DCR Health: FDA advisers recommend second coronavirus vaccine, with agency approval expected soon.☕☕☕

Ayyyeee… What’s Goodie Everyone. So I got some tea and it involves another coronavirus vaccine and the FDA.

Moderna’s coronavirus vaccine recieved the green light from a Food and Drug Administration advisory committee on Thursday, giving way for authorization of a second shot aimed at slowing a pandemic that has killed nearly 310,000 people in the United States. The panel voted almost unanimously 20 in favor, with one abstention that the benefits of the highly effective vaccine outweighed its risks for people 18 years of age and older. The FDA plans to authorize the vaccine Friday, according to knowledgeable individuals who spoke on the condition of anonymity because they were not authorized to speak publicly.

The advisory committee’s action came on the same day the nation set three grim single day records, for cases (more than 250,000), hospitalized Covid-19 patients (more than 114,000) and deaths (more than 3,400). California in the past 48 hours posted more than 100,000 new infections, and the governor has readied a mass fatality plan. At the same time, questions flared about the availability of the first coronavirus vaccine to receive federal authorization, with officials in multiple states saying they had been told their second shipments of Pfizer-BioNTech’s inoculation had been slashed for next week.
That development sowed confusion, led to dueling statements from Pfizer and federal officials about who was to blame, and raised questions about whether a promise to deliver shots to 20 million people by the end of the year would be kept.

Looming supply issues made clear that even with unprecedented scientific success, the limited availability of vaccines would not prevent a dark winter. The FDA authorized the Pfizer-BioNTech vaccine last Friday. The first doses were administered Monday to healthcare workers. Questions about the supply have persisted, as Pfizer and the U.S. government have been in negotiations about securing more doses after the first 100 million already purchased for nearly $2 billion.

Moderna developed its vaccine in partnership with the National Institute of Allergy and Infectious Diseases, with the government underwriting the research and development of the vaccine and the advanced purchase of 200 million doses, bringing the government investment to $4.1 billion.

In Thursday’s advisory committee meeting, the FDA addressed an issue that did not directly involve the Moderna vaccine. There were reports of allergic reactions to the Pfizer-BioNTech vaccine, including in two healthcare workers in Alaska, one of whom was hospitalized. Both are recovering. “While the totality of data at this time continue to support vaccinations under the Pfizer (emergency use authorization) without new restrictions, these cases underscore the need to remain vigilant during the early phase of the vaccination campaign,” FDA vaccine expert Doran Fink said.

The heightened concern about possible allergic reactions will also pertain to the Moderna vaccine, because it uses the same genetic technology as Pfizer-BioNTech. An expert panel convened by the National Institutes of Health on Wednesday tried to discern which of the components of the vaccines might trigger an allergic reaction, Moderna chief medical officer Tal Zaks said, but he added that differences between the two vaccines make it uncertain whether they both could trigger the rare reactions.

The FDA will also closely monitor for cases of Bell’s palsy,which is a condition that causes temporary facial paralysis, as the vaccine is rolled out to more people. There were four cases of Bell’s palsy among people that received the Pfizer-BioNTech vaccine in its trial and three in the group that received the Moderna vaccine in its trial. The FDA said there wasn’t a clear causal link but acknowledged that the combined data from the two trials raised questions. “It’s something we are looking into and thinking much about,” said Rachel Zhang, FDA medical officer.

Moderna’s chief scientific officer Melissa J. Moore explained that a snippet of genetic material, called messenger RNA, is encapsulated in a tiny fat bubble and delivered to the body’s lymph node cells. There, cells protein making machinery follow the genetic instructions to build the coronavirus spike protein. Immune cells interact with the spike to muster a protective response.

Questions have also circulated about the vaccine’s ingredients, especially following the reports of rare allergic reactions. Moore explained that the vaccine contains the synthetic messenger RNA and a fat bubble. It does not contain many ingredients commonly found in other vaccines, such as preservatives or adjuvants, which are used to make vaccines work better and is not manufactured in human or animal cells. Moderna’s vaccine was shown to be 94 percent effective in its large clinical trial; Pfizer-BioNTech’s vaccine was 95 percent effective. The efficacy was similar across age, gender and racial groups.

In Moderna’s trial, 30,000 people were randomly assigned to receive either two shots of a vaccine given four weeks apart, or two saline shots. Neither the participants nor the people running the trial knew who was in which group. Investigators then waited as people were exposed to coronavirus in their daily lives, to see if there were more cases of covid-19 in the group that did not receive the real vaccine. They counted cases starting two weeks after the second dose, to measure how well the vaccine protected participants after the immune system had mustered a full response.

There were 196 cases in the trial, all but 11 of them were in the group that received the placebo shots. There were 30 cases of severe covid-19 and one death from covid-19 in the trial, all in the group that received the placebo. There was a suggestion that a first dose of vaccine afforded some protection from the virus, but some key information is lacking.
One of the main questions debated by the panel was what to do about the trial once a vaccine is authorized.

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