A vial of Johnson & Johnson’s Janssen coronavirus disease (COVID-19) vaccine candidate is seen during the Phase 3 ENSEMBLE trial in undated photographs.
Johnson & Johnson | Via Reuters
The Advisory Board of the major Food and Drug Administration will vote on Friday to recommend approval. Johnson & Johnsonof COVID-19 Vaccine for emergency use. This will help pave the way for the distribution of a third preventive treatment in the United States.
A vote of approval from the Vaccines and Related Biologics Advisory Board could pave the way for US agencies to approve J & J’s vaccines for emergency use. The Commission plays a central role in approving vaccines in the United States and ensures that Shots are safe for public use. The FDA does not have to follow the Commission’s recommendations, but it does.
Under similar request by Pfizer And ModanaThe FDA approved vaccinations for these companies the day after a committee of external medical advisors endorsed an emergency use authorization. If J & J follows this pattern, a third vaccine may be approved on Saturday.
According to data compiled by Johns Hopkins University, the United States will need a series of drugs and vaccines to end a pandemic that infects more than 28.3 million Americans and kills at least 505,899 as of Thursday. Public health officials say. Unlike Pfizer and Modana vaccines, which require two doses every three to four weeks, J & J requires only one dose to facilitate the logistics of your healthcare provider. Unlike the other two vaccines, J & J’s vaccine can also be stored in the refrigerator for several months.
Here’s what you can expect:
The meeting is tentatively scheduled to run from 9 am Eastern Standard Time. Until 5:30 pm Eastern Standard Time.
Prior to voting, healthcare professionals will evaluate J & J’s clinical trial data and provide feedback on vaccines, including whether the benefits outweigh the risks of an emergency use authorization. The company is asking the FDA to approve the use of the vaccine for people over the age of 18. Pfizer is licensed for use by people over the age of 16. A small amount of data on teens was a commitment to a small number of advisory board members who voted against Pfizer’s approval.-BioNTech December vaccine.
The FDA will decide whether to clear the J & J vaccine for emergency use. In the case of Pfizer and Moderna, the final decision from the agency was made the day after the meeting.
Such approval from the FDA is not the same as full approval. This can usually take several months. J & J, like Pfizer and Moderna, submits only two months of safety data, but agencies typically take six months to fully approve.
Initially, the dose was limited.Jeff Seients, President Joe BidenCovidczar told reporters Wednesday that the federal government will ship 3-4 million doses of J & J vaccine to states, pharmacies and community health centers next week, awaiting FDA approval.
Dr. Richard Nettles, vice president of US healthcare at J & J, plans to administer 20 million doses by the end of March. Told Congressman on Tuesday. J & J has a contract with the US government to supply 100 million doses of vaccine by the end of June, and Zients said the federal government will “do as much as it can” to increase production.
The J & J vaccine has an overall 66% effectiveness in protection against Covid-19, compared to approximately 95% of the Pfizer and Moderna vaccines. Some people wonder if they should be vaccinated with J & J because of its low efficacy rate.
However, infectious disease experts point out that J & J’s results cannot be compared directly with the other two vaccines. This is because the company’s trials were conducted when it was a single dose, had many infections, and had new infectious mutations.
Dr. Anthony Fauci, Chief Medical Advisor to the White House, said Americans should take any licensed vaccine they can get. He also states that J & J’s vaccine 100% prevented virus-related hospitalizations and deaths in late-stage trials.
“More important than whether someone prevents pain or sore throat is to prevent people from getting seriously ill,” he told reporters on a phone call on January 29. “It will reduce much of the stress, and human suffering and death in this epidemic.”
An FDA report released Wednesday did not identify any particular safety concerns of the vaccine when analyzed by age, race, or comorbidities.
I had headaches, malaise, and muscle aches Some of the most common side effects Among the vaccinated people, the report said. There were also reports of nausea, fever and pain at the injection site. According to reports, there were no reports of anaphylaxis, a severe and life-threatening allergic reaction.
The report found some cases of Bell’s palsy with half of your face hanging down, but they were “balanced” with the numbers commonly found in the entire population. FDA had before Said that the condition will be monitored Note that among vaccine recipients after being flagged as a potential concern about Pfizer injections, it is not necessarily a side effect, but it is worth noting.
Medical professionals say that the side effects of vaccines are common and that injections are actually Works as intended..The· Recommended by CDC If you experience pain or discomfort after firing, talk to your doctor about taking over-the-counter medications.
— CNBC’s Noah Higgins-Dunn contributed to this report.
What you need to know before a major FDA panel vote
Source link What you need to know before a major FDA panel vote