By Anna Edney
- Advisory committee votes that shot’s benefit outweigh risks
- FDA, Pfizer bolster instructions for providers and recipients
Moderna Inc.’s Covid-19 vaccine won backing from a panel of experts who advise U.S. regulators, setting the stage for its shot to be the second vaccine cleared in the U.S. in as many weeks.
Food and Drug Administration advisers voted 20 to 0, with one abstention, on Thursday that the benefits of the vaccine outweigh any risk, giving a boost to efforts to ramp up the U.S. immunization campaign. The effort is initially focusing on health-care workers and seniors who live in long-term care facilities. The FDA could authorize the shot within the next day.
Moderna’s product is based on the same technology as a shot made by Pfizer Inc. and BioNTech SE that was cleared by the FDA last week, and like that vaccine showed a high degree of efficacy in late-stage clinical trials. At Thursday’s advisory meeting, some of the discussion focused on a handful of allergic reactions experienced by people in the U. S. and U.K. who got the Pfizer shot.
(CNN) As the United States on Thursday surpassed 17 million official Covid-19 cases, a US Food and Drug Administration advisory panel recommended a second coronavirus vaccine for the country.
The developments come as the US, after starting distribution of its first authorized vaccine this week, is dealing with record rates of daily cases, daily deaths and numbers of Covid-19 patients in hospitals.
The FDA is widely expected to grant emergency use authorization for Moderna’s vaccine candidate — as it did for Pfizer’s vaccine last week — after its vaccine advisory panel voted to recommend it.
The Centers for Disease Control and Prevention would need to greenlight the vaccine before shots can be administered — and a CDC advisory panel is expected to meet on the matter Saturday, raising the possibility that the Moderna vaccine could be used next week.
The recently authorized Pfizer vaccine, meanwhile, has been administered to hundreds of US health care workers this week, and drug store chains CVS and Walgreens are helping to get shots to long-term care residents and staff members.
Dr. Rachel Zhang, a researcher in the F.D.A.’s office of vaccines research and review, said that the agency found the vaccine worked equally well in different groups of volunteers defined by race or ethnicity, gender or age.
She also said that the data from the trial hinted that protection from the vaccine starts to emerge soon after people get the first dose. However, she cautioned that there wasn’t enough data to come to a clear conclusion.
Moderna is developing eight other vaccines that use mRNA. The company has tested them in animals and in 1,700 people, and has not had cases of anaphylaxis or other severe allergic reactions linked to the vaccine, Dr. Jacqueline Miller of Moderna said. One anaphylaxis case occurred two months after vaccination, in a person with a soy allergy. Anaphylactic reactions to vaccines generally occur within minutes or even seconds after the shots are administered.
Voting member Dr. James Hildreth was the only member to not vote yes. He said he decided to abstain because he was “uncomfortable” endorsing the vaccine for everyone age 18 and older.
“In the midst of a pandemic and with limited vaccine supply, a blanket statement for individuals for 18 years and older is just too broad,” said Hildreth, also president and CEO of Meharry Medical College.“I’m not convinced for all of those age groups the benefits do actually outweigh the risk.”
Initial doses will be limited as manufacturing ramps up, with officials predicting it will take months to immunize everyone in the U.S. who wants to be vaccinated. The Centers for Disease Control and Prevention has provided states with an outline that recommends prioritizing health-care workers and nursing homes, but states can distribute the vaccine as they see fit.
The advisory panel on Thursday voted 20-0 with one abstention that the benefits of the Moderna vaccine outweigh the risks for those aged 18 and over. The same committee last week backed the Pfizer/BioNTech vaccine, leading to its authorisation for emergency use the following day.