Johnson & Johnson vaccine on track for final approval in coming days
The single-dose vaccine is a 'big addition' the COVID-19 vaccine arsenal, Fox News medical contributor Dr. Marc Siegel says.
A U.S. Food and Drug Administration advisory committee on Friday is slated to vote on Johnson & Johnson’s one-dose COVID-19 jab, with the panel expected to recommend that the FDA formally grant the shot emergency use approval in a race to vaccinate as many Americans as possible in the continued fight against the novel coronavirus.
The jab — derived from an adenovirus vector formula, unlike the vaccines created by Moderna and Pfizer-BioNTech which were created using mRNA technology and have already seen emergency use approval — was found to have a "favorable safety profile with no specific concerns identified that would preclude issuance of an EUA," the FDA said in documents posted ahead of Friday's meeting.
The vaccine candidate proved to be 66.9% effective against moderate-to-severe disease in a global trial two weeks post-vaccination, with the company seeking authorization for use in individuals ages 18 and older.
If the committee endorses the vaccine, and the FDA clears the J&J shot for U.S. use, it will not boost vaccine supplies significantly right away. Only a few million doses are expected to be ready for shipping in the first week. But J&J told Congress this week that it expects to provide 20 million doses by the end of March and 100 million by 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 awful virus. More production means more people will be vaccinated sooner – to mitigate transmission, quell 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 Centers for Disease Control and Prevention (CDC) chief medical officer, recently told Fox News in an interview.
"The availability of additional vaccines should help address the gap between the number of people who qualify for and want vaccination and vaccine availability. This is great news," added Dr. Alan Kadish, physician and president of the Touro College & University System, to Fox News.
Studies have shown that the Pfizer and Moderna vaccines are 95% effective at protecting against symptomatic COVID-19, a greater efficacy when compared to the J&J jab at 66.9%. Should Americans be worried about which vaccine they get, especially if the J&J one has reduced effectiveness?
Not really, said Amler.
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"Let’s look at practical efficacy, rather than efficacy reported from studies of closely monitored populations" he suggested. "Practical efficacy is affected by many additional real-world factors not found in studies."
For instance, said Amler, J&J’s single-dose gives it an advantage over its two-dose counterparts simply because it’s a one-dose jab.
"Think of all the 2nd-dose appointments avoided, that people won’t forget or miss. Think of the much easier refrigeration requirement versus extreme low-temperature freezing when shipping and storing vaccine. With these practical factors, we can consider the vaccines are practically equivalent," he continued.
It’s worth noting, however, that the FDA said Thursday it is allowing more flexible shipping and storage temperatures for the Pfizer-BioNTech coronavirus vaccine. The change permits transportation and two-week storage at -25 degrees Celsius to -15 degrees Celsius, which is often found in pharmaceutical freezers and refrigerators.
When it comes to choosing a vaccine, if the country ever reaches a point where that is an option, the two experts had mixed responses, with Amler noting 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."
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"I think that for the next several months, people should get whatever vaccine is available to them because they are all substantially effective. It could be that by late summer or fall, individuals will have a choice and at that point, we will have additional data to determine if one vaccine is better than the other," added Kadish.
Finally, is there anyone who should avoid the J&J jab, considering it is an experimental viral vector vaccine that uses a weakened live pathogen — adenovirus in this case?
While Amler advised waiting for official recommendations following official emergency use authorization, Kadish noted that some groups may need to avoid the J&J vaccine due to the way it was created.
"Patients who are immune-suppressed or perhaps those who are pregnant should not get the live-action [vaccine]," said Kadish. 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 get vaccinated as soon as possible.
"Everyone should get vaccinated as soon as vaccine is available and they are eligible. If young people who are eligible due to underlying conditions feel awkward lining up with seniors, they should look past their embarrassment and get the protection," Amler advised.
Fox News' Kayla Rivas and the Associated Press contributed to this report.