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 to distribute a third preventive treatment in the U.S.
A favorable vote from the Vaccines and Related Biological Products Advisory Committee will likely clear the path for the U.S. agency to approve J&J’s vaccine for emergency use. The committee plays a central role in approving vaccines in the U.S., verifying the shots are safe for public use. While the FDA doesn’t have to follow the committee’s recommendation, it often does.
During similar requests by Pfizer and Moderna, the FDA authorized those companies’ vaccinations a day after the committee of outside medical advisors backed emergency use authorization. If J&J’s follows the pattern, a third vaccine could be authorized on Saturday.
Public health officials say the U.S. will need an array of drugs and vaccines to bring an end to the pandemic, which has infected more than 28.3 million Americans and killed at least 505,899 as of Thursday, according to data compiled by Johns Hopkins University. Unlike Pfizer’s and Moderna’s vaccines, which require two doses given three to four weeks apart, J&J’s requires only one dose, easing logistics for health-care providers. J&J’s vaccine can also be stored at refrigerator temperatures for months, unlike the two other vaccines.
Here’s what to expect:
1. When are they voting?
The meeting is tentatively scheduled to run from 9 a.m. ET to 5:30 p.m. ET.
Before the vote, medical experts will assess J&J’s clinical trial data and offer their opinions 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 age 18 and older. Pfizer’s was cleared for use in people at least 16 years old. The scant data in younger teens was a sticking point for the few members of the advisory committee who voted against authorizing the Pfizer-BioNTech vaccine in December.
2. What happens next?
The FDA will make a decision on whether to clear J&J’s vaccine for emergency use. In the Pfizer and Moderna cases, the final decision from the agency came a day after the meeting.
Such an authorization from the FDA isn’t the same as a full approval, which can typically take months longer. J&J, like Pfizer and Moderna, has submitted only two months of safety data, but the agency usually requires six months for full approval
3. When will I get the vaccine?
Initially, doses would be limited. Jeff Zients, President Joe Biden’s Covid czar, told reporters on Wednesday that the federal government expects to ship 3 million to 4 million doses of J&J’s vaccine next week to states, pharmacies and community health centers, pending FDA authorization.
The company expects to deliver 20 million doses by the end of March, J&J’s vice president of U.S. medical affairs, Dr. Richard Nettles, told House lawmakers on Tuesday. J&J has a deal 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 ramp up production.
4. Should I get the vaccine?
J&J’s vaccine is 66% effective overall at protecting against Covid-19 compared with about 95% for Pfizer’s and Moderna’s vaccine. Some people have questioned whether they should get J&J’s vaccine due to the lower efficacy rate.
But infectious disease experts point out that J&J’s results can’t be directly compared to the other two vaccines because it’s a single dose and the company’s trial was conducted when there were more infections as well as new, more contagious variants.
White House Chief Medical Advisor Dr. Anthony Fauci has said Americans should take whatever authorized vaccine they can get. He also notes that J&J’s vaccine prevented 100% of virus-related hospitalizations and deaths in its late-stage trial.
“The most important thing, more important than whether you prevent someone from getting aches and a sore throat, is preventing people” from getting severe disease, he told reporters on a call on Jan. 29. “That will alleviate so much of the stress and human suffering and death in this epidemic.”
5. What are the side effects?
No specific safety concerns of the vaccine were identified when analyzed by age, race and comorbidities, according to an FDA report published Wednesday.
Headaches, fatigue and muscle pain were some of the most common side effects among people who received the inoculation, the report said. There were also reports of nausea, fever and pain at the injection site. There were no reports of anaphylaxis, a severe and life-threatening allergic reaction, according to the report.
The report found some Bell’s palsy cases, a condition that causes half of your face to droop, but they were “balanced” with the number generally found in the overall population. The FDA had previously said the condition would be monitored among recipients of vaccines after it was flagged as a potential concern with Pfizer’s shots, noting that it’s not necessarily a side effect but is worth watching out for.
Medical experts say side effects for vaccines are common and actually indicate the shots are working as intended. The CDC recommends talking to a doctor about taking over-the-counter medicine if one experiences pain or discomfort after getting the shot.
—CNBC’s Noah Higgins-Dunn contributed to this report.
Source: Business - cnbc.com
