On Oct. 13, U.S. drug regulators said a second shot of Johnson & Johnson’s single-shot COVID-19 vaccine could bolster people’s protection against the disease, but regulators did not have enough time to analyze the data the company submitted independently, The Epoch Times reported.
It appears the agency is reluctant to approve the request and has expressed some reservations over whether it will be effective or not and whether the data provided by J&J is actually correct.
The FDA pronounced its concerns especially over the “strength of evidence Johnson & Johnson provided in its application for booster shots,” it said in a memo. Furthermore, the agency suggested the tests used by Johnson & Johnson were “likely not sensitive enough.”
“It is likely that the results seen are due to the low sensitivity of the psVNA assay used,” the FDA stated in the report, hinting at the testing method Johnson & Johnson used during the trial phase of the booster vaccine.
However, the bureau still voiced its confidence that a second shot should bolster the immune system enough to provide immunity for symptomatic infection and severe disease across populations.
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The Johnsson & Johnson vaccine, which goes by the name ‘Janssen’, is based on adenovirus technology and was launched requiring only one shot, unlike the other vaccine-producing companies that use Messenger RNA technology and whose inoculations typically require two shots administered over four or more weeks.
As for J&J itself expressed no doubt that the booster shot would be the ultimate solution to bolster recipients against severe COVID-19 outcomes and all the disease’s variants.
“Based on the recent data, it can be assumed that the administration of the booster dose will result in increased protection against symptomatic infection, increased strength and breadth of immune responses against current variants, and increase of the magnitude of protection against severe disease across populations,” the company affirmed in its statement.
During a trial to test the booster’s safety and efficacy, 7,484 participants received a second shot while another 7,008 people received a placebo. The booster reinforced protection against both symptomatic COVID-19 and severe cases of the disease, the company said.
“The booster dose can also increase the probability of protection against future variants of concern,” it continued. “A booster dose is recommended at six months or later, based on the strength of the immune responses, although a booster dose may be administered as early as two months.”
Furthermore, the notice read that “the need for a booster dose and/or its timing will depend on the local/epidemiological situation and the needs of individuals/specific populations.”
Even with its limited time and resources deployed, the FDA still hinted at an upcoming authorization of the Janssen booster shot. “Although not independently confirmed by FDA from datasets, summaries of the data suggest there may be a benefit in a second dose administered approximately two months after the primary dose,” the bureau said.
The FDA plans to assess Moderna’s bid to provide booster shots on Thursday as well as the Johnson & Johnson vaccine on Friday following the approval for Pfizer booster shots on Sept. 22.
