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COVID-19: F.D.A. Expert Panel Approves Johnson & Johnson’s Vaccine

Johnson & Johnson’s Vaccine
COVID-19 Vaccine

Earlier today (Feb. 26), the U.S. vaccine advisory panel of the Food and Drug Administration (FDA) approved Johnson & Johnson’s Covid-19 vaccine for critical use unanimously. Although the FDA does not require to obey the recommendations of the committee, it usually does.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) had to determine whether the benefits outweigh the risks for people 18 and older. With 22 affirmative votes, the bill passed unanimously. 

After the vote, Archana Chatterjee, MD, Ph.D., a member of VRBPAC, a pediatric infectious disease specialist and dean of Chicago Medical School, said it is good to bear in mind that the world is still in a pandemic, considering concerns posed during today’s debate. “This vaccine will help to fulfill existing needs.”

Members of the committee also think that in the race to stop the spread of the virus and the mutations, this vaccine can be beneficial. Furthermore, Johnson & Johnson’s vaccine is better than the previous ones. Therefore, it will set the bar high. Besides, they think that more data, in this case, can help in clinical use.

However, after reviews and discussions on the vaccine at the end of the day, it got 22-0 votes. All 22 members of the committee agree that the vaccine is effective. Moreover, this vaccine is safe for the public to use, especially 18 years and older. 

After Pfizer-BioNTech and Moderna, this is the third vaccine that the health experts suggest. However, unlike the two previous vaccines, J&J’s is a single shot, which can be shipped and stored under refrigerated, not frozen conditions, as required by the other two.

J&J’s: A Single Shot Vaccine

On January 29, Johnson & Johnson’s Janssen Pharmaceutical Companies revealed that its one-shot COVID-19 vaccine is 66 percent effective in defending against disease. But, 85 percent is effective in preventing serious disease. These findings may make it particularly useful in vaccinating poor health care systems in parts of the world.

In contrast, the two vaccines that have already been approved in the United States -one is from Moderna, and another one is from Pfizer-BioNTech – require two doses separated by three to four weeks. Unlike Moderna’s and Pfizer-BioNTech’s vaccines which must be frozen, Janssen’s vaccines can be contained in standard refrigerators.

Additionally, after two doses of the shots from Moderna’s and Pfizer-BioNTech’s vaccines, it is 94-95 percent effective in protecting against COVID-19. A new vaccine platform, mRNA, suggests that Janssen’s vaccine follows a more conventional approach. It introduces a SARS-CoV-2 gene to the human immune system. Which then learns to protect the body against COVID-19 using a harmless human cold virus. (The virus that causes COVID-19 is SARS-CoV-2).

As per the World Health Organization (WHO), a one-shot vaccine is the most convenient option. In pandemic settings, it can enhance access, distribution, and compliance as well, says J&J Chief Science Officer Dr. Paul Stoffels in a statement. Efficacy of 85 percent in avoiding extreme COVID-19 disease and COVID-19-related medical treatments could potentially shield millions of people. It can prevent COVID-19’s serious and fatal consequences.

The single dose played a part in the decision of the committee. Logistically, it is far better to vaccinate individuals one time than to expect them to return for a second dose. “This was a relatively easy decision,” says Dr. Eric Rubin, editor in chief of the New England Journal of Medicine.

History of the Vaccine

The J&J findings came only days after Maryland-based Novavax revealed that its vaccine was nearly 90% successful in protecting against COVID-19 disease in a Phase 3 trial. Such findings are particularly promising considering the study involving 15,000 people in the United Kingdom, where a new mutant form of SARS-CoV-2 is rapidly spreading.

High efficacy indicates that people who have been vaccinated with the Novavax shot, which is based on another validated SARS-CoV-2 injection technology to induce an immune response, should expect strong safety against the new version.

A single dose was 66 percent effective in protecting people from moderate to serious COVID-19 disease in Janssen’s primary vaccine trial, involving nearly 44,000 people. However, it was somewhat less effective in defending against new strains of the virus, with a safety rate of about 57 percent against one discovered in South Africa. Still, the defense met the 50 percent effectiveness threshold set by the FDA to grant authorization for emergency use.

Committee members posed concerns about how much of the immune response to the COVID-19 virus could be blunted by a response installed as a delivery vessel against the weakened cold virus, a well-known impact of this vaccine platform. Since the body becomes tolerant to the weakened virus vector, such vaccinations may be less successful when boosted with additional shots.

Dr. Johan Van Hoof, Managing Director of Janssen Vaccines and Prevention, however, noted that studies using similar technologies on the company’s HIV vaccine candidate showed that individuals boosted with additional shots years after the first managed to develop good immune responses that did not seem to be strongly influenced by the weakened virus vector.

Complications

While the vaccine is effective, there were certain questions as well as complications from this new vaccine. Many committee members challenged the company’s results. This showed that the vaccine produced a slightly lower response in antiviral antibody levels in people over 60. Especially those with underlying health conditions, a community especially vulnerable to COVID-19.

Nevertheless, Janssen’s studies show that these individuals also didn’t experience serious COVID-19 disease or require hospitalization compared to people consuming the placebo. The vaccine was 85% effective in shielding people from serious illnesses. Out of the 44,000 individuals, there were only 21 deaths overall. Five occurred among those who got the vaccine and the rest among the placebo community. None of the deaths are from the vaccine.

In their analysis, the FDA scientists noticed that some study participants had significant side effects. For instance, tinnitus (ringing in the ears), clotting, and hives may be attributable to the vaccine and worth additional follow-up. But, these were unusual, and the vaccine was generally effective, with most people experiencing only mild to moderate side effects. For example, headaches, chills, and muscle aches are the major side effects.

Is it a One-Shot Vaccine?

Another issue that came up repeatedly during the day-long debate was if Janssen’s vaccine is truly a one-shot vaccine. Or whether it, like the Pfizer-BioNTech and Moderna vaccines, needs a two-shot procedure. The original data by the company came from a trial in which participants received just one dose of the vaccine. However, the company is currently undertaking another study of 30,000 people.

In this study, people will receive two doses of the vaccine. That is to see whether adding a second booster will improve immune responses any further. If the two doses appear to be more effective, it will raise many questions. Such as what to do about people who might receive a single dose shot in the coming weeks or months? And should they approve the one-dose vaccine?

Van Hoof suggests that considering the severity of the current situation, this is a point worth putting off for later. He says that their single-dose research has given effective results against serious illnesses, hospitalizations, and deaths. Besides, the protocol is extremely well-positioned to be used during an outbreak, he said.

Conclusion

To sum up, in clinical trials, Johnson & Johnson’s Vaccine formulation worked well. Particularly against serious illnesses and hospitalizations, even though it did not meet the sky-high efficacy rates of the first two Pfizer-BioNTech and Moderna vaccines. Therefore, the council, consisting of qualified experts on infectious diseases, statisticians, and epidemiologists, voted unanimously to approve the vaccine. They think that it is better to have this vaccine in a situation like now as its benefits outweigh the side effects.

Written by HealthRadar360

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