Covid-19 roundup: Pfizer/BioNTech launch Omicron-specific vaccine trial; UK to recruit thousands more for molnupiravir study
Pfizer and BioNTech announced Tuesday that they’ve initiated a clinical study to evaluate the safety, tolerability and immunogenicity of an Omicron-targeted vaccine candidate in healthy adults 18 through 55 years of age, although it remains unclear when, if ever, that vaccine might be necessary.
Drawing on some of the participants from the companies’ Phase III booster study, the trial will enroll up to 1,420 participants and evaluate three groups of healthy adults up to the age of 55, including one group who received 2 doses of the Pfizer vaccine and will get one shot of the Omicron-specific booster, one group that received three doses of the Pfizer vaccine and will get one of the Omicron-based vaccines, and then a third group receiving three doses of the Omicron-based vaccine.
“While current research and real-world data show that boosters continue to provide a high level of protection against severe disease and hospitalization with Omicron, we recognize the need to be prepared in the event this protection wanes over time and to potentially help address Omicron and new variants in the future,” Kathrin Jansen, head of vaccine R&D at Pfizer, said in a statement.
The companies said they expect to produce 4 billion doses of the Pfizer/BioNTech vaccine this year, and that capacity is not expected to change if an Omicron-adapted vaccine is required.
Britain looks to enroll thousands more in molnupiravir trial to see if Merck’s pill works
The UK government said on Tuesday it needs to recruit 6,000 more people into a trial for Merck’s Covid-19 pill molnupiravir before it can be distributed more widely.
First approved by Britain’s drug regulator in November, the UK launched a national study to establish the best way to use the drug.
According to Reuters, the UK health ministry said that while more than 4,500 trial participants had signed up for the trial, dubbed Panoramic, thousands more were needed to gather the data needed.
European and Canadian regulators offer a peek into Moderna’s vaccine data
The European Medicines Agency and Health Canada took the proactive step toward more transparency around Covid-19 vaccines on Tuesday, with the release of data on Moderna’s vaccine.
EMA & @GovCanHealth published #ClinicalData used to support their authorisations of Moderna Spikevax #CovidVaccine for adolescents aged 12 to 17.
Read more: https://t.co/ZGZ3nrKF9W
We are the first regulatory authorities worldwide to provide such broad access to clinical data.
— EU Medicines Agency (@EMA_News) January 25, 2022
The EMA previously released data on the Covid vaccines from Pfizer/BioNTech, J&J, AstraZeneca, and Gilead’s Covid treatment remdesivir.