What You Need To Know Before FDA’s Key Panel Vote


Vials of Johnson & Johnson’s Janssen coronavirus disease (COVID-19) vaccine candidate are seen during the ENSEMBLE phase 3 trial in an undated photograph.

Johnson & Johnson | via Reuters

A key Food and Drug Administration advisory panel is scheduled to vote Friday on whether to recommend approval of Johnson & Johnson’s Covid-19 vaccine for emergency use, which would help pave the way for distributing a third preventive treatment. In the USA.

A favorable vote from the Advisory Committee on Vaccines and Related Biologics will likely clear the way for the US agency to approve the J&J vaccine for emergency use. The committee plays a central role in the approval of vaccines in the United States, verifying that the injections are safe for public use. While the FDA does not have to follow the committee’s recommendation, it often does.

During similar requests from Pfizer and Moderna, the FDA cleared those companies’ vaccines a day after the committee of external medical advisers endorsed the emergency use authorization. If J & J’s follows the pattern, a third shot could be authorized on Saturday.

Public health officials say the U.S. will need a variety of drugs and vaccines to end the pandemic, which has infected more than 28.3 million Americans and killed at least 505,899 as of Thursday, data shows. compiled by Johns Hopkins University. Unlike the Pfizer and Moderna vaccines, which require two doses over three to four weeks, J&J only requires one dose, making logistics easier for healthcare providers. The J&J vaccine can also be stored at refrigerator temperature for months, unlike the other two vaccines.

This is what to expect:

1. When are you going to vote?

The meeting is tentatively scheduled from 9 am ET to 5:30 pm ET.

Before the vote, medical experts will evaluate data from J&J clinical trials and offer their opinions on the vaccine, even if the benefits outweigh the risks of an emergency use authorization. The company is asking the FDA to approve the vaccine for use in people 18 years of age and older. Pfizer’s is licensed for use by persons 16 years of age or older. The paucity of data in younger teens was a sticking point for the few advisory committee members who voted against authorizing the Pfizer-BioNTech vaccine in December.

2. What happens next?

The FDA will make a decision on the approval of J & J’s vaccine for emergency use. In the Pfizer and Moderna cases, the agency’s final decision was made one day after the meeting.

This FDA clearance is not the same as a full approval, which can usually take months longer. J&J, like Pfizer and Moderna, has submitted only two months of safety data, but the agency generally requires six months for full approval.

3. When will I get the vaccine?

Initially, the doses would be limited. Jeff Zients, President Joe Biden’s Covid Czar, told reporters Wednesday that the federal government expects to ship 3-4 million doses of the J&J vaccine next week to states, pharmacies, and community health centers. pending FDA clearance.

The company expects to deliver 20 million doses by the end of March, J&J Vice President for US Medical Affairs Dr. Richard Nettles told House lawmakers on Tuesday. J&J has an agreement with the US government to supply 100 million doses of its vaccine by the end of June, and Zients said the federal government will do “everything possible” with the company to increase production.

4. Should I get the vaccine?

The J&J vaccine is 66% effective overall in protecting against Covid-19 compared to about 95% of the Pfizer and Moderna vaccines. Some people have wondered if they should get the J&J vaccine because of the lower efficacy rate.

But infectious disease experts note that J & J’s results cannot be directly compared to the other two vaccines because it is a single dose and the company’s trial was conducted when there were more infections and new, more contagious variants.

The White House’s chief medical adviser, Dr. Anthony Fauci, has said that Americans should take any licensed vaccine they can get. It also notes that J & J’s vaccine prevented 100% of virus-related hospitalizations and deaths in its late-stage trial.

“Most importantly, more important than if you prevent someone from getting a sore and sore throat, is to prevent people” from contracting a serious illness, he told reporters in a call on January 29. “That will alleviate much of the stress. and human suffering and death in this epidemic. “

5. What are the side effects?

No specific vaccine safety concerns were identified when analyzed by age, race and comorbidities, according to an FDA report released Wednesday.

Headaches, fatigue and muscle pain were some of the most common side effects among people who received the vaccine, according to the report. There were also reports of nausea, fever, and pain at the injection site. There were no reports of anaphylaxis, a serious and life-threatening allergic reaction, according to the report.

The report found some cases of Bell’s palsy, a condition that causes half of the face to sag, but they were “balanced” with the number generally found in the general population. The FDA had previously said that the condition would be monitored among vaccine recipients after it was flagged as a potential concern with Pfizer injections, noting that it is not necessarily a side effect, but is worth keeping an eye on.

Medical experts say that the side effects of vaccines are common and actually indicate that the injections are working as expected. The CDC recommends talking to a doctor about taking over-the-counter medications if one experiences pain or discomfort after receiving the injection.

—Noah Higgins-Dunn of CNBC contributed to this report.

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