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Tuesday, January 19, 2021

FDA panel endorses Moderna’s COVID-19 vaccine

Moderna would be the second company allowed to begin inoculating the public, giving millions more Americans access to desperately needed vaccine. The first, made by Pfizer and its German partner BioNTech, received authorization last week.

By: New York Times | Updated: December 18, 2020 10:26:27 am
moderna covid vaccine, coronavirus vaccine, fda endorses moderna vaccine, pfizer vaccine, biontech vaccine, indian expressThe headquarters of the pharmaceutical firm Moderna in Cambridge, Mass., on Nov. 19, 2020. Moderna’s coronavirus vaccine has the advantage of being distributed more widely because it can be stored at normal freezer temperatures and, unlike the Pfizer-BioNTech vaccine, does not require ultracold storage. (File photo: Cody O'Loughlin/The New York Times)

Written by Denise Grady, Abby Goodnough, Carl Zimmer and Katherine J. Wu

The coronavirus vaccine made by Moderna moved closer to authorization Thursday, a significant step that would expand the reach of the nation’s vaccination campaign to rural areas and many more hospitals.

As the nation buckled from uncontrolled spread of the disease, with 3,611 deaths Wednesday setting yet another horrific record, a panel of independent experts recommended, by a vote of 20 in favor and one abstention, that the Food and Drug Administration authorize the Moderna vaccine for emergency use. The formal decision, expected Friday, would clear the way for some 5.9 million doses to be shipped around the country starting this weekend.

Moderna would be the second company allowed to begin inoculating the public, giving millions more Americans access to desperately needed vaccine. The first, made by Pfizer and its German partner BioNTech, received authorization last week.

The Moderna vaccine can be distributed more widely because it can be stored at normal freezer temperatures and, unlike the Pfizer-BioNTech vaccine, does not require ultracold storage. It also comes in much smaller batches, making it easier for hospitals in less populated areas to use quickly.

“Moderna can go to more places,” Dr. Mandy Cohen, North Carolina’s secretary of Health and Human Services, said this week. “We hope to be in all 100 counties with some amount of vaccine — small allocations at first — by the end of next week, assuming Moderna gets approved this week and we get our allocations delivered over the course of next week.”

The two vaccines, and an ambitious rollout by the federal government, states and businesses to deploy them, are the first signs of hope for an end to the pandemic that has killed more than 300,000 Americans, closed schools and businesses and left people afraid to go near friends, neighbors and relatives, especially at the height of the holiday season.

Moderna developed its vaccine in collaboration with scientists from the National Institutes of Health.

A second vaccine couldn’t come soon enough. State health officials complained this week after they learned that the second shipment of the Pfizer vaccine would be smaller than the first one, prompting questions about whether the federal government would meet its goal of giving 20 million people an initial dose of the two-shot vaccines from Pfizer and Moderna before the end of the year. The smaller shipment, which appeared to be the result of a scheduling hiccup, ignited tensions between Pfizer and the federal government, who are negotiating over how many vaccine doses Pfizer will sell to the United States in the first half of next year.

The vaccines are in short supply, and the initial batches are being given to people at high risk of infection or serious illness: front-line health care workers and the residents and staff of nursing homes and other long-term care facilities.

On Saturday, an independent panel of experts will decide whether to recommend that the Centers for Disease Control and Prevention allow distribution of the Moderna vaccine. And on Sunday, the same panel, the Advisory Committee on Immunization Practices, will decide which “priority group” should be next in line for the vaccine.

A subcommittee of the group last month proposed that it be essential workers — some 80 million teachers, law enforcement officers, bus drivers, restaurant workers and others whose jobs involve close contact with other people. Each state would then decide which essential workers to prioritize, as there will not be nearly enough vaccine in the short term to cover them all.

The subcommittee said next in line should be people 65 and older, as well as people with conditions that put them at high risk for COVID, like diabetes or obesity. It will be up to the larger group to make a final decision Sunday, which the CDC’s director, Dr. Robert Redfield, will have to approve.

At the meeting Thursday, the FDA’s expert panel heard from Moderna, agency scientists and the public. In large clinical trials, both vaccines were about 95% effective at preventing COVID-19, and Moderna’s vaccine offered persuasive evidence that it could prevent severe cases of the disease, which is crucial for keeping people out of the hospital and reducing deaths.

Dr. Rachel Zhang, a researcher in the FDA’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.

“For maximum protection, both doses should be given,” Dr. Tal Zaks, the chief medical officer at Moderna, said at the meeting.

The panel grappled with questions about the potential for allergic reactions after a few cases occurred among people who received the first doses of the Pfizer-BioNTech vaccine. The Pfizer-BioNTech shots have been linked to three cases of a severe and potentially life-threatening reaction, anaphylaxis — two in Britain, and one in the United States, in a health care worker in Alaska. A second person at the same Alaska hospital also had a serious allergic reaction, although not anaphylaxis. All have recovered or are recovering.

Neither Moderna nor Pfizer-BioNTech reported serious problems with allergic reactions during their clinical studies, but when drugs or vaccines move out of trials and into broader distribution, rare side effects can emerge.

The two vaccines are similar but not identical. Both consist of genetic material, mRNA, encased in a bubble of lipids. The exact composition is not the same, so it is not clear that an allergic reaction to one means the same thing would occur with the other. But the possibility is a concern.

Anaphylactic reactions to vaccines in the United States have been rare, with fewer than 1 in 1 million cases per year. At the meeting Thursday, Dr. Doran Fink of the FDA said that the agency and the CDC were investigating the allergic reactions.

“We anticipate that there may be additional reports, which we will rapidly investigate,” Fink said, adding that robust surveillance systems were in place to detect these rare cases.

He said there was not enough information to tell if an ingredient in the vaccines had caused the allergic reactions.

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 during the meeting Thursday. 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.

Other side effects — fever, chills, fatigue, headache, muscle and joint pain — are much more common after getting the Moderna vaccine, especially after the second shot. Although the reported side effects are not dangerous they can be unpleasant, lasting one to three days. Doctors say the symptoms are comparable to those experienced by many people after getting Shingrix, the vaccine to prevent shingles. People should be prepared to feel under the weather for a day or two after each shot, they said, and may need to take a day off work.

Moderna’s study found that 91.6% of recipients had sore arms, 68.5% had fatigue, 63% had headaches, 59.6% had muscle pain, 44.8% had joint pain and 43.4% had chills. Some participants also had swollen lymph nodes in the armpit on the side where they received the injection.

Company scientists emphasized that the vaccine does not alter a person’s genes or interact with DNA and that the mRNA is quickly broken down and does not linger long in the body.

Both the Moderna and Pfizer-BioNTech studies reported a small number of cases of a temporary facial paralysis called Bell’s palsy. Moderna found three cases in the vaccine group and one in the placebo group, and Pfizer had four cases, all in the vaccine group. FDA reviewers did not think the disorder was related to the vaccine. On Thursday, Moderna said the company would monitor for the condition.

Shipping of the vaccine will be managed by the Trump administration’s Operation Warp Speed, but each state will decide where its doses go. Tennessee, for example, plans to disperse most of its anticipated allocation of 115,000 initial doses next week among all 195 of its local health departments, which will inoculate first responders, and to every hospital in the state that did not receive a Pfizer shipment this week.

In Kentucky, Gov. Andy Beshear told reporters that he expected close to 80,000 doses of the Moderna vaccine in the state’s initial shipment, adding, “We’re going to ensure we have some allocation for every acute care hospital across the commonwealth.”

And in Massachusetts, Gov. Charlie Baker said Tuesday that 110,000 of the state’s expected 120,000 Moderna doses would go to smaller hospitals and outpatient clinics, including community health centers.

Some states will also be handing over part of their initial Moderna allocation to CVS and Walgreens, which have contracts with the federal government to immunize residents and staff members in nursing homes starting next week.

Dr. Jasmine Marcelin, an infectious disease physician at the University of Nebraska Medical Center, was one of several clinicians who called into the FDA panel’s meeting. She mentioned the disproportionate effect of the pandemic on people of color and urged her colleagues to listen to their concerns and include trusted professionals from their communities. “The health care profession has previously betrayed these communities through centuries of structural racism,” she said.

Iletta Norris, a certified medical assistant at the Medical University of South Carolina, said she planned to get vaccinated — but would like to wait about six months. “I just want to see a little more research done,” Norris said.

Living at home with her parents and siblings, Norris said she and her family were a little nervous about how well the side effects of the vaccine had been documented and would feel more comfortable receiving the shots later.

But once Norris is vaccinated, she said, “I will be a spokesperson. I will let everyone know about my positive experience.”

Moderna has requested authorization to vaccinate adults, based on its clinical trial in 30,000 people 18 and older. Pfizer included some younger volunteers in its study and was authorized for use in people 16 and older.

But neither vaccine was tested in pregnant or breastfeeding women. Many vaccines and drugs are studied in other groups before their safety is assessed in pregnant women. But researchers did not observe any harmful effects of the Moderna vaccine in 13 women who became pregnant during the course of the trial.

An estimated 330,000 health care workers are expected to be pregnant or breastfeeding as the vaccines are rolled out. With no evidence of harm, and given the high risk of COVID-19 in these women, the FDA did not exclude pregnant or breastfeeding women from its authorization of the vaccines.

An advisory group to the CDC recommended last week that women who are either pregnant or breastfeeding, or in the planning stages, to consult their doctors before choosing to take the Pfizer vaccine. The committee is expected to make a similar recommendation for the Moderna vaccine this weekend.

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