The Pfizer coronavirus vaccine scored a point in the field of public opinion with an announcement by the American Food & Drug Administration on Monday that it is fully approved.
Now, it is likely that many more people will sign up to get the jab, health experts say, in that they will have even more confidence in the safety of the vaccine.
“The first allegation that anti-vaxxers said in every conversation is that there is only Emergency Use Authorization (EUA) and therefore the vaccine was not safe enough,” said Dr. David Dvir, head of the Primary Care Division at Meuhedet Health Maintenance Organization and a member of the Advisory Committee for Corona Vaccines. “So, in the battle with anti-vaxxers, this approval is very important.”
The win, however, is likely to stem far beyond a group of extremist anti-vaxxers to as much as 80% of the unvaccinated public, according to some counts, who are not anti-vaccination but were simply hesitant or afraid.
According to a survey published by Prof. Michal Grinstein-Weiss, director of the Social Policy Institute (SPI) at Washington University, nearly 40% of Israelis who are not vaccinated did not want to do it because they thought that the vaccine was not safe even in the short term.
Some 40% said they did not believe the vaccine was effective. Another 46% said they did not feel they know enough about the long-term impact of the vaccine.
“The public can be very confident that this vaccine meets the high standards for safety, effectiveness and manufacturing quality the FDA requires of an approved product,” said acting FDA Commissioner Dr. Janet Woodcock following the approval. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today’s milestone puts us one step closer to altering the course of this pandemic.”
The approval is only for individuals over the age of 16. The vaccine will remain available under the EUA for people as young as 12. It also does not include approval for pregnant women or a third shot for immunosuppressed patients or anyone else.
The Pfizer vaccine was first given EUA for individuals over 16 on December 11, 2020. People 12 through 15 years of age were added on May 10.
“EUAs can be used by the FDA during public health emergencies to provide access to medical products that may be effective in preventing, diagnosing or treating a disease, provided that the FDA determines that the known and potential benefits of a product, when used to prevent, diagnose or treat the disease outweigh the known and potential risks of the product,” the FDA explained.
The main difference between the EUA and the full approval is really a matter of time and numbers. It in no way indicates that the EUA was loose or not meticulous. In fact, the full approval was built on preclinical and clinical data and information previously submitted for the EUA, as well as the FDA’s own analyses.
To grant the approval, the FDA said, it “reviewed updated data from the clinical trial which supported the EUA and included a longer duration of follow-up in a larger clinical trial population.”
The effectiveness of the vaccine was based on an evaluation of 20,000 individuals who received the vaccine and 20,000 who received a placebo. The safety was evaluated based on 22,000 people in each cohort.
This is notwithstanding the more than 12 million doses of the Pfizer vaccine that have been administered in Israel alone, “so we are aware that the vaccine is very safe and has very few side effects – most temporary,” said Dr. Daniel Landsberger, chief physician for Maccabi Health Services.
The majority of the clinical trial participants evaluated by the FDA were followed up for between four and six months.
Now that the vaccine is approved, there could be more legal justification to demand vaccination or testing, not only in private companies but also for government employees – especially in the US and Canada, but also in Israel.
For example, US Service members had a choice to refuse vaccination because it could not be mandated while still under EUA. That could change now that the vaccines are fully approved.
“One may use the approval for mandatory vaccination for certain professions, like healthcare workers,” Landsberger said.
Dvir suggested that with the approval, the Green Pass could be pushed in any public-facing or public-serving establishment. He said he already knows of one hospital that started requiring employees to either get vaccinated or take two PCR tests at their own expense each week.
“I think this will become widespread,” he said.
The FDA and Pfizer agreed to continue testing the vaccine, as “information is not yet available about potential long-term health outcomes,” the FDA said.
Moreover, Pfizer will further assess the risk of myocarditis and pericarditis after vaccination, as well as to conduct a “pregnancy registry study to evaluate pregnancy and infant outcomes after receipt” of the shot during pregnancy.
Dvir said he believes that the FDA will approve a third shot in the coming weeks. The US government has said it plans to make a booster available to more of the public as early as September.
The next question on the table, said Dvir, will be whether people who were infected with the virus in Israel will be asked to get a booster shot, too.
“In the [vaccine] committee we will discuss it and see if, according to the data, people who got sick are protected or if they need the booster,” he said. “I think this will be the next question we have to deal with.”