Pfizer develops booster strategy, officials say not yet needed

The companies behind one of the three novel coronavirus (COVID-19) vaccinations authorized for emergency use, Pfizer and BioNTech, met with health officials on Monday to discuss the need for a booster dose, shortly after releasing a statement that they are preparing to submit data to the U.S. Food and Drug Administration (FDA) in the near future.

Pfizer and BioNTech’s statement said the companies have seen encouraging data in the ongoing booster trial of a third dose of the current BNT162b2 vaccine. Initial data from the study demonstrate that a booster dose given six months after the second dose has a consistent tolerability profile, while eliciting high neutralization titers against the wild type and the Beta variant, which are five to 10 times higher than after two primary doses, they said. In addition, data from a recent paper published in the journal Nature demonstrate that immune sera obtained shortly after dose 2 of the primary two dose series of BNT162b2 have strong neutralization titers against the Delta variant (B.1.617.2 lineage) in laboratory tests.

The companies said they expect to publish more definitive data soon as well as in a peer-reviewed journal and plan to submit the data to the FDA, the European Medicines Agency (EMA), and other regulatory authorities in the coming weeks.

However, the FDA in a joint statement with the U.S. Centers for Disease Control and Prevention (CDC) said that those who have been fully vaccinated do not need a booster shot at this time. Additionally, the EMA said it is too early to determine whether more than the two required doses is necessary.

Regulatory authorities said understanding the variants and exploring the need for boosters remains a top priority, and will continue to review new data as it becomes available.  

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