Pfizer/BioNTech File for Updated EUA Allowing COVID-19 Boosters in All Adults
Pfizer and BioNTech are seeking an amended Emergency Use Authorization (EUA) from the FDA allowing their COVID-19 vaccine booster for general use in adults over age 18.
The companies filed a request yesterday, supported by data from a phase 3 trial evaluating the efficacy and safety of a 30-µg booster in more than 10,000 volunteers “during a period when the Delta variant was the prevalent strain.”
If the companies get the more sweeping approval, that would give the Biden administration what it was seeking in August when it announced it wanted to provide boosters for all (DID, Aug. 24). This resulted in much controversy at the time, as no boosters were yet authorized.
About a month later, FDA approved an expanded EUA for Pfizer’s and BioNTech’s booster for people over age 65 and people 18 and over who are at high risk of severe infection due to existing comorbidities or due to their place of work, including frontline healthcare workers and teachers (DID, Sept. 23). The booster was green-lighted by the Centers for Disease Control and Prevention for those groups Sept. 24 (DID, Sept. 27).
Meanwhile, rival mRNA COVID-19 vaccine maker Moderna has filed its application with the European Medicines Agency (EMA) for its 50 µg two-dose vaccine (called Spikevax) in children ages six to 11 years old after new data showed the vaccine was safe and effective in 100 percent of kids in that age group observed two weeks after the first dose, said the company.
Additionally, Moderna’s study showed its vaccine was 65 percent effective at preventing asymptomatic infection two weeks after the first dose.
Moderna’s study was conducted in collaboration with the National Institute of Allergy and Infectious Diseases and the Biomedical Advanced Research and Development Authority.
The EMA’s Committee for Medicinal Products for Human Use gave the thumbs up to Spikevax for adolescents 12 years and older on July 23.
The company said it also plans to submit its data on kids age six to 11 to other regulatory agencies to seek approval.
While vaccine makers are pushing toward new horizons, so are the makers of the only approved pill to treat COVID-19. Merck and Ridgeback Biotherapeutics, makers of molnupiravir, announced that the U.S. government will pay close to $1 billion for an additional 1.4 million courses of the drug.
This is in addition to the 1.7 million courses the government agreed to buy in June, pending U.S. approval of the drug, for $1.2 billion. This brings the total the government plans to spend on molnupiravir to $2.2 billion.
Molnupiravir got its first green light from a regulatory body Nov. 4 when the UK’s Medicines and Healthcare products Regulatory Agency authorized it for the treatment of mild-to-moderate COVID-19 in adults who have at least one risk factor for developing severe illness (DID, Nov. 5).
Thus far, that’s its only approval. Merck and Ridgeback still await authorization from the FDA, which could come early next month.
Merck said it plans to make 10 million courses of the drug by the end of 2021, with at least 20 million slated to be made next year.
Meantime, the European Union is said to be negotiating with Merck and Pfizer over contracts for their oral COVID-19 treatments. Reportedly, Merck’s talks are further along, since its molnupiravir, which cuts the risk of hospitalization and death by 50 percent, now has approval in the UK.
Pfizer’s investigational oral antiviral Paxlovid, which seems slated to soon go head to head with molnupiravir globally, showed in the interim analysis of a phase 2/3 study that it could cut the risk of COVID-19-associated hospitalizations and death by 89 percent compared to placebo. The study was stopped due to “overwhelming efficacy,” the company said (DID, Nov. 9).
Pfizer plans to ask the FDA to grant Paxlovid an EUA “as soon as possible,” the company said. — Suz Redfearn