Pfizer and its German partner BioNTech formally submitted their request Nov. 20 for emergency use authorization of a COVID-19 vaccine.
The companies claimed their data revealed the vaccine candidate is 95% effective and protects many older, high-risk patients from dying.
In addition to the FDA submission, the companies have already started “rolling” applications in Europe and the U.K.
The companies plan to globally produce 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021, according to a previous press release.
It could take the FDA up to four weeks to approve the request. Friday’s filing sets off a chain of events as the FDA and its independent advisers debate whether the immunizations are ready.
“Help is on the way,” Dr. Anthony Fauci, the top U.S. infectious disease expert said on the eve of Pfizer's announcement, adding that it's too early to abandon masks and other protective measures. “We need to actually double down on the public health measures as we're waiting for that help to come.”
If approved, the plan to distribute the two-dose vaccine will be left up to individual countries, although most agree that first responders and other at-risk health care workers should get the first injections. Medical experts say it could be several more months before the vaccine is widely available to the public.
An illustration picture shows vials with Covid-19 Vaccine stickers attached, with the logo of US pharmaceutical company Pfizer, on November 17, 2020. (Photo by JUSTIN TALLIS/AFP via Getty Images)
If there's an emergency green light, “that vaccine is still deemed investigational. It’s not approved yet,” Dr. Marion Gruber, chief of FDA’s vaccine office, told the National Academy of Medicine this week.
That means anyone offered an emergency vaccination must get a “fact sheet” describing potential benefits and risks before going through with the shot, she said.
There will be a lot of unknowns. For example, the 95% protection rate is based on people who developed symptoms and then were tested for the virus. Can the vaccinated get infected but have no symptoms, able to spread the virus? How long does protection last?
That’s why the 44,000-person study needs to keep running -- something difficult considering ethically, participants given dummy shots at some point must be offered real vaccine, complicating the search for answers.
Additionally at least for now, pregnant women won't qualify because they weren't studied. Pfizer only recently began testing the vaccine in children as young as 12.
In addition to the strategic challenge of widespread distribution, another hardship is storing the vaccine. Pfizer said the drug must be kept in extremely cold, sub-zero temperatures. The company designed temperature-controlled containers that will use dry ice. Each container also has a GPS device to track the location and temperature of all shipments.
Biotech company Moderna hopes to also get FDA approval soon of its own experimental vaccine. Company leaders said their vaccine was 94.5% effective.
Moderna is in the process of gathering more data before reaching out to the FDA for emergency use authorization.
Other companies, like Johnson & Johnson and AstraZeneca, are also working on a coronavirus vaccine.
A decision on Pfizer-BioNTech's vaccine won't affect other COVID-19 vaccine candidates in the pipeline, which will be judged separately.
Having a vaccine would be the first line of offense against the pandemic, which has crippled the world. According to Johns Hopkins University, the world has reported more than 56 million positive cases and 1.3 million deaths.
In the United States alone, more than 11 million people have tested positive for coronavirus and more 250,000 people have died.
This story was reported from Los Angeles. The Associated Press contributed to this report.