Pfizer Inc. (PFE) and BioNTech SE (BNTX) have submitted phase 1 data to the US Food and Drug Administration to support the evaluation of a third, or booster dose of their Covid-19 vaccine (BNT162b2) for future licensure, the drugmakers said in a statement on Monday.
The companies also said they will submit the data to the European Medicines Agency and other regulatory authorities in the coming weeks.
The drugmakers noted that the phase 1 data in individuals who received a third dose of their vaccine showed a favorable safety profile and robust immune responses.
According to the companies, the booster dose elicited significantly higher neutralizing antibody titers against the initial SARS-CoV-2 virus (wild-type), and the Beta and Delta variants, compared to the levels observed after the two-dose primary series.
A booster dose given within 6 to 12 months after the primary vaccination schedule may help maintain a high level of protection against the Covid-19, the companies said.
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Phase 3 results evaluating the third dose are expected shortly and will be submitted to the FDA, the EMA and other regulatory authorities worldwide. In the US, Pfizer and BioNTech plan to seek licensure of the third dose via a supplemental Biologics License Application in individuals 16 years of age and older, pending FDA approval of the primary BLA submitted in May 2021.
Last week, the US Food and Drug Administration authorized additional Covid-19 vaccine dose for individuals with weak immunity, who need extra protection from Covid-19. The drug regulator amended the emergency use authorizations or EUAs for both the Pfizer-BioNTech Covid-19 Vaccine and the Moderna Covid-19 Vaccine to allow the third dose.
The immunocompromised individuals include solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
According to the agency, other fully vaccinated individuals at present are adequately protected and do not need an additional vaccine dose.
The EUA for Pfizer-BioNTech Covid-19 Vaccine is currently for individuals ages 12 and older, and for Moderna Covid-19 Vaccine is for individuals ages 18 and older.
Both vaccines are administered as a series of two shots. The Pfizer-BioNTech Covid-19 Vaccine is administered three weeks apart, and the Moderna Covid-19 Vaccine is administered one month apart.
As per FDA’s amendment, individuals with weaker immunity system will be allowed for an additional, or third, dose to be administered at least 28 days following the two-dose regimen of the same vaccine.
