What you need to know before the FDA key court vote

A key Food and Drug Administration advisory committee is scheduled to vote Friday on whether the approval of Johnson & Johnson’s Covid-19 vaccine for emergency use is recommended, which would help pave the way for distribute a third preventive treatment in the US

A favorable vote by the Advisory Committee on Vaccines and Related Biological Products is likely to pave the way for the U.S. agency to approve the J&J vaccine for emergency use. The committee plays a central role in approving vaccines in the U.S., in verifying that the shots are safe for public use. While the FDA should not follow the committee’s recommendation, it often does.

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

Public health officials say the U.S. will need a large amount 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, according to data collected by Johns Hopkins University. Unlike Pfizer and Moderna vaccines, which require two doses administered three to four weeks apart, J&J vaccines require only one dose, facilitating logistics for healthcare providers. The J&J vaccine can also be stored at refrigerator temperature for months, unlike the other two vaccines.

Here’s what to expect:

The meeting is scheduled to take place provisionally from 9 a.m. to 5:30 p.m. (ET).

Prior to voting, medical experts will evaluate data from J&J clinical trials and offer their views on the vaccine, including whether the benefits outweigh the risks for an emergency use authorization. The company is asking the FDA to approve the use of the vaccine in people over 18 years of age. Pfizer was authorized for use by persons at least 16 years of age. The few data from younger teens were a stalemate for the few advisory committee members who voted against authorizing the Pfizer-BioNTech vaccine in December.

The FDA will make a decision on whether to remove the J&J vaccine for emergency use. In the Pfizer and Moderna cases, the agency’s final decision came a day after the meeting.

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

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

The company expects to deliver 20 million doses by the end of March, J&J’s U.S. vice president of medical affairs, Dr. Richard Nettles. J&J has an agreement with the U.S. government to supply 100 million doses of its vaccine by the end of June and Zients said the federal government will do “everything we can” with the company to increase production.

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

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

Dr. Anthony Fauci, chief medical adviser to the White House, has said Americans should take any authorized vaccine they can get. He also notes that the J&J vaccine prevented 100% of hospitalizations and virus-related deaths in its final stage.

“The most important thing, more important than preventing someone from having aches and sore throats, is to prevent people from ‘suffering from serious illnesses,'” he told reporters in a call on Jan. 29. ” This will alleviate the stress and suffering and death of humans in this epidemic. “

According to an FDA report released Wednesday, no specific vaccine safety issues were identified when analyzed for age, race, and comorbidities.

Headaches, fatigue, and muscle aches were some of the most common side effects among people who received the inoculation, according to the report. Nausea, fever, and pain at the injection site were also reported. According to the report, no anaphylaxis was reported, a serious and life-threatening allergic reaction.

The report found some cases of Bell’s palsy, a condition that drops half of the face, but they were “balanced” with the number usually found in the general population. The FDA had previously said the disease would be controlled among vaccine recipients after marking it as a possible concern for Pfizer traits, noting that it is not necessarily a side effect, but worth monitoring for.

Medical experts say the side effects of vaccines are common and indicate that the shots work as intended. The CDC recommends talking to a doctor about taking over-the-counter medications if someone experiences pain or discomfort after receiving the vaccine.

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