CDC Advisors Recommend Johnson & Johnson COVID-19 Vaccine

March 09, 2021 - Johnson & Johnson recently announced that the CDC’s Advisory Committee on Immunization Practices (ACIP) recommended its single-shot COVID-19 vaccine under the recent FDA emergency use authorization.

ACIP is made up of independent health experts that advise the CDC on the types of populations and circumstances for which vaccines should be used. For Johnson & Johnson’s vaccine, ACIP recommended the vaccine for individuals 18 years of age and older.

The ACIP recommendation for Johnson & Johnson’s single-dose vaccine will be forwarded to the Director of the CDC and HHS for review and adoption.

“For more than 130 years, Johnson & Johnson has come to the aid of people during times of crisis, and we believe today’s recommendation from the CDC to begin use of our vaccine as part of the U.S. national immunization program will add a critical tool in the fight against COVID-19,” Paul Stoffels, MD, vice chairman of the executive committee and chief scientific officer at Johnson & Johnson, said in the announcement.  

“This recommendation follows the FDA’s decision to grant an Emergency Use Authorization for our single-shot vaccine, which has the potential to play a pivotal role in helping to end the COVID-19 pandemic,” Stoffels continued. 

Last week, FDA issued an emergency use authorization for the third COVID-19 vaccine to Johnson & Johnson. 

The emergency use authorization was based on an ongoing, multi-national Phase 3 trial that enrolled 43,783 participants. In the trial, 468 individuals had symptomatic cases of COVID-19. 

Researchers found that a single-dose of the vaccine, called Ad26.COV2.S was 67 percent effective in preventing moderate-to-severe and critical COVID-19 14 days after vaccination and 66 percent effective 28 days after vaccination.

Additionally, Ad26.COV2.S significantly helped infected individuals requiring medical intervention by reducing instances of hospitalization, ICU admission, mechanical ventilation, and extracorporeal membrane oxygenation. 

There were seven COVID-19 related deaths reported in the study, all of which were in the placebo group. There have been no coronavirus-related deaths in the Ad26.COV.2 group, the analysis said.

A separate FDA analysis following the authorization found that the vaccine met requirements for emergency use authorization. 

The agency found that Ad26.COV.2’s efficiency against laboratory-confirmed, moderate-to-severe COVID-19 was 66.9 percent 14 days after vaccination and 66.1 percent 28 days after vaccination. 

Secondary analysis showed that vaccine efficiency against severe or critical COVID-19 14 days after vaccination was 76.7 percent and 85.4 percent 28 days after vaccination. 

And a post hoc analysis of all COVID-19-related hospitalization starting 14 days after vaccination also found that there were just two cases of hospitalization in the vaccine group and no cases after 28 days versus 29 cases of hospitalization in the placebo group and16 cases after 28 days.

Johnson & Johnson has already begun shipping its COVID-19 vaccine and expects to deliver enough single-shot vaccines by the end of March to fully vaccinate over 20 million people in the US.

In total, the company plans to deliver 100 million single-shot vaccines to the US during the first half of 2021. The government will manage allocation and distribution of the vaccine in the US.

The vaccine will be shipped using the same cold chain technologies Johnson & Johnson currently uses to transport treatments for cancer, immunological disorders, and other medicines, the company stated. 

Ad26.COV.2 is estimated to remain stable for two years at -4 degrees Fahrenheit, or-20 degrees Celsius, and a maximum of three months at routine refrigeration at temperatures of 36-46 degrees Fahrenheit, or 2 to 8 degrees Celsius. 

Johnson & Johnson will file for a Biologics License Application (BLA) with FDA later this year and also recently submitted European Conditional Marketing Authorization Application to the European Medicines Agency.