The FDA’s Vaccines and Related Biological Products Advisory Committee rejected an sBLA for a third, booster dose of the COVID-19 vaccine Comirnaty from Pfizer Inc.-Biontech SE for ages 16 and over, then unanimously approved a recommendation for those ages 65 and older along with individuals at high risk of severe COVID-19 to get the booster.
As members of the White House COVID-19 Response Team talk about COVID-19 boosters as if they are a fait accompli for Americans even before the FDA completes its evaluation of the data, the controversy continues to roil around the need for another vaccine dose.
The Biden administration’s haste to roll out an eight-month COVID-19 vaccine booster program next week is bumping up against the reality of the data and the regulatory process.
PERTH, Australia – Engeneic Ltd. has begun a phase I trial of its nanocellular COVID-19 vaccine, which in preclinical animal studies stimulated a broad antiviral response against mutant strains of the virus, including the virulent Delta strain sweeping across Australia.
Chinese companies are finding that their COVID-19 vaccines are effective as booster shots and against variants of the virus, as data from more studies emerge. Those who have received the third dose of Sinovac Biotech Ltd.’s COVID-19 vaccine, Coronavac, showed 2.5-fold higher neutralizing potency against the Delta variant, compared to COVID-19 convalescents and two-dose vaccinees.
Minhai Biotechnology Co. Ltd. has won approval from the NMPA for its 13-valent pneumococcal conjugate vaccine, which makes it the third company with such a vaccine to be greenlighted in China.
Given the ethics and feasibility of placebo-controlled COVID-19 vaccine trials, Access Consortium members are recognizing appropriately designed immunobridging studies as an acceptable approach for authorizing the vaccines, including those being developed to protect against SARS-CoV-2 variants.
LONDON – The U.K. government has accepted the recommendation of medical experts and will begin the rollout of COVID-19 boosters from next week, using mRNA vaccines only. That follows data from the U.K. Cov-Boost trial, looking at combinations of initial and booster doses. The results showed Pfizer Inc./Biontech SE’s and Moderna Inc.’s products generated the best immune responses, regardless of which vaccine was administered initially.
The Biden administration may have jumped ahead of the FDA review when it announced last month that it planned to roll out COVID-19 boosters by Sept. 20, but that’s not likely to happen when it comes to the timing of vaccines for young children.
Minhai Biotechnology Co. Ltd. has won approval from the NMPA for its 13-valent pneumococcal conjugate vaccine, which makes it the third company with such a vaccine to be greenlighted in China.
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