Moderna’s New Covid-19 Shot Shows Promise Against Omicron Subvariants
The strong immune responses against the Omicron subvariants in a new study reinforced Moderna’s plan to seek regulatory authorization to release an updated booster shot in August.
(Reuters) -Pfizer Inc and partner BioNTech SE said on Wednesday they signed a $3.2 billion deal with the U.S. government for 105 million doses of their COVID-19 vaccine, which could be delivered as soon as later this summer. The deal includes supplies of a retooled Omicron-adapted vaccine, pending regulatory clearance, according to Pfizer. Drugmakers have been developing vaccines to target the Omicron variant that became dominant last winter.
The Food and Drug Administration’s vaccines advisers voted in favor of updating Covid-19 booster shots to protect specifically against the Omicron variant.
An expert advisory vaccine panel for the Food and Drug Administration (FDA) on Tuesday voted in favor of recommending updated COVID-19 vaccines specifically designed to combat the omicron variant. Among the voting members of the FDA’s Vaccines and Related Biological Products Advisory Committee, 19 voted in favor of recommending an omicron-specific booster, while two voted…
Booster shots are recommended for everyone 5 and older. And people 50 and older are eligible for a second booster dose.A healthcare worker prepares COVID-19 vaccines for third doses at a senior l...
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As per the modified supply agreement with the government, Lilly will provide an additional 150,000 doses of bebtelovimab for about $275 million. The drug has also shown effectiveness against the Omicron variant. The FDA authorized the drug earlier this year for emergency use in patients with mild-to-moderate COVID-19 who are at high risk of progression to severe disease, including hospitalization or death.
An FDA panel voted Tuesday to reformulate COVID-19 booster shots for the fall to more directly target the omicron viral variant.
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South Korea approved its first domestically developed COVID-19 vaccine, manufactured by SK bioscience Co Ltd, for general public use following positive clinical data, authorities said on Wednesday. The SKYCovione vaccine was authorised for a two-dose regimen on people aged 18 or older, with shots given four weeks apart, according to the Ministry of Food and Drug Safety. In a phase III clinical trial of 4,037 adults, SKYCovione induced neutralizing antibody responses against the SARS-CoV-2 parental strain, SK bioscience said in a statement.
The FDA voted to update the current COVID-19 vaccines to include the BA4/BA5 strain of omicron.
Pfizer (PFE) announces the name of the new company that it formed with its partner, Roivant Sciences (ROIV), to develop and market its dual TYK2/JAK1 inhibitor.
The FDA's VRBPAC committee recommends updated COVID-19 vaccine boosters that target the Omicron variant to improve vaccine effectiveness.
(Reuters) -Advisers to the U.S. Food and Drug Administration on Tuesday recommended a change in the design of COVID-19 booster shots this fall in order to combat more recently circulating variants of the coronavirus. The FDA's Vaccines and Related Biological Products Advisory Committee voted 19-2 that the next wave of COVID booster shots should include a component that targets the Omicron variant of the coronavirus. The FDA plans to decide by early July on what the design of the boosters should be.
The European Medicines Agency says it will begin reviewing data to decide if a smallpox vaccine made by the pharmaceutical company Bavarian Nordic might also be authorized for monkeypox, amid a growing outbreak of the disease across the continent. In a statement on Tuesday, the EU drug regulator noted that the vaccine, known as Imvanex in Europe but sold as Jynneos in the U.S., is already cleared for use against monkeypox by American regulators. In Europe, the vaccine is only authorized in adults for the prevention of smallpox, which is related to monkeypox.
The company's stock also took a substantial dive early last month after the same drug missed its mark in two other diseases.
The advisory committee signaled a preference for the strain composition to target the BA.4 and BA.5 subvariants.
Roivant Sciences Ltd (NASDAQ: ROIV) and Pfizer Inc (NYSE: PFE) unveiled Priovant Therapeutics, dedicated to developing and commercializing novel therapies for autoimmune diseases. Priovant was established in September 2021 through a transaction between Roivant and Pfizer. Pfizer licensed oral and topical brepocitinib's global development rights and US and Japan commercial rights to Priovant. Pfizer holds a 25% equity ownership interest in Priovant. Brepocitinib is a potential first-in-class dual
A new COVID-19 booster strategy should focus on developing new shots that better protect against omicron and its subvariants.