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What you need to know before voting for FDA key groups



During the third phase of the ENSEMBLE trial, a vial of Johnson & Johnson’s Jansen Coronavirus Disease (COVID-19) vaccine candidate was seen in an undated photo.

Johnson & Johnson | Via Reuters

An important advisory panel from the U.S. Food and Drug Administration is scheduled to vote on Friday whether to recommend approval of Johnson & Johnson’s Covid-1

9 vaccine for emergency use, which will pave the way for the distribution of a third preventive treatment in the United States.

The approval of the Vaccines and Related Biological Products Advisory Committee may clear the way for US agencies to approve Johnson & Johnson’s vaccines for emergency use. The committee plays a central role in the approval of vaccines in the United States to ensure that injected vaccines are safe for public use. Although the FDA does not have to follow the committee’s recommendations, it usually does.

When Pfizer and Moderna made similar requests, the FDA approved the vaccinations of these companies on the second day after the external medical advisory committee supported the emergency use authorization. If Johnson & Johnson follows this model, it could approve a third vaccine on Saturday.

Public health officials said that according to data compiled by Johns Hopkins University, as of Thursday, more than 28.3 million Americans had been infected with the virus and killed at least 505,899 people. The United States will A series of drugs and vaccines are needed to end this pandemic. The vaccines from Pfizer and Moderna require two doses three to four weeks apart, while Johnson & Johnson’s vaccine requires only one dose, which simplifies the logistics of medical service providers. Unlike the other two vaccines, Johnson’s vaccine can also be stored at refrigerator temperature for several months.

This is expected:

1. When do they vote?

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

Before the vote, medical experts will evaluate Johnson & Johnson’s clinical trial data and comment on the vaccine, including whether its benefits exceed the risks of emergency use authorization. The company requires the FDA to approve the use of the vaccine in people over 18 years of age. Pfizer has been approved for use in people who are at least 16 years old. The few members of the advisory committee voted against approval of the Pfizer-BioNTech vaccine in December, which is the crux of the lack of data for teenagers.

2. What will happen next?

The FDA will decide whether to clear Johnson & Johnson’s emergency vaccine. In the Pfizer and Moderna case, the agency’s final decision was made the day after the meeting.

This FDA authorization is not the same as a full approval, and it can usually take several months.Like Pfizer and Moderna, Johnson & Johnson only submitted two months of safety data, but it usually takes six months for the agency to obtain full approval

3. When can I get the vaccine?

Initially, the dosage will be limited. President Joe Biden’s Jeff Coient czar (Jeff Coient czar) Jeff Zients told reporters on Wednesday that the federal government expects to ship 3 million to 4 million doses of Johnson & Johnson’s vaccine to the states next week. , Pharmacies and community health centers, waiting for FDA approval.

Johnson & Johnson’s vice president of US medical affairs, Dr. Richard Nettles, told House of Representatives on Tuesday that the company expects to provide 20 million doses by the end of March. Johnson & Johnson has reached an agreement with the US government to provide 100 million doses of vaccine by the end of June. Zients said the federal government will “do everything possible” to cooperate with the company to increase production.

4. Should I be vaccinated?

Johnson & Johnson’s vaccines are 66% effective in preventing Covid-19 overall, while Pfizer and Moderna’s vaccines are about 95% effective. Some people question whether the Johnson & Johnson vaccine should be taken due to its low efficacy.

But infectious disease experts pointed out that J&J’s results cannot be directly compared with the other two vaccines, because J&J is a single-dose vaccine, and the company’s trials are conducted when there are more infections and new, more infectious variants. of.

The chief medical adviser to the White House, Dr. Anthony Fauci, said that Americans should take any authorized vaccine they can get. He also pointed out that Johnson & Johnson’s vaccine prevented 100% of virus-related hospitalizations and deaths in its later trials.

He told reporters in a phone call on January 29: “The most important thing is to prevent people from getting serious diseases. This is more important than preventing people from feeling pain and sore throat. This will relieve a lot of stress.” And human suffering and death in this epidemic. “

5. What are the side effects?

According to the FDA report released on Wednesday, when analyzing by age, race, and comorbidities, no specific safety issues of the vaccine were found.

The report states that headache, fatigue and muscle pain are the most common side effects among vaccinated people. There are also reports of nausea, fever and pain at the injection site. According to the report, there are no reports of allergic reactions. Allergic reactions are serious and life-threatening allergic reactions.

The report found some cases of Bell’s palsy, which can cause half of your face to sag, but they are “balanced” with the number that is prevalent in the general population. The FDA has previously stated that after marking this situation as a potential risk of Pfizer injection, it will monitor the disease among vaccine recipients, and pointed out that this is not necessarily a side effect, but it is worthy of attention.

Medical experts say that the side effects of the vaccine are very common, which in fact shows that the injection was carried out as expected. The Centers for Disease Control and Prevention (CDC) recommends that you discuss taking over-the-counter medications with your doctor if you feel pain or discomfort after shooting.

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


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