The U.S. Food and Drug Administration issued an Emergency Use Authorization for the COVID-19 vaccine produced by New York-based Pfizer and German-based BioNTech. This is the final regulatory hurdle.
This is the fastest-developed vaccine in history, but doctors said it is safe and the process of working toward EUA has been methodical.
Nearly one year after the SARS-CoV-2 virus, which causes COVID-19, was discovered in Wuhan, China, the light at the end of the tunnel for the pandemic appears to be closer.
It’s been a year full of deaths, illness, lockdowns and loneliness, impacting lives in all areas from social interactions to the way people die. And in its path, a trail of economic devastation caused hardships for people across the globe.
While it will be a slow path toward a return to “normal life,” a vaccine has been what many in the U.S. and around the world have been waiting for.
A panel of independent scientists recommended approving the COVID-19 vaccine on Thursday, marking one of the last steps before the EUA.
“The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” said FDA Commissioner Stephen M. Hahn said in a statement.
The FDA will hold a briefing on Saturday morning at 9 a.m. (ET). HHS and DOD will hold a briefing with Operation Warp Speed on Saturday morning at 11:30 a.m. (ET). NewsNation Now will stream the news conferences in this story.
Who gets it first?
The first vaccinations are expected to happen within 24 to 48 hours of FDA approval, according to Dr. Moncef Slaoui, the chief adviser for the U.S. government’s Operation Warp Speed program.
The first recipients will be health care workers and nursing home residents, according to plans laid out by each state.
Two doses administered three weeks apart are required for protection.
Under its contract with Pfizer, President Donald Trump’s administration committed to buying an initial 100 million doses. Since the vaccine requires two shots, the first batch will cover 50 million Americans.
The general public won’t see the vaccine until 2021.
“By the time you get to the middle or end of the second quarter, namely April, May, June, July, that the people in the general public will be able to get vaccinated,” Dr. Anthony Fauci, the nation’s leading public health expert told NewsNation in November.
Fauci said having the vaccine doesn’t mean people can let their guard down.
“That is really in our own hands and in our own power,” Fauci said. “So, universal masks, keeping distance, avoiding crowds in congregant settings, particularly indoor, doing things outdoor preferentially, washing your hands. They seem very simple, but those are things that prevent the surges that we’re seeing now.”
What we know about the Pfizer COVID-19 vaccine
The shots made by Pfizer and BioNTech were tested in tens of thousands of people. And while that study is not complete, early results suggest the vaccine is 95% effective at preventing mild to severe COVID-19 disease. The companies told regulators that of the first 170 infections detected in study volunteers, only eight were among people who’d received the actual vaccine and the rest had gotten a dummy shot.
The companies have reported no serious side effects, although vaccine recipients may experience temporary pain at the injection site and flu-like reactions immediately after vaccination.
Doctors in the U.K. did report two vaccine recipients — who both suffer from severe allergies — had allergic reactions to the vaccine. British regulators are now advising those with severe allergic reactions to avoid being vaccinated. It’s not yet clear what caused the reactions and experts here in the U.S. claim it should not be a cause for major concern.
Dr. Jim Baker, the former CEO of the National Food Allergy Foundation, told NewsNation the reactions to the UK vaccine are not well-defined.
“They were in people who had allergic reactions before, to many different things, but not to this vaccine. I think the really valuable thing the British could do is look at these two cases and see what the real cause was,” Dr. Baker said.
Still, experts caution that a vaccine cleared for emergency use is still experimental and the final testing must be completed.
What’s in the vaccine and how it works
The vaccine does not contain the live virus, but the mRNA, or messenger RNA, from the spike protein of SARS-CoV-2. The mRNA in the vaccine is detected by your immune system, which recognizes it doesn’t belong there and begins making an immune response to it.
“When it enters your cells, the cells read the mRNA of the protein which is expressed on the surface of the cell,” Dr. Richard Novak, head of infectious diseases at the University of Illinois said. “And then the immune system sees that and recognizes it doesn’t belong there and starts to make an immune response to it.”
As that response happens, it can cause inflammation, which in turn can cause some of the mild side effects reported during the vaccine trials, such as fever, headache, body aches and fatigue.
What we don’t know
Still to be determined is whether the Pfizer-BioNTech shots protect against people spreading the coronavirus without showing symptoms. Another question is how long protection lasts.
The vaccine also has been tested in only a small number of children, none younger than 12, and there’s no information on its effects in pregnant women.
Operation Warp Speed is the name of the federal program designed to get the vaccine from the manufacturer to the patient. A complex logistical process will crisscross the skies and roads of America.
The vaccines will be shipping from three of its U.S. manufacturing sites – Saint Louis, Missouri, Andover, Massachusetts, and Kalamazoo, Michigan. Pfizer’s Pleasant Prairie, Wisconsin and Puurs, Belgium sites are also being used. Vaccines are then being shipped to the “points of use” (POU) across America.
In late November, Reuters reported United Airlines began moving shipments of the Pfizer vaccine, on charter flights to ensure it can be quickly distributed once it is approved.
One challenge: the Pfizer vaccine must be kept at -94 degrees Fahrenheit for transport, which led last month to concerns about a dry ice shortage.
“We will utilize GPS-enabled thermal sensors with a control tower that will track the location and temperature of each vaccine shipment,” Pfizer said in a statement.
Once the vaccines arrive at the hospitals, nursing homes, pharmacies or other POU, there are three ways to store them:
- Ultra-low-temperature freezers, which can extend shelf life for up to six months.
- The thermal shipping containers can be used as temporary storage units by refilling with dry ice every five days for up to 30 days of storage.
- Refrigeration units that are commonly available in hospitals. The vaccine can be stored for five days at refrigerated 35.6 degrees to 46.6 degrees.
CVS signed a contract with the Centers for Disease Control and Prevention to distribute the vaccine at 10,000 of its locations.
By the end of 2021, Pfizer says it will be able to deliver 1.3 billion doses.
Across the globe
This vaccine has already been approved in Britain and Canada.
Margaret Keenan, who turns 91 next week, received the first vaccine in the Western world. The retired British shop clerk received the vaccination on Tuesday.
“I feel so privileged to be the first person vaccinated against COVID-19,” said Keenan, who wore a surgical mask and a blue Merry Christmas T-shirt decorated with a cartoon penguin wearing a Santa hat. “It’s the best early birthday present I could wish for because it means I can finally look forward to spending time with my family and friends in the New Year after being on my own for most of the year.”
Every country has different rules for determining when an experimental vaccine is safe and effective enough to use.
China and Russia have offered different vaccinations to their citizens ahead of late-stage testing.
Next up is U.S. drugmaker Moderna’s COVID-19 vaccine. Citing a 94.1% efficacy rate, the company filed an application with the FDA for an emergency use authorization in November. If approved, as it’s expected to be, the first Americans could be getting their shots on Dec. 21.
AstraZeneca is expected to run another global trial after producing a lower-than-expected efficacy rate of around 70%.
Emergency Use Authorization Letter
“The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world. Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization. The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide.”
FDA Commissioner Stephen M. Hahn, M.D.
“While not an FDA approval, today’s emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine holds the promise to alter the course of this pandemic in the United States. With science guiding our decision-making, the available safety and effectiveness data support the authorization of the Pfizer-BioNTech COVID-19 Vaccine because the vaccine’s known and potential benefits clearly outweigh its known and potential risks. The data provided by the sponsor have met the FDA’s expectations as conveyed in our June and October guidance documents. Efforts to speed vaccine development have not sacrificed scientific standards or the integrity of our vaccine evaluation process. The FDA’s review process also included public and independent review from members of the agency’s Vaccines and Related Biological Products Advisory Committee. Today’s achievement is ultimately a testament to the commitment of our career scientists and physicians, who worked tirelessly to thoroughly evaluate the data and information for this vaccine.”
Peter Marks, M.D., Ph.D., Director of the FDA’s Center for Biologics Evaluation and Research
“Pfizer’s purpose is breakthroughs that change patients’ lives, and in our 171-year history there has never been a more urgent need for a breakthrough than today with hundreds of thousands of people continuing to suffer from COVID-19. As a U.S. company, today’s news brings great pride and tremendous joy that Pfizer has risen to the challenge to develop a vaccine that has the potential to help bring an end to this devastating pandemic. We have worked tirelessly to make the impossible possible, steadfast in our belief that science will win.”
Albert Bourla, Chairman and Chief Executive Officer, Pfizer
“We founded BioNTech to develop new technologies and medicines that utilize the full potential of the immune system to fight serious diseases. Today we are another step closer to our vision. We believe that today’s Emergency Use Authorization, and the subsequent distribution of our vaccine that has demonstrated an efficacy rate of 95% and a favorable safety profile, will help to save lives across the United States and could accelerate a return to normality.”
Ugur Sahin, M.D., CEO and Co-founder of BioNTech
Department of Health and Human Services
“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. Because of President Trump’s strong leadership and unwavering support for Operation Warp Speed, we have millions of doses of this vaccine that are now being shipped to every corner of America, with administration to begin as soon as providers are ready. The triumph of Operation Warp Speed is a tribute to dedicated public servants across HHS and the Department of Defense, our partners in the private sector, and incredible American scientists. This vaccine, like any vaccine FDA potentially authorizes, has been through multiple stages of safety review, and it has shown extraordinary effectiveness in protecting people from the virus. Vaccines will help bring this pandemic to an end, which is all the more reason to double down on the public health measures we need to stay safe in the coming months. As Americans get vaccinated, we need to continue taking steps like washing our hands, social distancing, and wearing face coverings to protect ourselves, our loved ones, and our communities.”
Health and Human Services Secretary Alex Azar
Department of Defense
“The massive logistical planning our military has contributed to Operation Warp Speed gives me even more pride in the talent and dedication of our service members. They have been crucial in bringing a safe and effective vaccine to the American people and in restoring the health of our country.”
Acting Secretary of Defense Christopher C. Miller
President Donald Trump
Speaker Nancy Pelosi
Today’s Emergency Use Authorization of the Pfizer vaccine is a tribute to the tireless efforts of scientists and doctors who have worked around the clock to ensure that we have a vaccine that is effective and safe. Americans should have full confidence in this vaccine knowing that it has been reviewed and recommended by the independent experts of the FDA’s advisory panel.
Now, with tonight’s FDA authorization, we must ensure that the vaccine will be free and distributed in a fair and equitable manner to as many Americans as possible as soon as possible. We must accelerate its manufacture, including by invoking the Defense Production Act. With vaccine distribution being administered by the states, state and local funding is also central to our efforts to crush the coronavirus.
Until the vaccine is widely available, it is essential that we continue to embrace the testing, tracing, treatment, mask wearing and social distancing that are essential to preventing thousands of Americans from dying every day from the pandemic.”
Speaker of the U.S. House of Representatives Nancy Pelosi (D)
Patient Fact Sheet
The Associated Press and Reuters contributed to this report.
This is a developing story.