Pfizer, BioNTech to Pursue COVID-19 Booster Shot; CDC Updates School Guidance

Pfizer and BioNTech said they will seek approval from the FDA for a booster shot of its COVID-19 mRNA vaccine; however, the FDA and CDC said that a booster is not necessary at this time.

In addition, with the delta variant now the predominant strain in the United States and in some countries around the world, the companies said Thursday it will also start clinical trials in August of an updated version of its 2-shot vaccine. The companies noted recently published data showing that 2 doses are effective against the delta variant but said they want to remain “vigilant.” The first batch of the updated vaccine has already been produced in Germany.

They expect a third dose to be even more powerful, based on early data that has not yet been published or submitted to the FDA or other regulatory bodies. A booster shot given at least 6 months after the second dose produced antibodies 5 to 10 times greater than after 2 doses, protecting against the original strain of the virus and a more recent strain, beta.

But in various published reports, other infectious disease experts and scientists pushed back against the idea that a booster is necessary. A peer-reviewed study published late last month in the journal Nature suggested that immunity from mRNA vaccines may last for years.

Some questioned the companies’ motives, citing conflicting studies about the subject, while another pointed out that that large swaths of the rest of the world have yet to see widespread vaccination with any dose.

For instance, Africa just marked its worst week of the pandemic ever, the World Health Organization said Thursday; after the vaccine deliveries to the continent were nearly nonexistent in May and June, they have begun to pick up somewhat, the organization said in a statement.

In a joint statement released Thursday night after the companies’ announcement, federal agencies said they “are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary. This process takes into account laboratory data, clinical trial data, and cohort data – which can include data from specific pharmaceutical companies, but does not rely on those data exclusively.”

“Americans who have been fully vaccinated do not need a booster shot at this time,” said the CDC and FDA, also pointing out that nearly all COVID-19 hospitalizations and deaths currently are among individuals who are not vaccinated.

The Pfizer/BioNtech vaccine is authorized for individuals aged 12 and older. On Friday, the CDC announced new guidelines for schools for fall 2021. Noting that children younger than 12 are not eligible for COVID-19 vaccines yet, the guidelines emphasize a “layered” approach to protection against the virus, including continued mask-wearing for unvaccinated students and staff.

The CDC said returning to in-person schooling is a “priority” but that municipalities need to continue to monitor community transmission as well as local vaccine uptake.