Johnson & Johnson COVID-19 vaccine on the way to the FDA committee vote: What the experts say

A U.S. Food and Drug Administration advisory committee will vote on Johnson & Johnson’s COVID-19 sting with one dose on Friday, and the panel is expected to recommend that the FDA approve the emergency shot in a race to get as many Americans into it. possibly in the ongoing battle against the new coronavirus.

In contrast to the vaccines created by Moderna and Pfizer-BioNTech, which were created using mRNA technology and have already seen emergency approval, it was found that a “favorable safety profile without specific problems was identified that the issuance of exclude an EUA, ‘the FDA said in documents released ahead of Friday’s meeting.

The candidate for vaccination was 66.9% effective against moderate to severe diseases in a worldwide trial two weeks after vaccination. The company has requested permission for use in individuals 18 years and older.

If the committee endorses the vaccine, and the FDA approves the J&J survey for U.S. use, it will not immediately significantly increase the vaccine supply. It is expected that only a few million doses will be ready for dispatch in the first week. But J&J told Congress this week that he expects to give 20 million doses by the end of March and 100 million by the summer.

FDA MAKES PFIZER COVID-19 VACCINE SHIPPING, STORAGE TEMPERATURE

Yet, “once the J&J vaccine is approved for emergency use, it will become the third sharp arrow in our quiver to defeat this horrific virus. More production means more people will be vaccinated sooner – to reduce transmission, the pandemic to suppress and reduce future deaths, “Drs. Robert Amler, dean of the School of Health Sciences and Practice at New York Medical College and former head of the Center for Disease Control and Prevention (CDC), said in a recent interview with Fox News.

“The availability of additional vaccines should help address the gap between the number of people who are eligible and want vaccination, and the availability of vaccines. This is good news,” said Dr. Alan Kadish, MD and president of the Touro College & University System, added to Fox News.

Studies have shown that the Pfizer and Moderna vaccines are 95% effective in protecting against symptomatic COVID-19, a greater effectiveness compared to the J&J stab at 66.9%. Should Americans worry about which vaccine they get, especially if the J&J has one less effective?

Not really, Amler said.

HOW DO WE KNOW COVID-19 BOSSEINTE SAFE?

“Let’s look at practical efficiencies, rather than efficiencies reported from studies of populations that are closely monitored,” he suggested. “Practical efficiency is affected by many additional factors not found in studies.”

Amler, for example, says J & J’s single dose gives it an advantage over its two dose counterparts, simply because it’s a single dose jab.

“Think of all the appointments that 2nd doses have been avoided, that people will not forget or miss. Think of the much easier cooling need versus the extreme freezing point at low temperature when shipping and storing vaccines. With these practical factors, we can consider that the vaccinations practically equivalent, ‘he continued.

However, it is worth noting that the FDA said Thursday that it allows for more flexible shipping and storage temperatures for the Pfizer BioNTech coronavirus vaccine. The change allows transport and stores it for two weeks at -25 degrees Celsius to -15 degrees Celsius, which is common in pharmaceutical freezers and refrigerators.

If the country reaches a point where it is an option, the two experts have had mixed reactions, and Amler noted that ‘there is no need to choose’, as the FDA and CDC have indicated no. preference between the two vaccines currently approved for emergency use. ‘

WHAT IS THE DIFFERENCE BETWEEN MRNA ESTABLISHMENT AND CONVENTIONAL?

“I think people should get the vaccine available in the next few months because they are all effective. It may be that individuals will have a choice by late summer or fall, and at that point we will need additional data to fast. to determine if one vaccine is better than the other, ”Kadish added.

Finally, is there anyone who should avoid the J&J jab, as it is an experimental viral vector vaccine that uses an attenuated live pathogen adenovirus in this case?

While Amler advised waiting for official recommendations after the official authorization for emergency use, Kadish noted that some groups should avoid the J&J vaccine because of the way it was created.

‘Patients who are immunocompromised or perhaps pregnant should not receive the direct action [vaccine], “said Kadish. However, he notes that the allergic reactions seen with the Moderna and Pfizer stings are less common with the J&J vaccine. “

CLICK HERE FOR FULL CORONAVIRUS COVERAGE

However, both experts urged those to be vaccinated as soon as possible.

“Everyone should be vaccinated as soon as the vaccine is available and they are eligible. If eligible young people feel uncomfortable standing with the elderly due to underlying conditions, they should look beyond their embarrassment and get the protection,” Amler said.

Fox News’ Kayla Rivas and Associated Press contributed to this report.

Source