GSK plc is preparing filings for its respiratory syncytial virus (RSV) vaccine in older people following supportive late-stage trial results, a product which could play a vital role as it spins out its consumer business arm. The vaccine could be a potential blockbuster for GSK, worth as much as $7 billion in peak annual sales if approved in all its potential uses – although trials in pregnant women remain on hold because of safety concerns.
More than two years into the COVID-19 pandemic and nearly 18 months since a vaccine was first available for adults, the U.S. is on the cusp of having vaccines available to the youngest Americans.
Based on a preliminary data analysis of its second and newest COVID-19 booster candidate, Moderna Inc. said it plans to ask the U.S. FDA to approve mRNA-1273.214 ahead of potential shipping in late summer 2022. The vaccine contains mRNA-1273 (Spikevax) and a vaccine candidate targeting omicron. New phase II/III results show the candidate hitting all the study’s primary endpoints when compared to Moderna’s original vaccine, mRNA-1273.
Given the safety and efficacy data presented June 7 for Novavax Inc.’s COVID-19 vaccine, NVX-CoV2373, it came as no surprise when the U.S. FDA’s Vaccines and Related Biologic Products Advisory Committee voted 21-0, with one abstention, to support an emergency use authorization for the vaccine, which is already approved and being used in many other countries, including the EU and Canada.
Shares of Novavax Inc. dropped 19% after briefing documents released ahead of the U.S. FDA’s June 7 advisory committee raised concerns about risks of myocarditis associated with COVID-19 vaccine NVX-CoV2373, though reviewers also noted the vaccine could offer protection against the omicron variant. The stock (NASDAQ:NVAX) closed June 3 at $44.76, down $11.21.
Although the death toll in the U.S. is nearing 1 million lives lost, signs continue to suggest that an end is in sight for the COVID-19 pandemic, the most disruptive global health crisis in a century.
Glaxosmithkline plc (GSK) pledged $2.1 billion up front and as much as $1.2 billion in development milestone payments to take over privately held Affinivax Inc. and bring aboard the phase II-stage, next-generation, 24-valent pneumococcal vaccine candidate, AFX-3772. London-based GSK is buying all outstanding shares of Affinivax, of Cambridge, Mass., for $2.1 billion upon closing the deal in the third quarter of this year, and two potential milestone payments of $600 million to be paid if certain pediatric development goals are reached.
Two days after the U.S. FDA authorized a single booster dose of the Pfizer Inc.-Biontech SE COVID-19 vaccine for children ages 5 to 11, the U.S. CDC’s Advisory Committee on Immunization Practices (ACIP) gave its blessing to the third dose.
Shares in Bavarian Nordic A/S jumped after the company received an order of its monkeypox vaccine from an “undisclosed European country.” The order comes amid a small but growing number of cases of monkeypox in Europe, with nine reported in the U.K. and further cases in Portugal and Spain, bringing the total in the continent to more than 20.
A year after the World Health Organization's (WHO) Independent Panel for Pandemic Preparedness and Response called for reforms to make COVID-19 the last pandemic, the panel remains solidly frustrated in its lack of progress.
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