vaccine to as many at-risk people as possible, based on data provided to and released by health regulators. It will do so by delaying administration of the second dose of the AstraZeneca-Oxford drug; originally intended to be administered a few weeks after the first dose, patients will instead receive the second dose within 12 weeks. A similar rule was issued for the Pfizer-BioNTech vaccine—its two doses were previously split over three weeks—but regulators didn’t provide similar data to back the new regimen. Overall, the U.K. still recommends that recipients receive two doses of either vaccine for maximum benefit. Rollout of the AstraZeneca-Oxford vaccine will begin on January 4. Argentina announced a similar approval the same day as the U.K.
Clinical trials status: On December 11, AstraZeneca and Russia’s Gamaleya Institute announced they will work together to study the possibility of combining Oxford’s vaccine with Gamaleya’s Sputnik vaccine. Since both use the same adenovirus, researchers will investigate whether a combination of the two will improve efficacy. Clinical trials are expected to begin by the end of the month.
The AstraZeneca-Oxford vaccine’s phase three trial aims to recruit up to 50,000 volunteers in Brazil, the U.K., the United States, and South Africa. On September 8, AstraZeneca paused the trials for a safety review due to an adverse reaction in one participant in the U.K., which the company described as a “routine action.” After an investigation by independent regulators, the trials resumed in the U.K., Brazil, South Africa, and India in September and resumed in the U.S. a month later.
Who: An Indian biotechnology company, in collaboration with the Indian Council of Medical Research and the National Institute of Virology.
What: An inactivated vaccine, which requires two doses that are administered 28 days apart.
Latest news: On January 12, Bharat Biotech announced that it had signed an agreement with Precisa Medicamentos, a Brazilian pharmaceutical company, to sell COVAXIN in Brazil. Indian authorities announced on January 3 that they had authorized Bharat Biotech’s vaccine for emergency use after “careful examination.” The biotechnology company has not yet published data from its ongoing phase three trials but said in a statement that the vaccine “has generated excellent safety data with robust immune responses.”
The country has the second-highest caseload in the world—only behind the U.S.—with more than 10 million people infected. As a result, the country is embarking on an ambitious plan to vaccinate 300 million frontline workers and vulnerable people by August 2021.
Approval status: Authorized for emergency use in India.
Efficacy and safety: Results posted online in September but not yet peer reviewed show that the vaccine produced antibodies in monkeys. Bharat Biotech Executive Director Sai Prasad also told Reuters in October that preliminary results from early vaccine trials found more than 90 percent of human participants developed antibodies.
Clinical trials status: On November 16, Bharat Biotech announced it has begun phase three trials involving 26,000 participants at more than 25 centers across India.
Who: China’s state-run pharmaceutical company, in collaboration with the Wuhan Institute of Biological Products.
What: Two inactivated SARS-CoV-2 vaccines.
Latest news: On January 13, Hungary’s government announced that it had reached a deal with Sinopharm to buy the company’s vaccine, following Hungary’s criticisms of the pace of the European Commission’s vaccine rollout.
On December 31, China approved one of Sinopharm’s vaccine candidates for use, a day after the company announced results of its phase three study showing the vaccine to be 79-percent effective in preventing COVID-19. The company did not provide any data backing up its claim. Authorities in the country have set a goal to vaccinate 50 million people by Lunar New Year in mid-February, despite the lack of evidence that their available vaccines are safe and effective. Chinese officials have said the vaccine will be free for Chinese citizens, and that they will prioritize immunizations for high-risk groups such as the elderly and people with underlying conditions.
Approval status: Bahrain and the United Arab Emirates have bothapproved one of Sinopharm’s vaccines for general use. China has also approved one of the company’s vaccines for general use and another for limited use.
Sinopharm filed for final regulatory approval from China in late November, two months after the New Yorker reported that hundreds of thousands of Chinese civilians have already been vaccinated under the government’s emergency-use approval. China began to innoculate medical workers and other high-risk groups with the Sinopharm trial vaccines in July, making it the first experimental vaccine available to civilians beyond clinical volunteers
Efficacy and safety: In its approval of the Sinopharm vaccine, the UAE said that an interim analysis of the phase three study showed the candidate is 86-percent effective in preventing COVID-19 with no serious safety concerns. UAE officials claimed the vaccine is 100-percent effective in preventing moderate and severe cases of the disease. However, no data has been released from the study to date.
Preliminary findings from two randomized trials, published in the Journal of the American Medical Association, have shown the vaccine can trigger an antibody response with no serious adverse effects. The study did not measure T cell-mediated immune responses. These results are significant, though, as they are the first published data from human clinical trials for a COVID-19 vaccine that uses a whole, inactivated virus.
Clinical trials status: Sinopharm launched its first phase three trial in July among 15,000 volunteers—aged 18 to 60, with no serious underlying conditions—in the UAE. The company selected the UAE because it has a diverse population made up of approximately 200 nationalities, making it an ideal testing ground. Sinopharm will also undertake phase three trials in locations such as Peru and Bahrain.
Who: A biotechnology company based in Gaithersburg, Maryland.
What: A protein vaccine that involves a nanoparticle carrier to better aid delivery and uptake by cells.The vaccine is administered in two doses, 21 days apart.
Latest news: On December 28, Novavax announced the launch of its phase three study in the U.S. and Mexico, which will evaluate the safety and efficacy of its vaccine in up to 30,000 adults. The announcement comes a month after Novavax said it had completed enrollment in its phase three trial in the U.K., and that it expects to have interim data available in the first quarter of 2021.
Approval status: Not approved for use.
Efficacy and safety: On September 2, a study of the company’s phase one trial published in the New England Journal of Medicine found that the vaccine was safe and produced coronavirus antibodies at a higher level than is seen among those who have recovered from COVID-19. It also stimulated T cells, another arm of the human immune response.
Clinical trials status: On September 24, Novavax announced the launch of its phase three trial in the United Kingdom, which will evaluate the vaccine in up to 10,000 people, both with and without underlying conditions. Up to 400 participants will also be vaccinated against the seasonal flu as part of a sub-study that will help determine whether it is safe to give patients both vaccines at the same time. Trials in the U.S. and Mexico are now underway after several delays because of difficulties scaling up manufacturing, Reuters reports.
Who: One of the world’s largest pharmaceutical companies, based in New York, in collaboration with German biotech company BioNTech.
What: A nucleic-acid vaccine that requires two doses taken 21 days apart.
Latest news: On January 15, Pfizer announced that it will temporarily scale back the number of vaccine doses being delivered to Europe. The company says the disruption is the result of modifications being made to increase production capacity, according to CNBC. The disruption is expected to impact dose delivery through early February.
Approval status: On December 2, the U.K. became the first Western countryto approve any COVID-19 vaccine when it authorized the Pfizer-BioNTech candidate—making the drug the first mRNA vaccine in history allowed for human use. The FDA granted emergency approval to this vaccine on December 11, a day after an advisory panel decided 17-4 that the benefits of the candidate outweigh the risks for anyone over the age of 16. The vaccine has also been granted emergency approval in Canada and conditional approval in the European Union.
Distribution: The first vaccinations in the U.S. were administered to health-care workers at a medical center in Queens, New York. The CDC has recommended that health-care personnel and long-term care residents receive the first doses, but the ultimate rollout will depend on state decision-making. The New York Times surveyed all 50 states to find out how many doses they expected by the end of the year; most Americans will likely have to wait until spring at the earliest to receive the shot. Pfizer and BioNTech have signed two nearly $2-billion contracts with the U.S. government to provide 200 million doses for free by July 31, 2021.
On December 17, the FDA said that extra doses found in vials of Pfizer’s COVID-19 vaccine can be used. Vials normally hold enough liquid for five shots, but after the company rolled out 6.4 million doses, pharmacists discovered that some vials contained enough for two extra shots. Being able to use them rather than discard them potentially expands the U.S. supply of the drug by 40 percent, Politico reports.
The British government said it would prioritize vaccinations for the most vulnerable populations, including nursing home residents, health-care workers, older adults, and those with underlying health conditions. For now, Pfizer and BioNTech have agreed to provide 40 million doses of the vaccine to the U.K. It will be delivered in stages throughout 2020 and 2021. The country expects to make several hundred thousand doses available by the end of this year.
Globally, Pfizer expects to be able to produce up to 50 million vaccine doses in 2020 and 1.3 billion doses by the end of 2021. However, questions have been raised over the vaccine’s storage, which requires ultra-cold freezers set at minus 70 degrees Celsius (minus 94 degrees Fahrenheit).
Efficacy and safety: The New England Journal of Medicine published the results of Pfizer’s phase three study, showing the vaccine was safe and 95-percent effective in protecting against COVID-19 in people 16 and older. The FDA has also published an analysis saying that the Pfizer vaccine is safe and offers strong protection against COVID-19 within 10 days of the first dose, regardless of the recipient’s race, weight, or age.
On December 15, a day after the U.S. launched its immunization campaign, a health-care worker in Alaska was hospitalized for a severe allergic reaction. According to the New York Times, the worker had no history of allergies, and the reaction subsided after she was treated with epinephrine. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNBC that some adverse reactions are expected when a vaccine is distributed to a wider population.
Regulators in the United Kingdom are also investigating two allergic reactions that occurred as the country began its mass inoculation campaign earlier this month to people over the age of 16. Both people had a history of serious allergies, and both have since recovered, the AP reports. As a precautionary measure, U.K. officials have warned people with a history of serious allergic reactions to wait to get Pfizer’s COVID-19 vaccine.
The company is also testing how well its vaccine works against the new variant of the virus that’s been found in the U.K.
Clinical trials status: On November 18, Pfizer and BioNTech announcedthe conclusion of their phase three trials. The companies stated that they’ve met their primary goals: The analysis found the candidate to be 95 percent effective in preventing mild cases of COVID-19—and 94 percent effective in adults over 65 years old—with no serious safety concerns. The trials launched in July, enrolling a diverse population in areas with significant SARS-CoV-2 transmission. Pfizer has expanded the trial to include 44,000 people across multiple countries. Preliminary results of phase one/two data showed the vaccine produces antibodies and T-cell responses specific to the SARS-CoV-2 protein.
Who: A Russian research institution, in partnership with the state-run Russian Direct Investment Fund.
What: A viral vector vaccine that uses two strains of adenovirus and requires a second injection after 21 days to boost the immune response.
Latest news: Paraguay’s health officials approved Gamaleya’s Sputnik V vaccine on January 15, according to Russia’s sovereign wealth fund, following Venezuela’s move to issue emergency use authorization for the vaccine on January 13.
On December 11, the Gamaleya Institute and biopharmaceutical company AstraZeneca announced they will work together to study the possibility of combining Sputnik V with with the candidate that AstraZeneca has developed with the University of Oxford. Since both candidates use the same adenovirus, researchers will investigate whether combining them will improve efficacy. Clinical trials are expected to begin by the end of the month.
Approval status: In August, Russia cleared the Sputnik V vaccine for widespread use and claimed it as the first registered COVID-19 vaccine on the market—before the vaccine’s phase three trials had begun and despite the lack of published evidence at the time. In late December, Belarus and Argentina granted approval and began vaccination campaigns with the Sputnik V vaccine Venezuela and Paraguay also have granted emergency authorization, and Bolivia is planning to kick off a vaccination program with Sputnik V in late January with an initial shipment of 2.6 million doses. Serbia also has received an initial 5,000 doses of the vaccine.
Efficacy and safety: On November 11—two days after Pfizer’s announcement of its interim results—Gamaleya reported that an interim analysis of its phase three trial found 92 percent efficacy of the Sputnik vaccine. The report was only based on 20 cases, however, which experts say is too few to be convincing. In September, a study of the institute’s phase one/two trials published in the Lancet showed the vaccine produced antibodies and a reaction from T cells.
On December 14, Gamaleya announced that final results from its phase three trials pointed to an efficacy of 91.4 percent, based on more than 22,000 trial participants. Reuters reports that Gamaleya intends to publish the results in an international medical journal.
Who: One of the world’s largest multinational corporations, based in New Jersey, specializing in healthcare and pharmaceutical products.
What: An vector vaccine.
Latest news: On January 13, the New England Journal of Medicinepublished the results of an 805-participant phase two trial of Johnson & Johnson’s vaccine, which found promising evidence that the vaccine is safe and effective. But production of the vaccine is lagging. While the company pledged 12 million doses by the end of February and 100 million by the end of June, the company is likely at least two months behind schedule, according to the New York Times. On November 15, Johnson & Johnson launched a second phase three trial to study the safety and efficacy of a two-dose regimen of its vaccine candidate in up to 30,000 volunteers worldwide. The study intends to assess whether a second dose of the vaccine will offer longer protection.
Approval status: Not approved for use.
Efficacy and safety: On October 12, Johnson & Johnson announced that it paused phase three trials for an independent safety review due to an unexplained illness in a participant. The company didn’t provide any details, in part to protect the patient’s privacy, but said that illnesses and accidents are expected in large clinical studies. What’s more, study pauses are routine for clinical trials and aren’t typically reported. On October 23, the company announced it would resume trials.
In July, a study published in Nature showed that the vaccine elicited neutralizing antibodies in monkeys and provided “complete or near-complete” protection with just one dose. The phase two results reported in the New England Journal of Medicine found that among participants who received a single dose, 90 percent had antibodies 29 days later, and all recipients did 57 days later. Participants who received a second dose saw increased antibody levels.
Clinical trials status: On September 23, Johnson & Johnson announced the launch of its phase three “ENSEMBLE” trial to evaluate the safety of the vaccine—and how well it works—among up to 60,000 adults from a variety of countries. The trial will include “significant representation” from older populations and those with underlying conditions that make them more susceptible to COVID-19. The company announced on December 17 that the trial is fully enrolled with 45,000 participants; it expects to have interim data available by the end of January.
Who: The largest child health research institute in Australia, in collaboration with the University of Melbourne.
What: For nearly a hundred years, the Bacillus Calmette-Guerin (BCG) vaccine has been used to prevent tuberculosis by exposing patients to a small dose of live bacteria. Evidence has emerged over the years that this vaccine may boost the immune system and help the body fight off other diseases as well.
Latest news: On November 10, a U.S. study published in the Journal of Clinical Investigation found that among 6,201 healthcare workers in Los Angeles, those who had previously received the BCG vaccine reported symptoms of COVID-19 less often than those who hadn’t, a finding that study authors say strengthens the case for further research. In October, the U.K. launched a study of the BCG vaccine that is part of the Australian-led trials. The study is seeking to recruit 1,000 frontline health-care workers to test the vaccine’s effectiveness against COVID-19.
Clinical trials status: In April, researchers from the Murdoch Children’s Research Institute began a series of randomized controlled trials that will test whether BCG might work on the coronavirus as well. They aim to recruit 10,000 healthcare workers in the study. In an April 2020 scientific brief, the World Health Organization found that there is no current evidence that the BCG vaccine protects people against infection with the coronavirus.
Approval status: Not approved for use.
Who: A Chinese biopharmaceutical company.
What: A viral vector vaccine.
Latest news: A Russian pharmaceutical company Petrovax announced that more than 90 percent of participants in Russian trials of Ad5-nCoV had high levels of antibodies, but few additional details are currently available. Indonesia has ordered 20 million doses of CanSino’s vaccine; Mexico signed an agreement to buy 35 million doses.
Approval status: Though the company was still technically in phase two of its trial, on June 25, CanSino became the first company to receive limited approval to use its vaccine in people. The Chinese government has approvedthe vaccine for military use only, for a period of one year.
Efficacy and safety: Preliminary results from phase two trials, published in The Lancet, have shown that the vaccine produces “significant immune responses in the majority of recipients after a single immunisation.” There were no serious adverse reactions documented.
Clinical trials status: On December 21, CanSino announced that it has recruited more than 20,000 participants for its phase three trials in Pakistan, Russia, Mexico, and Chile. On August 15, Russian biopharmaceutical company Petrovax announced it had launched the first phase three clinical trial of Ad5-nCoV.
What: A protein vaccine, namely it uses small fragments of viral antigens called peptides to produce an immune response.
Latest news: On January 13, Russian state news agency TASS reported that of the more than 2,000 volunteers who had received both doses of EpiVacCorona’s two-dose regimen, none reported adverse reactions from the vaccine. In November, Russia launched mass trials of its EpiVacCorona vaccine; the trials will inoculate 150 people over the age of 60 and 3,000 volunteers over the age of 18.
Approval status: On October 14, Russia granted regulatory approval to EpiVacCorona even though the vaccine candidate has not published any results and has not entered phase three of its clinical trials. It is the second vaccine candidate that Russia has approved for use despite a lack of published evidence about its safety and efficacy.
Editor’s note: This story was originally published on July 31. It is regularly updated as developments occur.