Pfizer, BioNTech seek authorisation for third dose of Covid-19 vaccine
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Pfizer and BioNTech are expected to provide more definitive data as well as a plan which they will submit to the FDA (Food and Drug Administration), the EMA (European Medicines Agency) and other regulatory authorities
Pfizer and BioNTech announced on Thursday that they are seeking regulatory authorisation for a third dose of their Covid-19 vaccine. This comes after initial data from an ongoing trial that showed a third dose pushed the levels of Covid-19 antibodies between five to 10 times higher against the original coronavirus strain and the Beta variant, that was found first in South Africa, as compared with the first two doses of the vaccine.
In the coming weeks, the companies are expected to provide more definitive data as well as a plan which they will submit to the FDA (Food and Drug Administration), the EMA (European Medicines Agency) and other regulatory authorities, according to AFP.
Additionally, the companies also expect the third dose to perform well against the highly transmissible Delta strain, which is rapidly spreading around the world.
Keeping this in mind, companies are developing a Delta-specific vaccine, the first batch of which is being developed in BioNTech's facility in Mainz, Germany. If regulatory approvals are obtained, clinical studies are anticipated to begin by August 2021.
Israel, meanwhile, has witnessed drops in the efficacy rates of the vaccine despite two doses. Considering this, companies are saying that a third dose would be needed within six to 12 months after full vaccination. A statement by the companies said that continued emergence of variants is expected. While the vaccines protected against severe disease, a decline in efficacy against symptomatic disease over time was observed.
The United States Centers for Disease Control and Prevention along with the FDA released a joint statement late on Thursday stating that authorities were considering "whether or when a booster might be necessary", as reported by the news site. They stated that fully vaccinated Americans would not need a booster dose for the time being.
