The good of the many versus the good of the individual is the age-old question that faced the FDA’s Vaccines and Related Products Advisory Committee (VRPAC) June 10 as it considered the risk-benefit issues of COVID-19 vaccines in children. Panelist Cody Meissner, director of pediatric infectious disease at Tufts Medical Center, said while he believes a vaccine is needed for children, he wants to know that the safety of the vaccine is greater than the risk of hospitalization for people younger than 18.
The European Commission unveiled its third alternative to providing global access to COVID-19 vaccines and treatments just ahead of the June 8 meeting of the World Trade Organization’s Council for Trade Related Aspects of Intellectual Property Rights and the start of the G7 summit.
Sinovac Biotech Ltd.'s inactivated COVID-19 vaccine, Coronavac, has been approved by Chinese regulators for emergency use in children aged between 3 and 17, the company’s CEO Yin Weidong told Chinese state media on June 4. Sinovac briefly unveiled phase I/II data in the age group back in April. Chinese state media, China Central Television, said it confirmed the news with an expert from China’s State Council, though an official announcement has yet to be made. Sinovac did not immediately respond to BioWorld’s query to confirm the news.
Stemirna Therapeutics Co. Ltd., which specializes in mRNA technology, said it raised nearly $200 million to speed up the clinical study of its COVID-19 vaccine candidate, SW-0123. It is in phase I study in China and preclinical data have been published in Nature.
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.
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.
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.
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