The decision by the expert panel, delivered on Monday evening, sets up the vaccine for full approval by the government.
Tag Archive for: COVID vaccine
The U.S. biotech firm Moderna submitted a regulatory application to the European Medicines Agency.
A panel of outside advisers to the U.S. Food and Drug Administration is scheduled to meet on June 15 to discuss strain selection for this year’s COVID-19 booster shots, and regulators are expected to make their decision shortly afterward.
The amendment cuts the number of COVID-19 vaccines that the EU must buy and pushes the delivery deadline to 2026.
The company announced plans to cut 25% of its workforce and unveiled promising data for its COVID-influenza combination vaccine and two other shots, raising hopes of a recovery for the cash-strapped biotech.
BioNTech, which reported it had built up an 18.6 billion euro ($20.55 billion) balance of cash and receivables at the end of March, has pursued a string of takeovers and alliance deals to broaden its work on cancer treatments.
Pfizer beat estimates for first-quarter profit, helped by steady demand for its COVID products and said it expects newer drugs to contribute to growth later this year, sending its shares up nearly 3% in premarket trading.
The move comes as the bloc plans to revamp laws governing the $148 billion pharmaceuticals industry in the hope of reviving investment and boosting access to affordable drugs at a time when health budgets are drained by the costs of treating COVID-19.
Today the World Health Organization changed its recommendations for COVID-19 vaccines, suggesting that high-risk populations should receive an additional dose 12 months after their last booster.
Moderna Inc’s chief executive defended the company’s plan to quadruple the price of its COVID-19 vaccine, telling a U.S. Senate committee hearing it will no longer have the economies of scale from government procurement when the shots move into the private market.