Johnson & Johnson Asks FDA To Approve Booster Shot

NEW BRUNSWICK, NJ — On Tuesday, Johnson & Johnson asked the Food and Drug Administration to allow booster shots of its COVID-19 vaccine for those ages 18 and older. The company argues that its booster shot provides a "rapid and robust increase" in COVID-19 antibodies 28 days after an individual receives the first "single-shot" dose.

Earlier in September, Johnson & Johnson already said that a second booster shot makes their coronavirus vaccine up to 94 percent effective at preventing severe disease. The drug maker has also said that antibody responses can hold up for eight months after inoculation.

“We look forward to our discussions with the FDA and other health authorities to support their decisions regarding boosters,” said Dr. Mathai Mammen, the global head of research and development at J&J’s vaccine development arm, in a statement.

“At the same time, we continue to recognize that a single-shot COVID-19 vaccine that provides strong and long-lasting protection remains a crucial component to vaccinating the global population.”

Johnson & Johnson is headquartered in New Brunswick and the company actually used Rutgers students in their coronavirus vaccine trials last November.

To date, Pfizer is the only coronavirus vaccine approved by the FDA to be given as a booster. The FDA has not approved the Moderna or Johnson & Johnson vaccine for boosters.

Related: COVID-19 Booster Shot Or Third Dose? Here's The Difference

As of Oct. 6, Pfizer booster shot eligibility extends to anyone who received the two-shot vaccine six months ago and more and who are:

• 65 years or older and who live in long-term care facilities;
• Between the ages of 50 and 64 and have underlying medical conditions;
• Between the ages of 18 and 49 and have underlying medical conditions based on their benefits and risks; and
• Between the ages of 18 and 64 and are at increased risk of exposure to the coronavirus due to their employment, including healthcare workers, teachers, grocery store workers and public transportation employees, among others.

So far in New Jersey, 132,000 Pfizer additional shots have been given out and 49,000 Moderna shots, although the Moderna shots are technically not considered "boosters," Gov. Phil Murphy said Monday.

"The Moderna shots are not boosters, per se. They’re third shots, so those have been eligible since I think mid-August, and that is for folks with chronic medical conditions — immunocompromised, pardon me, is the phrase," said Murphy.

Moderna has already applied for emergency-use authorization for its COVID-19 vaccine booster shot, but the FDA has not yet responded to its September inquiry. An FDA panel is slated to meet Oct. 14 to discuss the Moderna booster.

"The Moderna third dose is ... for those that are moderately or severely immunocompromised, active cancer treatment, solid organ transplant individuals," said Department of Health Commissioner Judith Persichilli at the Monday press conference. "The Pfizer, actually, is both their third dose and booster, and that’s 127,188."

However, on Sept. 7 a Seattle-area woman died from blood-clot complications after getting a single dose of Johnson & Johnson's vaccine. She is believed to be the fourth such death from the J&J shot, according to The Hill.

The woman, Jessica Berg Wilson, was in her late 30s, received her J&J vaccination on August 26 and died on September 7, said King County in a statement.

"Her cause of death was determined to be thrombosis with thrombocytopenia syndrome (TTS), a condition that has been identified as a rare but potentially serious adverse event in people who received the J&J vaccine," said King County. "The diagnosis was confirmed by the CDC."

The CDC has reported three other confirmed similar deaths nationally after getting the Johnson & Johnson shot; this woman is the fourth.

The TTS syndrome is rare: So far about 15 million J&J shots have been administered and 38 people have had confirmed cases of TTS, according to the CDC. The majority of those cases have recovered.
In April, the CDC paused use of the Johnson & Johnson vaccine to study the blood clot side effect, but resumed use saying that the risk of the blood clot syndrome outweighed the benefits.

Before Johnson & Johnson started researching a booster shot, their one-shot vaccine provided about a 75 percent overall efficacy against severe/critical COVID-19, according to the company. It gave an 89 percent efficacy against hospitalization and 83 percent protection against COVID-19-related death.

In New Jersey, the Johnson & Johnson jab made up less than four percent of the state's total vaccine supply, with the state much more heavily relying on Pfizer and Moderna, said Gov. Murphy.

Persichilli has noted that, given COVID-related upticks in cases and deaths, the state health department strongly encourages all eligible residents to get vaccinated as soon as possible, including the third dose of Pfizer or Moderna for those who are immunocompromised.

You can find a local vaccination site in New Jersey at covid19.nj.gov/finder or by calling 1-855-568-0545. Caregivers or representatives of immunocompromised, homebound individuals can contact the New Jersey Vaccine Call Center at 855-568-0545 for additional guidance.

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