LONDON – A new U.K. study indicates the Pfizer Inc./Biontech SE COVID-19 vaccine is less effective against the India variant of the SARS-CoV-2 virus that was designated as of global concern by the World Health Organization (WHO) on May 10.
HONG KONG – In the midst of a COVID-19 crisis, India has waived the need for “well-established” foreign vaccines to undergo local trials. That could open doors for vaccines by Pfizer Inc., Johnson & Johnson and Moderna Inc.
HONG KONG – Following a wave of concern about the efficacy of two COVID-19 vaccine candidates developed by China National Pharmaceutical Group (Sinopharm), interim analysis of an ongoing phase III trial, published May 26 in the Journal of the American Medical Association, has shown that adults receiving at least one dose of either of the company’s two inactivated SARS-CoV-2 vaccines had significantly reduced the risk of symptomatic COVID-19.
Jam-packed with efforts to address COVID-19 variants and next-step booster shots, as well as safety concerns over vaccine co-administrations and the expansion of emergency use authorizations (EUAs) into younger populations, May was another busy pandemic-fighting month for the world, despite higher numbers of those vaccinated and declining death and hospitalization rates.
HONG KONG – In the midst of a COVID-19 crisis, India has waived the need for “well-established” foreign vaccines to undergo local trials. That could open doors for vaccines by Pfizer Inc., Johnson & Johnson and Moderna Inc.
HONG KONG – Following a wave of concern about the efficacy of two COVID-19 vaccine candidates developed by China National Pharmaceutical Group (Sinopharm), interim analysis of an ongoing phase III trial, published May 26 in the Journal of the American Medical Association, has shown that adults receiving at least one dose of either of the company’s two inactivated SARS-CoV-2 vaccines had significantly reduced the risk of symptomatic COVID-19.
With the global COVID-19 pandemic and variants raising expectations about the need for booster shots, more companies are jumping into the vaccine space. But unless those sponsors have been engaging “in an ongoing manner” with the U.S. FDA on developing the manufacturing process and clinical trial program for their vaccine candidates, their emergency use authorization (EUA) requests may be denied, according to a new FDA guidance on EUAs for COVID-19 vaccines.
As infections and deaths continue to surge in some countries so does the demand for unfettered access to the technologies behind COVID-19 vaccines and other medical products. In seeking that access, several countries are stressing the need to develop their own manufacturing capacity as they look beyond the current pandemic.
The May 25 appearance of Francis Collins, director of the U.S. National Institutes of Health, before a congressional committee revolved in large part around the Biden administration’s so-called ARPA-H proposal, but the administration’s proposal to waive intellectual property rights for vaccines was also on tap.
Two weeks after Pfizer Inc.-Biontech SE’s mRNA-based COVID-19 vaccine received emergency use authorization (EUA) for adolescents ages 12 to 15, the first in that age group, Moderna Inc.’s mRNA vaccine has hit the primary immunogenicity endpoint in its phase II/III study of participants ages 12 through 17.
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