As many lower and middle-income countries continue to scramble for COVID-19 vaccine doses, which are largely being manufactured in Europe and the U.S., their own regulatory rules may be getting in the way in some instances.
As talk increases of third doses of COVID-19 vaccine, a game-changing option is delivering them intranasally instead of intramuscularly. “It’s all about nasal carriage. It’s a better way to not carry the virus and not make others sick,” Bluewillow Biologics Inc. CEO Chad Costley told BioWorld. “The most important thing is that it’s safe.”
The quiet cancellation of an Aug. 24 meeting in which the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP) was supposed to discuss COVID-19 vaccine boosters is raising more questions about whether the Biden administration got ahead of the data with its Aug. 18 announcement that it planned to roll out mRNA booster shots to adults beginning next month.
Cadila Healthcare Ltd. (also known as Zydus Cadila) has received emergency use authorization (EUA) in India for Zycov-D, making it the world’s first plasmid DNA vaccine for COVID-19. Besides the adult population, the Drug Controller General of India’s nod has also given the South Asian country its first COVID-19 vaccine for adolescents ages 12 to 18.
The FDA has granted full approval to Pfizer Inc.’s COVID-19 vaccine in a move that is hoped will convince unvaccinated citizens that the shot is safe and effective. The mRNA vaccine, which will be branded as Comirnaty and was first developed by Germany’s Biontech SE, has been available since Dec. 11 last year under an emergency use authorization (EUA) and is the first to receive the FDA’s full endorsement.
Suzhou Abogen Biosciences Co. Ltd.’s $700 million series C fundraising provides tailwinds for the development of its messenger ribonucleic acid (mRNA) platform. The company plans to accelerate its COVID-19 mRNA vaccine clinical trial, develop other vaccine candidates and oncology programs.
The Biden administration’s rollout of a COVID-19 booster plan before the FDA has even approved a booster admittedly is a “judgment call,” U.S. health officials acknowledged Aug. 18. But rather than a judgment call, “the introduction of booster doses should be evidence-driven and targeted to the population groups in greatest need,” the World Health Organization advised in an interim statement issued a week before the White House COVID-19 Response Team’s announcement.
Plans for offering COVID-19 vaccine booster shots in the U.S. took a big step forward Aug. 18, as Health and Human Services (HHS) public health and medical experts laid out their intention to offer booster shots across the country for people 18 and older beginning the week of Sept. 20 and starting eight months after an individual's second dose.
The HHS Advisory Committee on Immunization Practices that had mixed opinions in June on the necessity of boosters will have a chance to consider new data when it meets again Aug. 24. Since that June adcom, COVID-19 infection rates have risen steadily and the FDA allowed for a third dose of the mRNA vaccines in certain adults with compromised immune systems.
Pfizer Inc.’s Ticovac has been approved by the FDA for immunizing those ages 1 year and older against tick-borne encephalitis, a disease that’s not endemic to the U.S. but increasingly is found in Europe and Asia. Ticovac, developed with a master seed virus, was first approved outside the U.S. 45 years ago. Before the FDA approval, the CDC had recommended that travelers on their way to high-risk areas be vaccinated in Europe though the process could take up to six months.
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