[ad_1]
Pfizer announced Thursday that its COVID vaccine booster could further protect individuals from “all currently known variants” of COVID-19 – including the highly transmissible Delta variant. The booster is currently being tested, the company said, and showed “encouraging clinical trial data in a small number of participants in our study.”
Pfizer said the first two doses patients received elicited “strong immune responses” against the Delta variant and that current studies focus on whether the booster will further increase that response.
Trial data showed that when given six months after the second dose, the Pfizer booster has a “consistent tolerability profile” and neutralizes an immune response. Pfizer and BioNTech plan to share their recall data with the Food and Drug Administration in August and file for emergency use authorization soon after, a spokesperson for Pfizer said.
While Pfizer believes the booster will be very effective against the COVID variants, the company said it is also developing an updated Pfizer-BioNtech COVID vaccine that will specifically target the Delta variant. MRNA for a new vaccine trial is already in the works, the company said, and clinical studies are expected to begin in August, pending approval.
“We have said, and continue to believe that it is likely, based on all of the data available to us to date, that a third dose may be required within six to 12 months of full vaccination.” , Pfizer said. “While protection against serious illness has remained high for the full six months, a decline in efficacy against symptomatic illnesses over time and the continued emergence of variants are expected. the third dose may be beneficial in maintaining the highest levels of protection. “
The Centers for Disease Control and the FDA, however, released a joint statement Thursday saying those who are fully vaccinated “do not need a booster just yet.”
“Fully vaccinated people are protected against serious illness and death, including against variants currently circulating in the country such as Delta,” the statement said. “People who are not vaccinated remain at risk. Virtually all hospitalizations and deaths related to COVID-19 are unvaccinated people. “
Federal agencies said they were engaged in a “rigorous, science-based process” to determine “if or when” a recall would be necessary.
“We are continuing to review all new data as it becomes available and will keep the public informed,” they said. “We are ready for booster doses if and when science shows they are needed.”
Dr Sara Oliver of the CDC said in June that Pfizer and Moderna are both working on boosters for their respective vaccines. The two companies, Oliver said, plan to release their study data before the end of September.
Oliver also said COVID vaccine boosters may only be necessary for certain populations, including residents of long-term care facilities, adults 65 years of age or older, healthcare workers and those with compromised immunity.
In June, the FDA’s Dr Doran Fink said the agency would not grant emergency use approval for booster injections “simply because data on safety and immunogenicity exist.”
“There would also need to be criteria to determine the need for a modified COVID-19 vaccine and the selection of antigens to be included in that vaccine. And we predict it would be an international effort involving multiple public health and regulatory authorities. “
Fink said the FDA would also seek an “immune bridge approach” to ensure vaccines have “expected effectiveness” and to “meet potential future needs.”
The FDA won’t approve additional vaccines without also having additional clinical data, Fink said, as is the case with the seasonal flu vaccine.
“We recognize that there is an interest in eventually moving to a paradigm where no clinical data is needed to support the authorization of modified vaccines,” said Fink. “We do not believe that our current understanding of COVID-19, immunology and protective mechanisms against vaccines is yet at a point where we can do so.”
Alexander Tin contributed to this report.
[ad_2]
Source link