Why is Pfizer creating a covid-19 vaccine booster?

Pfizer and BioNTech announced that a booster shot of their covid-19 vaccine “may be needed within 6 to 12 months after full vaccination” based on the data to date. Hours after the announcement in a joint statement the CDC and FDA said that at this time a booster shot would not be necessary.

The drugmakers also informed that they were working on a vaccine that would target the full spike of the Delta variant of covid-19. Pending regulatory approval, the companies plan to begin clinical trials in August. The announcement comes as the Delta variant is on track to become the dominant variant in the US with covid-19 cases rising especially in pockets of low vaccination rates.

Why is Pfizer creating a Covid-19 vaccine booster?

Citing evidence gathered from real world data from the Israel Ministry of Health, Pfizer and BioNTech said the efficacy of their vaccine waned six months after an individual was fully vaccinated. However, the drugmakers point out that “efficacy in preventing serious illnesses remains high.”

The findings from Israel “are consistent with an ongoing analysis from the Companies’ Phase 3 study.” This has led the drugmakers to believe that the need for a third dose of their vaccine “may be beneficial to maintain the highest levels of protection.”

Despite their belief that a third dose would have “the potential to preserve the highest levels of protective efficacy against all currently known variants including Delta, the companies are remaining vigilant and are developing an updated version” of their vaccine. The new vaccine would target the full spike of the Delta variant. The company has already developed the first batch to begin trials once health regulators give the green light, perhaps by August.

CDC and FDA tell the drugmakers to hold their horses

Shortly after the drugmakers released their statement the Centers for Disease and Control and Prevention (CDC) and the Federal Drug Administration (FDA) put out a joint statement countering the idea that a booster might be necessary.

"Americans who have been fully vaccinated do not need a booster shot at this time," the statement read. Adding "FDA, CDC, and NIH (the National Institutes of Health) are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary.” In the statement the agencies said that it would be up to them to decide when a booster would be necessary and that they were prepared for that possibility.

The statement from the two federal agencies touted the US’ fortune to have highly effective vaccines against covid-19 that are easily accessible to those 12 and up. “People who are fully vaccinated are protected from severe disease and death, including from the variants currently circulating in the country such as Delta," the statement read.

The FDA and CDC cautioned those who haven’t been vaccinated yet, “virtually all COVID-19 hospitalizations and deaths are among those who are unvaccinated.” The FDA and CDC encourage people to get vaccinated as soon as possible for themselves and their communities.