Morning Briefing
Summaries of health policy coverage from major news organizations
Pfizer Asks FDA For Updated Covid Booster OK Ahead Of Clinical Trials
Pfizer and BioNTech said Monday that they have asked the Food and Drug Administration to authorize a new booster shot targeted at the Omicron BA.4/BA.5 strain of the coronavirus that causes Covid-19, the first step in a process that could lead to more effective booster shots. (Herper, 8/22)
Following the FDA's guidance, the data the drugmakers are submitting represents a departure from what's been used in earlier vaccine authorizations. Instead of waiting for results from human trials, the FDA asked the drug companies to initially submit only the results of tests on mice, as NPR reported last week. Regulators will rely on those results 鈥 along with the human neutralizing antibody data from earlier BA.1 bivalent booster studies 鈥 to decide whether to authorize the boosters. (Huang and Stone, 8/22)
In a statement, Pfizer said its EUA would clear the booster for use in people ages 12 and older. The company said the clinical trial is expected to begin later this month, but it has already scaled up production and will be ready to ship the vaccine in September, as soon as the FDA approves the emergency use authorization (EUA) application. To speed the consideration of the EUA, the FDA told Pfizer it could submit clinical data for its bivalent BA.1 vaccine alongside preclinical and manufacturing data on its BA.4/BA.5 vaccine. Preclinical data in animals suggest that the BA.4/BA.5 bivalent booster prompts a strong neutralization antibody response against Omicron BA.1, BA.2, and BA.4/BA.5 variants, as well as to the original SARS-CoV-2 virus. (Schnirring, 8/22)
鈥淭he agility of the mRNA platform, together with extensive clinical experience with the Pfizer-BioNTech COVID-19 Vaccine, has allowed us to develop, test and manufacture updated, high-quality vaccines that align to circulating strains with unprecedented speed,鈥 Albert Bourla, Pfizer鈥檚 CEO, said in a statement. 聽(Sullivan, 8/22)
Moderna is expected to file a similar application soon for updated boosters for adults. The U.S. has a contract to buy 105 million of the Pfizer doses and 66 million Moderna ones, assuming FDA gives the green light. (Neergaard, 8/22)
