First results from the U.K. Cov-Boost trial, looking at responses to a fourth dose of an mRNA COVID-19 vaccine, show that antibody levels increase more than after the third dose, confirming the precautionary move to give the most vulnerable a second COVID-19 booster in advance of immune response data being available.
The U.S. FDA’s efficacy bar for COVID-19 vaccines for the youngest children may be lower than the 50% required for the adult vaccines, according to Peter Marks, director of the agency’s Center for Biologics Evaluation and Research.<
The U.S. COVID-19 vaccine program is at risk of “booster fatigue,” which will undermine public confidence in the vaccines, several members of the CDC’s Advisory Committee on Immunization Practices (ACIP) said April 20 as they met to discuss the future of the vaccines. Rather than relying on boosters, “we need to use our expertise to advocate for something that’s better,” something that resolves the ill effects of COVID-19, whether it’s mild or severe, said Lynn Bahta, an immunization program clinical consultant for the Minnesota Department of Health.
When the U.S. FDA convened its Vaccines and Related Biological Products Advisory Committee (VRBPAC) April 6 to advise on a path forward to the next generation of COVID-19 vaccines and boosters, there was a lot of talk about all the unknowns.
Citing the lack of clear evidence that vaccine protection against severe COVID-19 disease is substantially waning in the EU in people younger than 80, the European Centre for Disease Prevention and Control and the EMA’s COVID-19 task force concluded that it’s too early to consider using a fourth dose, or second booster, of mRNA COVID-19 vaccines in the general population.
"Now is the time to discuss the need for future boosters as we aim to move forward safely, with COVID-19 becoming a virus like others such as influenza that we prepare for, protect against and treat,” the FDA’s Peter Marks said in announcing an April 6 virtual meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC).
Alnylam Pharmaceuticals Inc. has filed suits against both Pfizer Inc. and Moderna Inc. over alleged infringements of its patent on biodegradable cationic lipids that it said "are foundational to the success of the mRNA COVID-19 vaccines."
For years, a vaccine against respiratory syncytial virus (RSV) has been out of reach. But this could change thanks to several candidates in the late-stage pharma pipeline. Among them, Moderna Inc. became one of the front-runners in the race to develop a vaccine for the virus after this week announcing that its entrant in the contest, mRNA-1345, is moving into phase III development.
The deadly SARS-CoV-2 virus that has cost nearly 6 million lives worldwide and disrupted global economies has brought the biopharma industry $82 billion in sales revenue since the start of the pandemic, with guidance for another $88 billion this year.
As the Biden administration continues to play musical chairs with key U.S. federal health leadership positions, its latest move is naming Francis Collins to serve as science adviser to the president and co-chair of the President’s Council of Advisers on Science and Technology.
