A US Food and Drug Administration advisory committee will vote on Johnson & Johnson’s one-dose COVID-19 injection on Friday, with the panel expecting the FDA to formally approve the emergency use of the injection in one race to vaccinate as many Americans as possible in the ongoing fight against the new coronavirus.
The jab – derived from an adenovirus vector formula, unlike vaccines created by Moderna and Pfizer-BioNTech that were created using mRNA technology and have already been approved for emergency use – was found to have a “favorable safety profile” with no specific concerns identified that prevent the issuance of a USA, “said the FDA in documents published ahead of Friday’s meeting.
The candidate vaccine proved to be 66.9% effective against moderate to severe illness in a global trial two weeks after vaccination, with the company seeking authorization for use in individuals aged 18 and over.
If the committee endorses the vaccine and the FDA authorizes the injection of J&J for use in the United States, it will not significantly increase the vaccine stock immediately. Only a few million doses are expected to be ready for shipment in the first week. But J&J told Congress this week that it expects to deliver 20 million doses by the end of March and 100 million by the summer.
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Still, “once approved for emergency use, the J&J vaccine will become the third sharp arrow in our quiver to defeat this terrible virus. More production means more people will be vaccinated sooner – to mitigate transmission, contain the pandemic and reduce future deaths, “Dr. Robert Amler, dean of the School of Health Sciences and Practice at New York Medical College and former medical director of the Center for Disease Control and Prevention (CDC), recently told Fox News in an interview .
“The availability of additional vaccines should help bridge the gap between the number of people who qualify and want vaccination and the availability of the vaccine. This is great news,” added Dr. Alan Kadish, doctor and president of Touro College & University System, to Fox News.
Studies have shown that the Pfizer and Moderna vaccines are 95% effective in protecting against symptomatic COVID-19, a greater effectiveness when compared to the J&J vaccine of 66.9%. Should Americans be concerned about the vaccine they will get, especially if the J&J vaccine has reduced effectiveness?
Not really, said Amler.
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“We will examine the practical effectiveness, rather than the effectiveness reported in studies of closely monitored populations,” he suggested. “Practical effectiveness is affected by many additional real-world factors not found in the studies.”
For example, Amler said, the single dose of J&J gives an advantage over its two-dose counterpart simply because it is a single dose injection.
“Think about all the avoided 2nd dose consultations that people will not forget or lose. Think of the need for much easier refrigeration compared to extremely low temperature freezing when shipping and storing the vaccine. With these practical factors, we can consider that vaccines are practically equivalent, “he continued.
It is important to note, however, that the FDA said on Thursday that it is allowing more flexible transport and storage temperatures for the coronavirus vaccine Pfizer-BioNTech. The move allows transport and storage for two weeks from -25 degrees Celsius to -15 degrees Celsius, which is often found in freezers and pharmaceutical refrigerators.
When it comes to choosing a vaccine, if the country gets to the point where that is an option, the two experts had mixed responses, with Amler noting that “there is no need to choose” since “the FDA and CDC have indicated that no preference between the two vaccines currently approved for emergency use. “
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“I think that in the coming months, people should receive any vaccine available because they are all substantially effective. It may be that in late summer or fall, individuals will have a choice and at that point, we will have more data to determine whether a vaccine is better than the other, “added Kadish.
Finally, who should avoid the J&J vaccine, considering that it is an experimental viral vector vaccine that uses a weakened live pathogen – adenovirus in this case?
While Amler advised to wait for official recommendations after official authorization for emergency use, Kadish noted that some groups may need to avoid the J&J vaccine due to the way it was created.
“Patients with immunosuppression or perhaps those who are pregnant should not have live action [vaccine]”Kadish said. He noted, however, that the allergic reactions seen with the Moderna and Pfizer jabs” seem less common with the J&J vaccine. “
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Both experts, however, encouraged those eligible to be vaccinated as soon as possible.
“Everyone should be vaccinated as soon as the vaccine is available and they are eligible. If young people who are eligible due to underlying conditions feel constrained to line up with the elderly, they should put aside their embarrassment and get protection, ”advised Amler.
Fox News’ Kayla Rivas and the Associated Press contributed to this report.