A few hours after the U.S. CDC Advisory Committee on Immunization Practices’ Nov. 2 recommendation to allow children ages 5 through 11 to be administered Pfizer Inc. and Biontech SE’s COVID-19 vaccine, Comirnaty (tozinameran), the agency’s director, Rochelle Walensky, endorsed the recommendation. The recommendation came as the World Health Organization (WHO) expanded the COVID-19 vaccines it recommends in the fight against the pandemic by endorsing Bharat Biotech International Ltd.’s Covaxin.
Although the need for COVID-19 boosters remains a tense debate among policymakers and scientific experts worldwide, the U.S. FDA is basing its Oct. 14-15 Vaccines and Related Biologics Products Advisory Committee meeting on the premise that vaccine boosters are needed.
LONDON – The World Health Organization (WHO) is recommending the widespread rollout of Glaxosmithkline plc’s Mosquirix (RTS,S), the first malaria vaccine, following real-world evidence it is safe and can be integrated into routine immunization programs and existing malaria control measures.
While much of the global pandemic response has focused on vaccines, the World Health Organization is now calling on drug manufacturers to ramp up their supply and donations of monoclonal antibodies used to treat COVID-19 infections.
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 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.
PERTH, Australia – As the Delta variant of SARS-CoV-2 sweeps across the globe, drugs like Roche Holding AG’s interleukin-6 receptor inhibitor Actemra (tocilizumab) are being used, often off-label, to treat serious cases of COVID-19. That usage, however, is resulting in serious drug shortages that may leave some without treatment options.
PERTH, Australia – As the Delta variant of SARS-CoV-2 sweeps across the globe, drugs like Roche Holding AG’s interleukin-6 receptor inhibitor Actemra (tocilizumab) are being used, often off-label, to treat serious cases of COVID-19. That usage, however, is resulting in serious drug shortages that may leave some without treatment options.
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.
Interim data for Soberana-02, a Cuban COVID-19 conjugate vaccine, surpassed the threshold set by the WHO, according to the Finlay Institute of Vaccines (IFV) in Havana that developed it, although the results have not been peer reviewed.
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