The highly-regarded Pfizer COVID-19 vaccine received clearance from a Food and Drug Administration advisory panel yesterday. The approval clears the last remaining hurdle before the FDA can issue an emergency use authorization. Once Pfizer receives the EUA, it can roll out the vaccines and start inoculating Americans. And maybe, the coronavirus pandemic that brought the world to its knees may be coming to an end.
During the deliberation, Thursday, the Vaccines and Related Biological Products Advisory Committee voted 17 to 4 to approve the Pfizer BioNTech candidate vaccine. A lone member of the committee abstained.
While the FDA isn’t bound to accept the committee’s recommendation, the FDA usually takes the offered advice. This time, if the FDA agrees with the panel’s recommendation, it paves the way for the US to undertake a massive operation to fight coronavirus.
The timing cannot be more critical. Within 2020, the virus already claimed 290,000 American lives this year and infected more than 15 million. Approval for emergency use can come as early as Friday, should the FDA choose to do so. However, getting full approval is a different story. It will require a more extensive study to determine long-term efficacy and effects.
The panel’s recommendations will likely cover only groups featured under the trials. This means that pregnant women, children under 16 years, and people with compromised immune systems will have to wait. Trials for these groups are underway, and Pfizer will have to analyze and submit the results. Reportedly, the panel voted to limit recipients of the vaccine to those 18 years old and above. The safety panel studies for 16-17-year-olds were thin.
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Pfizer BioNTech also warned about potential side effects. The FDA report issued earlier this week reported that side effects are common occurrences. Fatigue, muscle or joint pain, fever, chills, and headaches were among those listed as happening after the first dose. Experts say that these effects meant that the body is reacting to the vaccine.
The United Kingdom started its mass inoculations to its frontline workers and the elderly last December 08. The country governing agency, the Medicines and Healthcare Products Regulatory Agency (MHRA) approved the vaccine last week. This week, they rolled one of the largest drives in non-war situations.
Initial feedback reported two incidences of anaphylaxis and a possible allergic reaction. MHRA Chief Executive June Raine issued a statement saying that “Any person with a history of anaphylaxis to a vaccine, medicine or food should not receive the Pfizer BioNTech vaccine.” She clarified that the vaccine met the MHRA’s standards, and the benefits still outweigh the risks.
Similarly, the FDA advisory panel considered the benefits. Panel member Eric Rubin, a microbiologist and editor in chief of the New England Journal of Medicine, said the “efficacy is overwhelming.” Another panel member and Precision Vaccines Program director, for Boston Children’s Hospital Ofer Levy, said it was an obvious yes vote. “When you have 2,000 to 3,000 people a day—a day—dying of coronavirus, to me this was a clear choice,” he said.
On the other side, panel members wanted more data before saying yes. Archana Chatterjee, dean of the Chicago Medical School at Rosalind Franklin University, gave a “No” vote because she found the data lacking. “My concern was that the data was very limited in the 16,17-year-olds,” she noted. Oveta Fuller, the virologist at the University of Michigan Medical School, also said no. She prefers to receive two more months of trial results.
The FDA’s division of vaccines said that even if the Pfizer COVID-19 vaccine gets a EUA, further evaluation is necessary. More studies will confirm if the benefits continue to outweigh the risks, or if the vaccine will need changes to its labeling. Apart from data for 16 and 17 years old, future trials should include studies on younger children, pregnant women, and immunocompromised people. So far, the FDA does not have evidence that a COVID-19 vaccine benefits children. School reopenings will depend on answers to that question.
Meanwhile, deputy clinical director Dr. Doran Fink recommended that the subjects during the trial who received placebos should continue doing so. This can help evaluate the effects on a longer period. Replacing placebos with actual vaccines from the subjects might limit the data gathered about the vaccine’s safety.
Watch the CNBC News video reporting that the FDA panel is recommending emergency use approval for Pfizer’s Covid-19 vaccine:
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With the Pfizer COVID-19 vaccine in the last stages of emergency approval, do you see the pandemic finally ending? Do you think vaccination will eliminate coronavirus once and for all? Or do you think more steps are needed to finally rid ourselves of the virus? Let us know what you think by sharing your opinion in the comment section below.