December 7, 2022

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FDA considers the booster shot of Johnson & Johnson COVID-19 vaccine

FDA considers to lower the FDA considers the booster shot of Johnson & Johnson COVID-19 vaccine and may lower the booster shot of Pfizer and Moderna COVID-19 to at least 40 years old



 

FDA considers the booster shot of Johnson & Johnson COVID-19 vaccine and may lower the booster shot of Pfizer and Moderna COVID-19 to at least 40 years old

The single-dose Johnson & Johnson vaccine is less effective than the Pfizer and Moderna vaccines, which is what prompted the FDA to speed up the review. But the company lacks verified data on booster vaccines.

 

The U.S. Food and Drug Administration (FDA) Vaccine Critical Advisory Committee held a two-day meeting on Thursday and Friday. After intense discussions, the committee supported adults aged 18 and over who received a single dose of Johnson & Johnson vaccine at least two months apart. Get the second booster vaccine.

 

The main reason for supporting the above decision of the FDA Vaccine Committee is that the effectiveness of a single dose of Johnson & Johnson vaccine is lower than that of two doses of mRNA vaccine. The FDA does not have to comply with the decision of the Vaccine Advisory Committee, but they usually do.

 

Once the FDA approves the booster vaccine, the Centers for Disease Control and Prevention (CDC) will make the next decision to distribute the booster vaccine.

 

Peter Marks, director of the FDA’s Center for Biologics and Research, said that before Friday’s meeting, the FDA reviewed the immunogenicity data of thousands of Johnson & Johnson participants, a process that took several months to complete in the past.

 

However, many doctors accused the FDA of reviewing Johnson & Johnson’s vaccine booster too quickly. They also believe that there are still many uncertainties about Johnson’s booster vaccines, and the company lacks verified data on booster vaccines.

 

FDA medical officer Timothy Brennan (Timothy Brennan) told the advisory committee that one of the trials to verify the side effects of the Johnson & Johnson vaccine booster had only 17 participants between the ages of 18 and 55. The sample size of the trial was insufficient. He could not draw any conclusions on the data.

 

Johnson & Johnson reported that 47% of the 17 participants who received the booster vaccine reported headaches, 26% reported fatigue, and 21% reported muscle pain. These side effects are milder than the side effects of the first dose of vaccination.

 

Some committee members questioned what allowed Johnson & Johnson to submit unverified data to the FDA Vaccine Advisory Committee. In this regard, the chairman of the committee, Arnold Monto (Arnold Monto) explained that the single-dose Johnson & Johnson vaccine is less effective than the Pfizer and Moderna vaccines, which prompted them to speed up the review.

 

“There is an urgent need for public health.” Monto said, “The effectiveness of Johnson & Johnson vaccines is generally lower than that of mRNA vaccines, so there is an urgent need to take measures.”

 

According to the latest data released by Johnson & Johnson on September 21, after the second dose of Johnson & Johnson booster vaccination, it can produce a protection rate similar to that of the mRNA vaccine, and the protection rate against symptomatic infections has increased to 94%. Johnson & Johnson Vaccine has previously shown in clinical trials in the United States that the protection rate of single-dose vaccination is 72%, which is much lower than Moderna and Pfizer’s mRNA vaccines.

 

Some experts believe that if the effectiveness of a single-dose vaccine is not enough, then the standard should be adjusted accordingly. Eric Rubin, an expert on the advisory committee, said: “I strongly recommend that people who meet the requirements get a second dose of Johnson & Johnson vaccine.”

 

The FDA is also considering broadening the age of the population receiving the third dose of mRNA vaccine to 40 years and above. Last month, the FDA approved a third dose of Pfizer mRNA vaccine booster for people 65 years and older, as well as people with serious underlying diseases and high-risk groups.

 

“The reason why 40 years old is used as a boundary is that there have been reports of rare cases showing that young men vaccinated with mRNA have myocarditis.” FDA’s Max explained. He also emphasized that the data on boosters submitted by Johnson & Johnson Vaccine did not fully reflect the data on the performance of the vaccine.

 

Johnson & Johnson scientists previously stated that the durability of Johnson & Johnson vaccine antibodies is better than that of mRNA, but Max said that the data does not fully reflect this.

 

“The vaccination strategy is a process of continuous optimization. If the effectiveness of a single dose of vaccine is found to be insufficient, it is normal to consider a second dose while ensuring safety.” A disease control expert told China Business News. Express.

 

According to the results of a booster vaccine published by the National Institutes of Health (NIH) this week, the use of a different type of vaccine as a booster will produce a higher antibody response compared to using the same type of vaccine as a booster.

 

The above-mentioned research has also sparked a debate about whether to vaccinate Americans who have been vaccinated against Johnson & Johnson with mRNA vaccine as a booster.

 

 

 

FDA considers to lower the booster shot of mRNA vaccine to 40 years old

(source:internet, reference only)


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