In what is hoped to be the beginning of the end of America’s COVID-19 pandemic, the U.S. Food and Drug Administration on Friday night authorized the first vaccine to prevent the disease.
The vaccine, developed by Pfizer and its German partner BioNTech, appears to be extremely safe and highly effective.
It was developed faster than any previously approved vaccine in the United States – not by compromising safety or accepting a mediocre vaccine as some feared – but by spending billions of taxpayer dollars and taking advantage of recent scientific advances.
The vaccine could start to be delivered into people’s arms as soon as Monday, if not earlier. About 2.9 million frontline health care workers and nursing home residents are expected to receive the vaccine in the first few days.
More vaccine will be rolled out in the weeks and months to come, with both of two front runners expected to deliver a combined 300 million doses of their vaccines by the middle of next year, enough to vaccinate nearly half the population of the U.S.
“Today is truly a historic event for humanity as a whole,” said Moncef Slaoui, an immunologist and retired pharmaceutical executive who helped lead the government’s vaccine development effort.
“Eleven months almost to the day after a pandemic virus sequence was identified and devastated lives and livelihoods across the globe, science, industry and government working together were able to discover develop and manufacture in a record time the first of a series of potent vaccines that undoubtedly will be pivotal to ridding us of this plague.”
The FDA’s emergency use authorization for the Pfizer/BioNTech vaccine BNT162b2 in people ages 16 and up comes as the nation’s COVID-19 death toll tops the number of Americans who died on the battlefield in World War II.
President Donald Trump, who announced the decision in a 3-minute video on Twitter, said he was extremely proud of his administration’s accomplishment in collaboration with scientists and the private sector.
“Today’s achievement is a reminder of America’s unlimited potential when we have the will and the courage to pursue ambitious goals,” he said.
Other members of the administration were equally enthusiastic.
“It is nothing short of a medical miracle to have FDA authorization of a vaccine for COVID-19 just over 11 months since the virus was made known to the world,” said Alex Azar, head of the department of Health and Human Services in an emailed statement.
Dr. Stephen Hahn, the FDA commissioner, called the authorization “a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world.”
Next week, a second candidate COVID-19 vaccine, developed by the Cambridge, Massachusetts-based Moderna, will go through the same review process and is expected to be swiftly cleared for use.
The FDA will stop short of fully approving either vaccine. The agency has received all the standard short-term safety and effectiveness data, but the vaccines have not been tested for the two years typical of an approved vaccine so it is not yet clear how long protection will last.
“With science guiding our decision-making … the vaccine’s known and potential benefits clearly outweigh its known and potential risks,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
Data from Pfizer’s trial of 44,000 people, half of whom received the active vaccine and half a placebo, found no major safety concerns. The vaccine was 95% effective across the board, with various groups predisposed to a severe case of COVID-19 – such as people over 70, those with certain medical conditions including diabetes and lung disease, and people who are Black and/or Hispanic – seeing nearly equal protection.
“No better demonstration could be made that we as humans hold our future in our hands,” Slaoui said. “We can destroy it or we can restore it … the choice is ours.”
Others were equally exuberant about the scientific achievement, but remain cautious about the future, particularly in the short-term, when vaccines won’t be widely available and the virus continues to sicken more than 200,000 Americans a day and kill several thousand.
“I think it’s remarkable,” said Dr. Paul Offit, a pediatric infectious disease expert and director of the Vaccine Education Center at Children’s Hospital of Philadelphia.
The virus was genetically sequenced for the first time in January. “I don’t think you would have found a scientist on this planet who would have predicted this 11 months ago,” he said.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases agreed that the speed of vaccine development was almost unbelievable.
“It would have been inconceivable to me a year or two or three ago to think we were going to be successful in that,” he said in an interview Friday with the editor of the Journal of the American Medical Association.
“Now it’s our challenge to convince people that it wasn’t rushed in a reckless way, that it was an expression of the extraordinary scientific advances made with vaccine platform technology and the investment that was made,” Fauci added.
Both China and Russia have been vaccinating their residents for several months with home-grown vaccines but they have not been fully vetted. Both countries began distribution before completing large-scale trials designed to confirm safety and determine effectiveness.
Although a committee meeting Saturday will make a final determination, the vaccine should first be available to frontline health care workers and nursing home residents.
As more vaccine is manufactured in late January or February, vaccination will likely be expanded to include first responders, home health care workers, teachers, grocery store clerks, other essential workers, people at high risk for a bad infection either because of age or health status, and those in prisons and homeless shelters, which have seen particularly devastating outbreaks of COVID-19.
Younger, healthier people in low-risk professions will likely get access to vaccination in April or May, depending on demand and how many vaccines receive FDA authorization.
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How RNA technology works in COVID-19 vaccine
The Pfizer/BioNTech vaccine, like the one developed by Moderna, depends on so-called messenger RNA technology never before used in an approved vaccine or drug.
The technology takes advantage of the natural function of mRNA, which acts as a go-between or messenger, ferrying a recipe from the DNA to make the proteins responsible for every one of the cell’s functions.
With the vaccines, the mRNA is encapsulated in tiny, protective balls of fat that keep the mRNA from being chewed up by enzymes.
Once injected, the fat ball delivers the mRNA into a cell, triggering production of a protein found on the surface of the virus that causes COVID-19.
The fat balls are very fragile, which is why the vaccines have to be stored at very cold temperatures. Once they disintegrate, the mRNA doesn’t hang around very long to cause safety concerns.
The Pfizer/BioNTech vaccine has to be kept at subzero temperatures, with dry ice or a special freezer until five days before use, while Moderna’s can be refrigerated for a week before use, and at room temperature for up to 12 hours.
Moderna and BioNTech, a biotech firm based in Mainz, Germany, both have been developing mRNA vaccines for the last decade, but had not passed early trials in people. The COVID-19 pandemic provided them the funding and scientific support to put their novel approach to work.
Moderna was able to design its vaccine in just over a month, after receiving the DNA code of the SARS-CoV-2 virus, which causes COVID-19, last January. BioNTech began developing its vaccine around the same time.
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Both vaccines underwent animal testing and trials in people, starting small and building to large-scale, recently completed trials.
In typical vaccine development, each of those steps would have proceeded in sequence, taking years. Instead, this time, many of the steps were done simultaneously, allowing the vaccines to complete development, testing and manufacturing in record time.
Nearly all the vaccines being developed in the United States target a protein on the surface of the SARS-CoV-2 virus, called the “spike” protein.
Researchers in the U.S. government, led by Barney Graham at NIAID, discovered the precise configuration of the protein, allowing vaccine developers to take aim at a highly effective target.
Although SARS-CoV-2 is likely to mutate over time, the virus cannot enter cells and inflict its damage without this spike protein, so the vaccines are expected to remain effective, perhaps with a few tweaks.
The vaccine’s side effects: A sore arm, body aches
In trials of 44,000 and 30,000 respectively, Pfizer/BioNTech and Moderna saw very few problems more serious than a couple of days of feeling lousy.
Four people in the Pfizer/BioNTech trial developed Bell’s Palsy, a neurological condition that leads to temporary drooping of one side of the face.
At least two people in Great Britain, where the vaccine was approved and distribution started on Tuesday, had a powerful allergic reaction.
Margaret Keenan, 90, is the first patient in the United Kingdom to receive the Pfizer/BioNtech COVID-19 vaccine at University Hospital, Coventry, administered by nurse May Parsons, at the start of the largest ever immunization program in the UK’s history. Dec. 8, 2020
Taking those concerns into account, the FDA authorization includes an aggressive, multi-pronged look for reactions as vaccines are rolled out to millions of Americans.
Most people also will notice they got the vaccine – either because they have a sore arm for a day or two, as with the flu shot, or because they endure an unpleasant day or two, with body aches, headache and fever, particularly after the second required dose.
Offit, the infectious disease expert, said he thinks people should view such events not as concerning side effects, but as a positive sign that their immune system is responding to the vaccine.
Most of these side effects last no more than 48 hours, but may be significant enough people should consider clearing their calendar for a day or two after being vaccinated, officials have said, and organizations with essential workers, like emergency rooms, should avoid vaccinating everyone at once.
The feds’ price tag: $4B for Pfizer, Moderna vaccines
The federal government has spent more than $4 billion on these two mRNA vaccines, compared to the overall cost of the crisis, which is expected to cost the United States $16 trillion, according to Harvard economists.
Pfizer and BioNTech decided to develop their vaccine without government support, though they did accept a nearly $2 billion promise from the government to buy 100 million doses of the vaccine – enough to vaccinate 50 million Americans.
This approach took away the risk companies face by developing a vaccine. In other epidemics, such as the Ebola crisis in West Africa in 2014 and 2015, the outbreak had ended by the time the first vaccine could be tested and authorized, making it difficult for manufacturers to recoup their development costs.
The U.S. government has been criticized in recent days for not rapidly exercising its option to buy another 100 million doses; Pfizer has said that it cannot produce a second 100 million until the second half of next year.
Moderna received $483 million to develop its vaccine, $472 million to test it in a large, late-stage trial, and $1.5 billion to produce 100 million doses. On Friday, Moderna agreed to provide another 100 million doses.
If the other two vaccines in late-stage trials, one from Johnson & Johnson and the other from AstraZeneca and Oxford University, prove successful early next year, there will be 400 million more doses. J&J’s may be a single-dose vaccine, which will enable its vaccine to go even further.
Two more government-backed vaccines under development – one by the startup Novavax and the other by Sanofi and GlaxoSmithKline, recently delayed – would add another 200 million doses later in the year if proven successful.
Because the government pre-purchased the vaccine, individuals will not need to pay for the shots. It will even provide syringes and alcohol swabs, so people shouldn’t have to pay anything out of pocket.
How much of US population needs to be vaccinated?
About 70% of the population needs to be vaccinated or recently recovered from COVID-19 to stop widespread transmission of the disease.
That is likely to happen in small areas or regions of the country long before the nation as a whole, and the infection can be reintroduced if it is still circulating in other parts of the world that cannot afford the vaccines or are slower to receive them.
One of the major lingering concerns about the vaccines is whether enough people will get the shot to disrupt transmission.
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Many people have expressed concern about the COVID-19 vaccines, in part because they were developed rapidly and because the mRNA technology is so new.
Black Americans and others of color often distrust government for historical reasons and because of ongoing negative experiences in the medical system.
Committed anti-vaxxers oppose all vaccination, fearing risks that are so far largely theoretical with the COVID-19 shots.
Who isn’t covered by this FDA authorization?
A subset of people should not be vaccinated.
The cases in the U.K. suggest that people who have had a severe allergic reaction in the past and must carry an EpiPen or the equivalent with them at all times, should avoid getting the shot – at least until more is known about their situation.
Others should talk to their health care provider if they have serious immune issues. The Pfizer trial did include some people with HIV, but the numbers were too small to draw firm conclusions about the safety of the vaccine for them.
Pregnant and nursing mothers were not included in the trials, so it’s not clear whether the vaccine would be advisable.
Officials with a committee of the U.S. Centers for Disease Control and Prevention recently said they thought that women who are nursing are likely to be able to be vaccinated because the vaccine probably doesn’t pass through mothers’ milk.
Future trials will focus on pregnant and nursing mothers.
The vaccine also was not authorized for children under 16. Although Pfizer has begun testing the vaccine in adolescents ages 12 to 15, it has not accumulated enough data in that age group for the FDA to consider authorizing the vaccine for them.
Because serious cases of COVID-19 are extremely rare in young children, the vaccine has to be particularly safe to justify its use.
Testing will expand into younger children early next year, Pfizer officials have said, once they confirm the appropriate dose to give them.
Offit, a pediatrician, said he hopes the vaccine will be authorized for younger teens early next year, and younger children in time for the 2021 school year.
US military, CDC set to help with vaccine distribution
If developing and manufacturing a vaccine was difficult, getting it into hundreds of millions of shoulders will be even more complicated.
Operation Warp Speed’s Chief Operating Officer, Gen. Gus Perna has been charged with distributing the vaccine.
“Every waking moment is about one purpose. It’s about saving American lives,” he said in a prepared statement Friday. “There is nothing else that has our focus except the delivery of safe and effective therapeutics and vaccines to the American people.”
Nearly 3 million doses of the vaccine will be prepositioned across the 50 states in the next few days, so they can be delivered as quickly as possible after a committee signs off Saturday on who should get the vaccine first.
The U.S. military is helping with distribution logistics, as is the CDC, state departments of public health across the country, and drug stores like CVS and Walgreens.
Getting a vaccine has been a huge undertaking. How all 50 states scramble to dole them out is the next massive challenge.
The sub-zero temperature requirements of the Pfizer/BioNTech vaccine means it likely will be distributed mainly to hospitals and major population centers, while Moderna’s, with less stringent requirements, likely will be directed to more rural areas.
The Pfizer/BioNTech vaccine is given in two doses, 21 days apart, while Moderna’s two doses are given 28 days apart.
The federal government has a network of computer systems designed to keep track of who has gotten which vaccine, so people will be notified to get their second dose at the right time, and with the same vaccine as the first. It should also allow people who get their first dose in one place or state to get the second dose somewhere else.
Although the first round of shots will be distributed at hospitals and in nursing homes, vaccination should eventually be available at doctor’s offices, drugstores, special clinics and even some grocery stores.
Authorization of a vaccine offers the public some much, needed hope, said Dr. Michael Mina, an assistant professor of epidemiology and immunology at the Harvard T. H. Chan School of Public Health.
Vaccines will be a key tool for ending this pandemic.
But Mina worries people will see a vaccine as the magic bullet that will solve everything, with no need to do anything else.
“Now is not the time time to step back and say we don’t need to worry,” Mina said.
Instead of waiting for months for the vaccine to be rolled out across the country to people of different age groups, professions and health status, he said Americans should be doing what they can today to stop the spread.
Public health measures like masks and distancing, and the rapid, inexpensive, at-home tests he has been advocating throughout the pandemic, could help protect the average American much faster, he said.
But that’s not what he’s heard from policy makers, including some governors, who have wondered aloud why they should bother to try any other measures, with vaccines on their way.
“Now is not the time to say the vaccine is here let’s not worry anymore,” Mina said, noting how many people are still getting sick and dying every day. “Now is the time, more than any time that there has been, to say we have to do everything in our power to figure out how to stop this virus today, and set ourselves up for the best success, so that as the vaccine continues to be rolled out, we can really give it its best chance to stop it.”
Dr. Jesse Goodman, formerly the FDA’s chief scientist, said it’s ironic that the vaccine, which required a tremendous investment in new technology, appears to be successful, while simple, low-cost measures like mask wearing, still haven’t been universally accepted.
“These wonderful high-tech things we can do are not enough,” he said.
In addition to basic public health measures and vaccines, the country needs to invest more in its public health infrastructure and develop broad spectrum antivirals that can help prevent a pandemic from gaining a foothold.
“After every big public health emergency, the ones I’ve seen in the last 30 years, I hope and I pray that we invest more, we learn more, we have the infrastructure to respond,” Goodman said. “We’ve made progress, but let’s start working on the next one, because this isn’t going to be the last one.”
Contributing. USA TODAY reporter Adrianna Rodriguez
Contact Karen Weintraub at [email protected]
Health and patient safety coverage at USA TODAY is made possible in part by a grant from the Masimo Foundation for Ethics, Innovation and Competition in Healthcare. The Masimo Foundation does not provide editorial input.
This article originally appeared on USA TODAY: COVID vaccine: FDA authorizes Pfizer vaccine, deems it safe, effective