Moderna Asks FDA To Allow All Adults To Get Second Covid Booster
Moderna's application Thursday for FDA approval of a fourth covid vaccine shot for anyone 18 or older is broader than the one submitted by Pfizer and BioNTech earlier this week, which asked that an additional dose be authorized for people 65 and up. Both applications rely on data from Israel, which news outlets explore further.
The Washington Post:
Moderna Seeks FDA Authorization For A Second Booster Dose Of Its Coronavirus Vaccine For All Adults
Biotechnology company Moderna on Thursday asked the Food and Drug Administration to allow adults 18 and older to receive a second booster shot of the company’s mRNA vaccine amid concerns that immune protection from the vaccines wanes over time. Moderna’s application is substantially broader than what Pfizer and its German partner, BioNTech, sought earlier in the week — FDA authorization for a second booster shot for adults 65 and older. (Shepherd, 3/17)
AP:
Moderna Seeks FDA Authorization For 4th Dose Of COVID Shot
In a press release, the company said its request for approval for all adults was made “to provide flexibility” to the Centers for Disease Control and Prevention and medical providers to determine the “appropriate use” of a second booster dose of the mRNA vaccine, “including for those at higher risk of COVID-19 due to age or comorbidities.” U.S. officials have been laying the groundwork to deliver additional booster doses to shore up the vaccines’ protection against serious disease and death from COVID-19. The White House has been sounding the alarm that it needs Congress to “urgently” approve more funding for the federal government to secure more doses of the COVID-19 vaccines, either for additional booster shots or variant-specific immunizations. (Miller, 3/18)
USA Today:
Moderna Seeks FDA Authorization For A 4th COVID Vaccine Shot For All Adults
Moderna said its request for emergency use authorization is based partly on recently published data from the U.S. and Israel following the emergence of the omicron variant. The company did not specify what the U.S. and Israeli data showed, but Israel approved a fourth COVID vaccine shot for vulnerable people over the age of 18 in January 2022. Additionally, a study of more than 1 million Israelis over 60 showed that those who got a fourth dose of the Pfizer-BioNTech vaccine were half as likely to become infected and four-times less likely to fall severely ill than those who had only three shots. That study has not been peer-reviewed. (Tebor, 3/17)
How effective is a second booster? —
CIDRAP:
Israeli Study Points To Modest 4-Dose Vaccine Protection Against Omicron
Four-dose efficacy of mRNA vaccines against symptomatic Omicron COVID-19 infection is modest, according to a research letter yesterday in the New England Journal of Medicine that described a small study in Israel. Of 1,050 eligible Israeli healthcare workers, 154 received a fourth dose of Pfizer and 120 received a fourth dose of Moderna. The researchers selected two age-matched controls from the remaining eligible participants for each person vaccinated. (3/17)
Los Angeles Times:
Second COVID Booster Shot Does Little To Stop Omicron, Study Finds
Israeli healthcare workers who were boosted with a fourth shot of COVID-19 vaccine at the height of the Omicron wave were only marginally more protected against reinfection than their peers who had received three jabs of vaccine, researchers reported Wednesday. Compared to getting two initial doses and one booster shot of Pfizer and BioNTech’s Comirnaty vaccine, adding a second booster shot reduced the rate of coronavirus infection by just 30%. (Healy, 3/16)
And more on the development of covid vaccines —
Axios:
Coronavirus Vaccine Deadline Adds Urgency To COVID Funding Impasse
The U.S. government needs to contract with coronavirus vaccine makers by the end of the month in order to have enough booster shots for most Americans this fall but can't proceed until Congress approves more money, according to two senior Biden administration officials. The debate over another round of booster shots is already heating up, and some experts are skeptical that they'll even be needed soon. But there's no telling what will happen between now and September, when the administration wants to have doses on-hand in case they're needed. (Owens, 3/18)
Stat:
Alnylam Sues Pfizer, Moderna For Patent Infringement On Covid Vaccines
Alnylam Pharmaceuticals has filed separate lawsuits alleging that Pfizer and Moderna infringed on its patents in developing their Covid-19 vaccines, the latest dispute over valuable intellectual property stemming from the pandemic. In each suit, Alnylam claims the companies used its lipid nanoparticles technology that carries and delivers RNA-based therapies or vaccines in the body. RNA plays a key role in turning the instructions held in the DNA of a person’s genome into functional proteins in cells. Both Pfizer and Moderna developed and now market mRNA-based vaccines, and mRNA is a type of RNA. However, mRNA is easily degraded and the lipid technology provides protection for delivery. (Silverman, 3/17)
