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Johnson & Johnson Covid-19 vaccine: FDA consultant considers recommending a vaccine



This vaccine is the third vaccine being considered in the US market and will be the first single-dose Covid-19 vaccine here. Like the early Covid-19 vaccine, it was developed and tested at an alarming rate, condensing the months that might take before the pandemic into months.

However, the answer will only happen if you are authorized. The White House said Monday that if approved, it has no plans to distribute the vaccine. There is total ambiguity as to how many doses can be obtained immediately, and it is not clear where these doses will go.

The Biden administration said last week that if authorized, there could be millions of units of usable doses in the next few weeks. On Tuesday, Johnson & Johnson’s Dr. Richard Nettles will say that the program “will begin shipping as soon as emergency use authorization is obtained, and deliver enough single-dose vaccines by the end of March to allow more than 20 million Americans can be vaccinated.”
; Prepare to speak on the Subcommittee of the House Energy and Commerce Committee.

Despite this, clinical trial researchers are still confident that Johnson & Johnson vaccines will be approved as quickly as Pfizer/BioNTech and Moderna Covid-19 vaccines.

One of the main investigators of the J&J trial, Dr. Pat Flynn of St. Jude Children’s Research Hospital in Memphis, said: “We want it to be faster or even faster.”

Johnson & Johnson formally applied to the FDA for emergency use authorization on February 4. Adding a third vaccine to the mix-especially one that only requires one dose-will increase supply and flexibility for US vaccination efforts.
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Dr. Jeff Carson of the trial co-hosted by Rutgers Biomedical and Health Sciences said: “It seems to be very effective in preventing the most serious forms of disease.” His trial department is Johnson & Johnson’s second largest. Department, there are more than 800 volunteers. “We haven’t seen any side effects data from the company, but I don’t think this is a big problem at all.”

Carson said: “I hope it will be approved, of course we need it.”

Carson said he is eager to see more data about the vaccine. The agency stated that detailed information regarding submissions to the FDA should be made available online no later than Wednesday.

How is the vaccine different

On Friday, the FDA committee will study any potential safety issues. For example, for Moderna and Pfizer vaccines, the committee raised questions about some cases of severe allergic reactions to these vaccines. Serious adverse reactions are extremely rare.

The committee will also study the effectiveness of the vaccine. According to Johnson & Johnson’s mid-term results, data show that the vaccine is 66% effective in preventing moderate and severe diseases. In all the areas tested, the vaccine has an overall effective rate of 85% in preventing hospitalization and 100% in preventing death.
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Its efficacy for moderate to severe diseases varies from country to country: 72% in the United States, 66% in Latin America, and 57% in South Africa. Measure from one month after shooting.

Experts say the difference in regional effectiveness may be partly due to the large number of variants in circulation.

In the South African branch of clinical trials, most cases are caused by a variant called B.1.351, which is more easily spread and carries variants that make it less sensitive to antibody immune responses-including vaccination Vaccine tips.

The Pfizer vaccine showed 95% of the symptoms to prevent Covid infection after a person received two doses, while the Moderna vaccine was 94.1% effective, but scientists said it is unfair to compare these vaccines because they did not test each other.

Pfizer and Moderna vaccines, which have almost the same efficacy, were tested almost simultaneously. A few months later, when more variants were in circulation, the Johnson & Johnson vaccine was tested.

Carson said: “I think in the end, we don’t know if one person is better than the other.”

The vaccine-despite the variants-is still good news

Dr. Aditya Guar, a researcher from the St. Jude branch of the study, said that people need to understand the effects of Johnson & Johnson vaccines very well.

Guar said: “It is important to prevent the outcome of hospitalization and death. For this reason, it is complete.” “One dose of the vaccine is effective and effective.”

Carson said patients and friends have been asking him if he should take the Johnson & Johnson vaccine when it is available.

Carson said: “My advice to all my patients and all my friends is to get the first vaccine you can get. This is the most important thing to be protected.”

All vaccine manufacturers are studying whether booster doses can provide better protection against coronavirus mutations. Johnson & Johnson is also conducting an ongoing late-stage trial that tested a two-dose vaccination regimen. The company expects to achieve these results in the second half of 2021.

What happened next

Johnson & Johnson expressed confidence in its single-dose vaccine candidate.

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A Johnson & Johnson spokesperson said in an email to CNN: “The company’s EUA submission is based on the main efficacy and safety data of the ENSEMBLE Phase 3 clinical trial, indicating that the single-dose vaccine used in the study can meet all major and major secondary The end point.” “The World Health Organization believes that a dose of vaccine is the best option in a pandemic situation, increasing access, distribution and compliance.”

If the committee recommends emergency use authorization for Johnson & Johnson vaccine, then the FDA will next decide whether to accept the recommendation. It usually does this, and it can make decisions almost immediately like Pfizer and Moderna vaccines.

Next, the US Centers for Disease Control and Prevention’s Immunization Practice Advisory Committee will meet to discuss whether Americans should be vaccinated. If so, the committee will help determine who should be vaccinated first. The committee is scheduled to hold emergency meetings on February 28 and March 1.
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For Pfizer, the process took more than three weeks. For Moderna, there are only a little more than two.

Vaccination may start soon. It is expected that Johnson & Johnson’s vaccine will be easier to dispense, requiring only one injection.

Dr. Philip Grant, the lead researcher of the Johnson & Johnson trial at Stanford University Medical Center, said: “If you consider the population, the Johnson & Johnson vaccine can provide more protection.” “You know that if you give 10 Johnson & Johnson vaccines, you can protect 10 people. Pfizer Or Moderna’s 10 vaccines can protect 5 people. You know, even in the short term, it will play a huge role in the United States.”

Push for more doses

A week after delivery, the pharmacy made a familiar request:

However, there are still questions about how much to dose. When asked, the company will not directly provide specific weekly production figures. The US government has ordered the delivery of 100 million doses in June, and Johnson & Johnson told CNN that it can deliver on this promise.

The company has been working hard to increase production, and the Biden government has been paying close attention to the manufacturing process, saying it is “doing everything it can” to speed up delivery.

Johnson & Johnson Nettle’s comment said: “The production of our vaccine is a very complex process that requires very special functions and experience.” “As a result, there is a timetable for expanding manufacturing output and speeding up the production of COVID-19 vaccines. Are inherently significant challenges.”

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and Chief Medical Advisor to the White House, said Monday that more doses will be available in the future.

Fauci said: “The EUA will not have many doses immediately, but as we enter the contract system for a few months, that is, the dose of 100 million doses, this will accelerate.”

It is unclear who can buy the vaccine. Andy Slavitt, a senior adviser to the White House Coronavirus Response Team, said on Monday that the federal government will wait for the FDA’s decision and the guidance of the CDC committee.

Fauci said the FDA may find information in the trial data, which will suggest the best distribution strategy.

Fauci said: “The data may imply how to use it most appropriately and efficiently. When we discover this, the allocation policy will become more scientific.”


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