The Pfizer-BioNTech COVID-19 vaccine is still extremely safe and worth using, according to a federal advisory committee that recommended its use in people over the age of 16.
The Advisory Committee on Immunization Practices (ACIP) reviewed data presented as part of the companies’ application for a full license for the vaccine.
The vaccine was approved for emergency use, and on August 23, the Food and Drug Administration granted it a biologics license application – the technical term for full approval – in people aged 16 and up. Its use in adolescents aged 12 to 15 will be restricted until more data is gathered. Based on two months of data, emergency use was granted to expedite the vaccine’s availability during a crisis. Six months’ worth is required for full approval.
The Pfizer-BioNTech vaccine does carry the risk of two potentially dangerous side effects: myocarditis (heart swelling) and allergic reactions. However, the data show that these side effects are mostly manageable, with allergic reactions mostly detected during the 30-minute waiting period after vaccination and the vast majority of those with myocarditis leaving the hospital within a day or two.
According to the data, the vaccine also prevented the majority of cases of severe disease and death and averted far more problems than it caused. For example, for every 1 million vaccinated boys aged 16-17, 73 will likely develop myocarditis, while approximately 1,540 hospitalizations from COVID-19 infections will be avoided.
And, according to experts from the Centers for Disease Control and Prevention, most cases of myocarditis following COVID-19 vaccinations have been mild, though it is too early to tell whether they will suffer any long-term consequences.
Several committee members expressed their support, saying they hoped the vaccine’s approval would make it more acceptable to people who have previously refused vaccinations. Dr. Kathleen Dooling of the CDC told the group that nearly one-third of people who haven’t been vaccinated said they’d be more likely to get vaccinated after full approval.
According to Dr. Oliver Brooks, chief medical officer of Watts HealthCare Corporation, a community health center in Los Angeles, who was attending his first ACIP meeting as a voting member, the data also confirms that the emergency authorization was appropriate.
In comparison to December 2020, when the ACIP first approved the Pfizer vaccine, there is now six months of post-vaccination data instead of two, as well as a large number of observational studies on how the vaccine performed in 680,000 people around the world. Following the vote, the committee debated whether to support third vaccine doses for people who had already received two doses of the Pfizer-BioNTech or Moderna vaccines.
The Biden Administration promised earlier this month that booster doses would be widely available beginning the week of Sept. 20 to anyone who had been vaccinated at least eight months before.
According to CDC data, it is not yet clear whether the recent increase in COVID-19 infections among those who have already been vaccinated is due to waning immunity or the highly contagious delta variant. Many hospitals in the South, where the outbreak is currently at its worst, are already offering booster doses to staff and some patients, according to Dr. Helen Talbot of Vanderbilt University in Nashville.
Those who get vaccinated without formal authorization or approval, however, are not eligible for federal government compensation if they are harmed by vaccination, according to a CDC official.
Oliver and the committee members agreed that vaccinating the unvaccinated, both here and abroad, is the most effective way to stop the spread of COVID-19. Future vaccination efforts should focus on preventing severe disease, hospitalization, and death rather than all infections, according to committee chair Dr. Grace Lee, a pediatrician at Stanford University School of Medicine and Lucile Packard Children’s Hospital in Stanford, California.
It’s too early to think about getting rid of COVID-19, Lee says, because so many people are still unvaccinated and getting infected around the world.
Members of the committee also expressed concern that, while senior citizens continue to be at the highest risk for severe COVID-19 infections, offering vaccines based on age will discriminate against people of color, who often have shorter lifespans than whites, and their periods of high risk start at younger ages.