FDA Approves Both Moderna, Pfizer Booster Shots For All Adults
The Food and Drug Administration authorized booster shots of the two mRNA covid vaccines approved in the U.S. for all adults 18 or older. The Centers for Disease Control and Prevention must still give its OK. In other vaccine news, news outlets report on efforts to free-up intellectual property rights.
AP:
US Expands COVID Boosters To All Adults, Final Hurdle Ahead
U.S. regulators on Friday opened up COVID-19 booster shots to all adults, expanding the government’s campaign to shore up protection and get ahead of rising coronavirus cases that may worsen with the holidays. Pfizer and Moderna announced the Food and Drug Administration’s decision after at least 10 states already had started offering boosters to all adults. The latest action simplifies what until now has been a confusing list of who’s eligible by allowing anyone 18 or older to choose either company’s booster six months after their last dose — regardless of which vaccine they had first. (Neergaard and Perrone, 11/19)
Stat:
FDA Expands Emergency Authorization For Covid Booster Shots To All Adults
The new policy still requires signoff from the Centers for Disease Control and Prevention to go into effect. The CDC’s vaccine advisory panel will meet Friday on the issue. But if the CDC agrees with the FDA, this will be in effect the completion of a Biden administration promise, announced in mid-August, to provide all American adults Covid booster doses this fall. “Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech Covid-19 vaccine for individuals 18 years of age and older helps to provide continued protection against Covid-19, including the serious consequences that can occur, such as hospitalization and death,” acting FDA Commissioner Janet Woodcock said in a statement announcing the agency’s ruling. (Branswell, 11/19)
The Washington Post:
FDA Authorizes Pfizer-BioNTech, Moderna Boosters For All Adults
The new federal approach, many experts note, essentially ratifies what has been occurring on the ground; most people who have sought the shots have gotten them simply by telling pharmacists they are eligible. Even so, only about 37 percent of fully vaccinated people over 65, and 17 percent of all adults have gotten boosters, according to the CDC. (McGinley, 11/19)
Reuters:
Wait What? FDA Wants 55 Years To Process FOIA Request Over Vaccine Data
Freedom of Information Act requests are rarely speedy, but when a group of scientists asked the federal government to share the data it relied upon in licensing Pfizer’s COVID-19 vaccine, the response went beyond typical bureaucratic foot-dragging. As in 55 years beyond. That’s how long the Food & Drug Administration in court papers this week proposes it should be given to review and release the trove of vaccine-related documents responsive to the request. If a federal judge in Texas agrees, plaintiffs Public Health and Medical Professionals for Transparency can expect to see the full record in 2076. (Greene, 11/18)
In news on vaccines, and covid drug development —
The Wall Street Journal:
Prospects Of Intellectual-Property Waiver On Covid-19 Vaccines Fade
An agreement to waive the intellectual-property rights underpinning Covid-19 vaccines—a prospect poor countries have hoped would ease supplies to the developing world—is becoming increasingly unlikely, say people familiar with the situation, with the U.S. not acting to bridge disagreements between developing world countries and those opposing such a measure. In May, the Biden administration said it would support temporarily suspending patents and other IP linked to the shots to allow developing countries to produce the Covid-19 vaccines created by big drug companies. (Steinhauser, Hinshaw and Hayashi, 11/18)
Stat:
Proposal To Waive IP Rights For Covid Vaccines And Drugs Appears Unlikely
A controversial proposal for the World Trade Organization to temporarily waive intellectual property rights and provide greater access to Covid-19 medical products appears unlikely to pass, according to people tracking the latest round of meetings at the global agency. Despite a year-long debate, disagreement remains on the fundamental question of whether a waiver is appropriate and the most effective way to tackle inequitable distribution of Covid-19 vaccines and treatments, according to a trade official who is based in Geneva, Switzerland, where talks are being held. The WTO needs consensus from all of its 164 members for the proposal to be adopted. (Silverman, 11/18)
Reuters:
CureVac To Begin Trials For Next-Generation COVID-19 Shots Within Months
German biotechnology company CureVac NV said on Thursday clinical trials for its second-generation COVID-19 vaccine are expected to start within the next few months. Earlier on Thursday, the company published data that showed its next-generation shot, CV2CoV, produced neutralizing antibodies in monkeys that were comparable to those produced by Pfizer Inc's (PFE.N) approved vaccine. The efficacy was also greater than the company's first-generation vaccine, it added. In October, CureVac gave up on its first-generation COVID-19 vaccine candidate, CVnCoV, to focus on collaborating with GSK (GSK.L) to develop improved mRNA vaccine technology. (11/18)
Reuters:
AstraZeneca Says To Seek Commercial Price For Preventive Antibody Cocktail
AstraZeneca (AZN.L) said its antibody cocktail against COVID-19 would - unlike its vaccine - be priced commercially as it negotiates supply contracts with governments around the globe. "We are looking at a commercial pricing strategy. That is part of our negotiations with governments," Iskra Reic, Astra's Executive Vice President for vaccines and immune therapies, said in a media call on Thursday. She added that the group's main objective was to make the shot affordable and broadly available. (11/18)
