- Johnson & Johnson on Tuesday asked the FDA to authorize a booster shot of its COVID-19 vaccine this week
- A meeting was scheduled for October 15 to discuss the booster for J&K, before it was filed for approval by the company.
- Last month, J&J published data showing the second shot of its COVID-19 vaccine rose to 94% two months after the first.
- By comparison, the standard single dose regimen is 70% effective against symptomatic disease.
- J&J also noted that boosters given two months after the first dose increased antibody levels between four-fold and six-fold.
Johnson & Johnson on Tuesday asked the US Food and Drug Administration (FDA) to authorize a booster shot of its COVID-19 vaccine.
The New Brunswick, New Jersey-based company said it filed a request with the FDA to authorize boosters for Americans age 18 and older.
While J&J said it submitted data on several different booster intervals, ranging from two to six months, it did not formally recommend one to regulators.
Last month, the FDA authorized booster shots of Pfizer’s vaccine for older Americans and other groups with high vulnerability to COVID-19.
It is part of a broader effort by the Biden administration to increase protection among the Delta variant and potentially waning vaccine immunity.
Johnson & Johnson on Tuesday asked the FDA to authorize a booster shot of its COVID-19 vaccine this week. Pictured: A Johnson & Johnson COVID-19 vial at a Culver City Fire Department vaccination clinic in Culver City, California in August 2021
A meeting was scheduled for October 15 to discuss the J&K booster, before it was filed for approval by the company. Image: Chandler Millard (left) of Alexandria, Virginia, receives the National Park’s Johnson & Johnson Vaccine in September 2021
J&J previously released data suggested its vaccine remains highly effective against COVID-19 for at least five months after vaccination, demonstrating an 81 percent effectiveness against hospitalizations in the US.
But the company’s research shows that immunity increases even more with a booster dose in two or six months.
Phase III, a two-dose trial of 30,000 participants, looked at the effectiveness of a second dose 56 days after the first dose in adults 18 years of age and older.
Results published last month showed that the booster shot was 94 percent effective against symptomatic COVID-19 in the US and 100 percent effective against severe disease at least 14 days after vaccination.
This compares to the 70 percent protection seen with a single dose.
There was only one case of COVID-19 in the vaccine group and 14 in the placebo group.
J&J said boosters given two months after the first dose increased antibody levels between four-fold and six-fold.
When given six months after the first dose, antibody levels increased nine-fold after one week and 12-fold after four weeks.
J&J’s vaccine was considered an important tool in fighting the pandemic because it only required one shot, but the company has faced setbacks, with 229 million receiving J&J compared to the 15 million Americans who received it. has received Pfizer and 152 million who have received Moderna
These increases were observed regardless of age.
Side effects of the two doses were comparable to those seen in studies with the single-dose vaccine.
FDA advisors will review studies by the company and other researchers next Friday and vote on whether to recommend the booster.
The timing of the J&J filing was unusual because the FDA had already scheduled its meeting on the company’s data.
Companies typically submit their requests prior to completing announcements. A J&J executive said the company is working with the FDA on the review.
Dr Mathai Maimon, head of research at J&J’s Janssen unit, said: “There is a sense of urgency in both J&J and the FDA because this is COVID and we want the good data out there to be converted into action as quickly as possible.
Government advisers backed the additional Pfizer shots authorized last month, but they were also concerned about causing confusion for the millions of other Americans who received Moderna and J&J shots.
US officials do not recommend mixing and mixing different vaccine brands.
It is the first step in the review process that also includes sign-offs from both the FDA and the Centers for Disease Control and Prevention.
If both agencies go ahead, Americans may start getting J&J and Modern boosters later this month.
The J&K vaccine was considered an important tool in fighting the pandemic as it requires only one shot.
But its rollout was hurt by several troubles, including manufacturing problems at the Baltimore factory, which forced J&K to import millions of supplements from overseas.
Additionally, regulators have added warnings of several rare side effects to the shot, including a blood clotting disorder and a neurological reaction called Guillain-Barré syndrome.
In both cases, regulators decided that the benefits of the shot still outweighed those unusual risks.
Rival drugmakers Pfizer and Moderna have provided the vast majority of US COVID-19 vaccines.
More than 170 million Americans have been fully vaccinated with the companies’ two-dose shots, while less than 15 million Americans have received the J&J shot.