Pfizer BioNTech Seek FDA Nod For Fourth COVID-19 Senior Dos

Pfizer and BioNTech announced Tuesday that they have filed an application to the US Food and Drug Administration for urgent use permission of an extra booster dose of their COVID-19 vaccine for adults 65 or older who have already received a booster dose of any of the authorised or approved vaccines. The inference is based on two Israeli data sets. As per the businesses, both data sets showed support that an extra mRNA booster enhances immunity and lowers the incidence of verified infections and severe sickness.

The Israeli Ministry of Health analysed data for more than 1.1 million people aged 60 and older and found a lower likelihood of infection and serious sickness following a second booster. The individuals had no previous exposure to COVID-19 and were therefore eligible for a subsequent booster. The data demonstrated that subjects who received an extra booster dose of the Pfizer-BioNTech COVID-19 jab administered at least four months after the initial booster (third) dose had rates of confirmed infections that were two times lower and rates of severe illness that were four times lower than those who received only one booster dose, according to a news release.

The second set of results comes from an ongoing study of healthcare employees aged 18 and up who have received three doses of Pfizer/Covid-19 BioNTech’s vaccine. A total of 154 people out of 700 received a booster dosage at least four months following their third treatment. The second booster raised neutralising antibody titers against Omicron eightfold and tenfold after one and two weeks, respectively, compared to five months after the first booster. According to the companies, the addition of the booster did not cause any new safety issues.

The studies have still not been subjected to peer review.

The firms cited further “developing facts” that could justify the necessity of an extra booster, which were not included in the EUA submission. These preliminary findings suggest that an extra booster dose of the Pfizer-BioNTech COVID-19 vaccine given at least four months after a preliminary booster intake could reestablish levels of antibodies to raise post-third dose titer levels, enhance protection against disease and serious infections in Israelis aged 60 and up, and have a similar safety profile to previous doses.

Pfizer and BioNTech’s proposals will be reviewed as quickly as possible using the comprehensive and science-based methodology, according to the FDA.

The Vaccines and Related Biological Products Advisory Committee, the agency’s independent vaccine advisers, will meet in April to have a clear dialogue about factors for 2022 booster vaccinations, including whether and when those boosters may well be required and which populations to target, based on available information and the latest science on circulating or emerging virus variants, according to the agency. The meeting is still to be scheduled.

Albert Bourla, Pfizer CEO, warned on Sunday that a fourth dosage of the COVID-19 vaccine is likely to be required. The protection one gets from the third is good enough, in fact, really good for hospitalizations and deaths not to happen, but it’s not very effective against infections, and it doesn’t last very long, says Bourla on CBS’s programme “Face the Nation.” He added that they are just going to submit those statistics to the FDA, then they will see what the experts outside of Pfizer have to say. Only select immunocompromised adults in the United States are eligible for three doses of the coronavirus vaccine and a booster dose.

People aged 5 and up can have 2 doses of the Pfizer/BioNTech coronavirus vaccine, and those aged 12 and up can get a booster five months after their second shot.