After weeks of vague timelines, it looks like Moderna and Pfizer-BioNTech’s omicron-adapted booster shots are just around the corner.
The FDA could approve an anti-variant mRNA vaccine as early as Wednesday, Politico first reported, citing three of his people close to the decision.
In return, the Biden administration would be prepared to roll out a reconstituted vaccine shortly after Labor Day to prevent a possible resurgence of the virus later this year, the news agency said. , designed to provide stronger protection against not only the original SARS-CoV-2 strain, but also the BA and BA.5 Omicron subvariants.
FDA declined to comment on Politico’s story. The publication’s sources warned that the exact timing of emergency calls could change as U.S. regulators rush to complete their investigations.
It comes days after BioNTech and Moderna completed their application for the COVID-19 booster.
Pfizer and its German mRNA partner, BioNTech, submitted an application last Monday seeking approval for boosters specifically for adults and adolescents aged 12 and over.
At the same time, the partners have also initiated the application process with the European Medicines Agency.
Meanwhile, Moderna submitted a bid for the 50 µg dose on Wednesday and completed its application Wednesday, based on preclinical and clinical trial data for the company’s Omicron-targeted booster candidate BA.1.
Moderna’s upgraded intake is expected to be legal for adults 18 years of age and older.
The U.S. Centers for Disease Control and Prevention (CDC) said in its mid-August planning guide that the federal government will deploy a total of 175 million doses of Moderna combined with boosters from Pfizer and BionTech.
After the FDA declares a state of emergency, the CDC must still approve recordings for public distribution. Politico noted that the CDC has scheduled meetings of the External Vaccine Advisory Board on Thursday and Friday.
Some critics have commented on the pace at which the revised Pfizer and Moderna vaccines appear to be moving through the regulatory process, with the main point of contention being that the government is allowing boosters without support for human trials.
Health officials in the Biden administration claim there is enough evidence behind the vaccine, increasing urgency to bring it to market by the fall.
FDA says no human data on bivalent boosters Instead, consider actual evidence from similar mRNA injectors, human data from other bivalent vaccines, and data from studies in mice, Politico said.
The news service compared the move to the process surrounding annual renewals of the flu vaccine. This is only tested on animals each year before being released to the market due to tight deadlines for manufacturers.
Nonetheless, influenza vaccination is also not based on relatively new mRNA technology.
Pfizer plans to begin human safety and efficacy trials later this month, and Moderna is already proceeding with Phase 2/3 trials, according to disclosures from the companies last week.
Pfizer and Moderna’s vaccines continue to work together to fight COVID-19 in the U.S. and abroad, but discord is brewing between mRNA rivals.
Late last week, Moderna filed patent infringement lawsuits in the United States and Germany, alleging that it infringed a Massachusetts-based biotech patent filed by Pfizer and his BioNTech between his 2010 and his 2016.
Moderna claims it aims to “invest billions of dollars in development and protection of its patented and innovative mRNA technology in the decade leading up to the COVID-19 pandemic.”
Pfizer and her BioNTech have vowed to “vigorously defend” the lawsuit.
Moderna is not removing the Pfizer and BioNtech vaccines from the market.
In developed markets, however, Moderna expects mRNA’s competitors to “respect intellectual property rights and consider commercially reasonable licensing.” Pfizer and BioNTech “failed” to apply for such licenses, Moderna claims.