LONDON – The EMA has changed its stance on booster doses of the Pfizer Inc./Biontech SE COVID-19 vaccine and said they “may now be considered” at least six months after the second dose for people ages 18 and over.
Now that Pfizer Inc.-Biontech SE has submitted initial phase II/III study data to the FDA bolstering the case for an emergency use authorization (EUA) for its COVID-19 vaccine to children ages 5 through 11 years, the competition, including Moderna Inc., Novavax Inc. and Sanofi SA, falls further behind.
LONDON – Self-amplifying RNA (saRNA) specialist Vaxequity Ltd. has sealed a commercialization deal with Astrazeneca plc after delivering safety data in a phase I/II trial of the technology in a COVID-19 vaccine.
Five days after an FDA advisory committee recommended a booster dose of Pfizer Inc.-Biontech SE’s COVID-19 vaccine, Comirnaty, for people 65 and older or those who are at high risk of a serious infection, the CDC’s Advisory Committee on Immunization Practices (ACIP) struggled Sept. 22 with what a U.S. booster program would look like if only one booster is available when three different COVID-19 vaccines are being used in the country.
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.
Continuing an upward trajectory, BioWorld’s Drug Developers Index (BDDI) has climbed more than 10% since the start of this year, following sharp drops at the end of March and May. Shares began to rebound in June and the index has shown a steady incline, similar with the Nasdaq Biotechnology Index, which is currently up 12%.
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.
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.
LONDON – Conflicting data from around the world on the extent to which the Delta variant of SARS-CoV-2 is reducing the effectiveness of vaccines is generating uncertainty over the need, or not, for booster programs.
