“Authorizing an additional COVID-19 vaccine expands the available vaccine options for the prevention of COVID-19, including the most severe outcomes that can occur such as hospitalization and death,” said FDA Commissioner Robert M. Califf, M.D.
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Multiple Chinese cities are adopting fresh COVID-19 curbs, from business halts to lockdowns, to rein in new infections, with the commercial hub of Shanghai bracing for another mass testing effort after finding a highly-transmissible Omicron subvariant.
The agreement will enable the sharing of scientific expertise, technical skills and materials with the U.S. National Institutes of Health (NIH) to help Afrigen produce mRNA vaccines against COVID-19 and other diseases, said the Cape Town-based biotech start-up.
With just a very small amount of raw sewage and a new analysis technique, researchers can determine the genetic mixture of SARS-CoV-2 variants in the community and detect new variants up to 14 days before they start showing up on patients’ nasal swabs, according to a new report; A sizable proportion of older patients may be taking medications that interact with Paxlovid, Pfizer Inc’s antiviral treatment for COVID-19, according to a new report.
The agency revised its EUA to authorize state-licensed pharmacists to prescribe Paxlovid to eligible patients, with certain limitations to ensure appropriate patient assessment and prescribing of Paxlovid.
Late-stage data on an experimental COVID-19 vaccine from Sanofi and GSK has showed the shot confers protection against the Omicron variant of the virus, the companies said. The so-called bivalent vaccine targets the Beta variant – first identified in South Africa – as well as the original Wuhan strain of the virus.
Sanofi said an upgraded version of the COVID-19 vaccine candidate the French drugmaker is developing with GSK showed potential in two trials to protect against the virus’s main variants of concern, including the Omicron BA.1 and BA.2 strains, when used as a booster shot.
Advisers to the U.S. Food and Drug Administration will consider whether to recommend Novavax Inc.’s COVID-19 vaccine for adults, which the drugmaker hopes can become the shot of choice among some American vaccine skeptics.
North Korea on May 21 reported more than 200,000 new patients suffering from fever for a fifth consecutive day, as the country fought its first confirmed coronavirus outbreak.
Pharmacovigilance, the industry term for drug safety, was unfamiliar to most of the general public before March 2020. But as the coronavirus pandemic unfolded, its rapid spread thrust drug safety into the spotlight. The public is more aware of drug safety and health regulators’ role than ever — and as the demand for pharmacovigilance information rises, the industry has had to find ways to keep up — according to Beena Wood, VP of safety at ArisGlobal.
