Pfizer (PFE) and BioNTech (BNTX) announced “encouraging data” from their ongoing trial of a third COVID-19 vaccine dose. A third dose may be beneficial to maintain highest levels of protection from the COVID-19. They plan to submit the data of the booster dose to the FDA, EMA and other regulatory authorities in the coming weeks.
The companies believe a third dose of their COVID-19 vaccine BNT162b2 has the potential to preserve the highest levels of protective efficacy against all currently tested variants including Delta. However, the companies are remaining vigilant and are developing an updated version of their COVID-19 vaccine that targets the full spike protein of the Delta variant.
The companies plan to start clinical trials in August of an updated version of their vaccine that would better protect against the Delta variant.
According to companies, initial data from study demonstrated 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 5 to 10 times higher than after two primary doses.
In addition, data from a recent Nature paper demonstrated that immune sera obtained shortly after dose 2 of the primary two dose series of the companies’ BNT162b2 have strong neutralization titers against the Delta variant in laboratory tests.
The companies anticipate that a third dose will boost those antibody titers even higher, similar to how the third dose performs for the Beta variant.
BioNTech said, as seen in real world data released from the Israel Ministry of Health, vaccine efficacy in preventing both infection and symptomatic disease has declined six months post-vaccination, although efficacy in preventing serious illnesses remains high.
In addition, during this period the Delta variant is becoming the dominate variant in Israel as well as many other countries. The findings are consistent with an ongoing analysis from the companies’ phase 3 study.
Therefore, the companies continue to believe that it is likely that a third dose may be needed within 6 to 12 months after full vaccination. A third dose may be beneficial to maintain highest levels of protection.
The Pfizer-BioNTech COVID19 vaccine is authorized for use under an Emergency Use Authorization for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years of age and older.
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