The FDA declared the Pfizer BioNTech vaccine is safe and effective for coronavirus. According to a Food and Drug Administration review, the vaccine “met the prescribed success criteria” in a clinical study. Also, the report said that there are no specific safety concerns that can prevent the agency from issuing a green light. This means that approval for emergency use authorization is very likely to come out as early as this weekend.
On December 10, an outside panel of scientific advisers will review the FDA report. They will also look into the analysis prepared by Pfizer Inc. and its German partner BioNTech SE. If they agree with the FDA’s findings, expect the issuance of a EUA within the next few days.
Emergency Use Authorization
The 53-page downloadable document contains the latest data from both the FDA and the manufacturers. It extensively covers the Phase 3 clinical trials and will serve as the main source of information for the advisory group’s decision.
Independent reviews outside of the FDA started coming in with positive feedback. One such expert is Dr. William Moss, the executive director for the Johns Hopkins Bloomberg School of Public Health International Vaccine Access Center. He said that he thinks “we can be confident in the findings of this trial.” Moss noted the extensiveness of the study, and that the effective rate translates well across various ethnic, racial, and age groups. Dr. Greg Poland, director of the Mayo Clinic's Vaccine Research Group, agrees. Based on the report, he sees “absolutely no reason why this emergency use authorization would not be granted.”
Part of the FDA report includes its findings for the vaccine’s effectiveness. The vaccine requires two doses given 21 days apart to receive the full effect. However, the agency noted that the vaccine already showed effectiveness even after the first dose. Immediately after the first shot, the risk of coronavirus reduces by 50%. After the second dose, effectiveness shoots up to 95%.
FDA’s findings also confirmed that the vaccine reduces the risk of acquiring a severe form of COVID-19. This development helped assuage health officials who feared that the vaccine can only protect against the mild forms of the disease.
Pfizer BioNTech’s coronavirus vaccine is not without side effects. The FDA report said that side effects are common, especially among the younger set. They consist of fatigue, muscle pain, or joint pain. Participants also reported cases of headaches, chills, and fever. In addition, there were cases of severe “adverse reactions,” but these are mostly rare occurrences. And, they happened much less frequently in adults older than 55 years.
The side effects signify that the body is reacting to the vaccine. After all, a strong immune response is what immunologists hope for after an inoculation. Dr. Angela Rasmussen, a virologist at the Center for Global Health Science and Security, advises preparing for the shots.
She said that “It doesn’t mean the vaccine is making you sick, but you should be prepared for potentially not feeling great for a day or two after getting it.”
Questions for Future Reference
Vaccines usually undergo clinical trials for longer periods of time. For coronavirus vaccines, the process needed expediting given the current damage of the virus to people’s health and the economy. While this helps get quicker approval, some questions will need answering later on.
First, the vaccine’s effect on children, pregnant and breastfeeding women will need more studies. The same applies to people with compromised immune systems. Also, questions arose from the effectiveness period of the vaccine. How long does a vaccine remain effective in the human body? How often should people get vaccines? And finally, can vaccinate people still get the virus and transmit it to others? These are questions whose answers will have to wait a little while longer.
How Many Will Be Available This Year?
If the independent review will confirm that the Pfizer BioNTech vaccine is safe, expect an immediate rollout by the US government. Thanks to Operation Warp Speed, the US will receive a guaranteed 100 million doses from Pfizer BioNTech. The companies expect around 50 million doses available for this year, with another 1.3 billion in 2021.
However, it remains very unlikely the US will receive all 100 million within days of a EUA. HHS Secretary Alex Azar expects around 6 million doses of Pfizer’s vaccine to arrive this month. This is enough to complete vaccinations for 3 million people. According to earlier plans, Medical workers and the elderly will get priority over the vaccines as well. Government officials estimate that vaccinations for the entire American population will take place by the 2nd quarter of 2021.
Watch the CBS News report on the FDA’s confirmation that the Pfizer BioNTech vaccine is safe and effective:
Do you agree that the Pfizer BioNTech vaccine is safe and that it deserves a EUA? Will you trust it enough to get a vaccine within the next few months? Let us know what you think by leaving your comments below.