March 2, 2021, 3:44 p.m. Michael Devitt — Roughly 10 weeks after the CDC approved the use of vaccine candidates from Pfizer/BioNTech and Moderna, the agency has given approval to a third vaccine candidate from Janssen Biotech, a subsidiary pharmaceutical company of Johnson & Johnson, giving family physicians yet another tool in the ongoing battle against the virus that causes COVID-19.
The vaccine received CDC approval on Feb. 28 following a 12-0 vote (with one recusal) by the CDC’s Advisory Committee on Immunization Practices to recommend the vaccine for use in individuals age 18 and older.
The CDC’s actions were preceded by a Feb. 26 recommendation by the FDA’s Vaccines and Related Biological Products Advisory Committee, which voted unanimously (22-0) in favor of granting an emergency use authorization for the Janssen/Johnson & Johnson vaccine. The FDA issued an emergency use authorization for the vaccine a day later.
The ACIP’s full interim recommendation for use of the Janssen/Johnson & Johnson vaccine was published as a Morbidity and Mortality Weekly Report Early Release on March 2.
The AAFP reviews all ACIP recommendations for approval through the Commission on Health of the Public and Science. As distribution and administration of the Johnson & Johnson vaccine is expected to begin as early as this week, members of the commission’s executive committee reviewed the clinical trial data and the balance of benefits and harms presented by the ACIP. The Board chair approved the executive committee’s recommendation for supporting ACIP’s 2021 interim recommendation for use of the vaccine under an EUA.
“Having an additional vaccine that can be given in a wider diversity of settings is a game changer,” said Julie Wood, M.D., M.P.H., the Academy’s senior vice president for research, science and health of the public. “Family physicians stand ready to assist state and local jurisdictions to vaccinate patients, including those in underserved or vulnerable areas.”
Based on the FDA’s authorization and the CDC’s recommendation, family physicians and other health care professionals may be able to start receiving the first distributions of the Janssen/Johnson & Johnson vaccine as early as this week. The Academy’s COVID-19 Vaccine Distribution webpage contains several resources to help FPs find vaccine distribution plans for their specific state and jurisdiction.
There are several differences between the Janssen/Johnson & Johnson vaccine and those produced by Pfizer and Moderna, some of which may provide important logistical advantages for vaccine delivery.
First, the Janssen/Johnson & Johnson vaccine is administered in a single dose, which eliminates the need for patients to return for a second dose and frees up future appointment times for other patients to receive the vaccine.
Second, the Janssen/Johnson & Johnson vaccine can be safely stored in a refrigerator and remain stable for several months at routine refrigeration temperatures between 2 degrees and 8 degrees Celsius (35.6 degrees to 46.4 degrees Fahrenheit). This means that most family physicians and other health care professionals can store vials of the vaccine in their own office or clinic, unlike the Pfizer and Moderna vaccines, which require storage at lower temperatures using more sophisticated refrigeration equipment.
Third, while the Pfizer/BioNTech and Moderna vaccines are based on technology that uses messenger RNA, the Janssen/Johnson & Johnson vaccine relies on more traditional technology — in this case, a modified adenovirus vector vaccine called adenovirus type 26. The vaccine uses Ad26 to deliver a piece of DNA that creates the signature spike protein of the SARS-CoV-2 virus, but Ad26 has been modified for the vaccine so it cannot replicate in the human body to cause illness. It does not alter the human genome or cause mutations.
All three authorized COVID-19 vaccines are effective against disease, hospitalization and death. For the Janssen/Johnson & Johnson clinical trial, data from an analysis of more than 39,000 participants found that overall, the vaccine was about 67% effective in preventing moderate to severe/critical COVID-19 occurring at least 14 days after vaccination and 66% effective in preventing moderate to severe/critical COVID-19 occurring at least 28 days after vaccination.
It should be noted that the Janssen/Johnson & Johnson vaccine’s effectiveness rates were higher among trial participants in the United States compared with participants in other countries such as South Africa. In the U.S. participant group, the vaccine was 74.4% effective and 72% effective in preventing moderate to severe/critical COVID-19 occurring at least 14 days and 28 days after vaccination, respectively.
Similar (and even lower) rates of adverse events were observed compared to the other authorized vaccines. Most commonly reported adverse events included injection site pain (48.6%), headache (38.9%), fatigue (38.2%), myalgia (33.2%), nausea (14.2%) and fever (9%). Withdrawal and death due to serious adverse events were rare and no differences were observed between groups. The AAFP has posted additional details and a comparison of safety and efficacy data across the three trials on its COVID-19 Vaccine Safety and Efficacy Data Overview webpage.
Although the Janssen/Johnson & Johnson vaccine was observed to have a lower efficacy, it is important to note that none of the vaccines have been compared head-to-head and the trials were carried out under different circumstances and time points in the pandemic. The CDC did not issue a preferential recommendation for any of the vaccines, and the agency is asking that physicians encourage patients to get whichever vaccine is available to them.
According to an FDA fact sheet for patients, the Janssen/Johnson & Johnson vaccine should not be administered to individuals with a known history of a severe allergic reaction to any component of the vaccine.
The CDC will be updating its interim clinical considerations to include Janssen/Johnson & Johnson vaccine information.
The agency has also published additional guidance for patients on what to do if they experience an allergic reaction to any COVID-19 vaccine, along with recommendations for those who administer vaccines on how to prepare for the possibility of severe allergic reaction. An early analysis of Vaccine Adverse Event Reporting System data published in MMWR on Jan. 6 indicated that anaphylaxis due to vaccination against COVID-19 is exceedingly rare.
The Academy, meanwhile, will continue to keep members aware of the latest news related to COVID-19. Members are invited to visit the AAFP’s COVID-19 webpage, which is updated regularly with the latest news and information, and the AAFP COVID-19 Vaccine webpage, which provides vaccine-related resources. At 7 p.m. CT March 2, the AAFP will host a webinar on COVID-19 vaccines that discusses clinical updates and considerations for practices and patients; CME credit is available for this activity. The event will be available to view after the live session.
The Academy is also providing resources through its patient-centered website, Familydoctor.org, to ensure that patients have the latest information on COVID-19 and that they learn about the safety and benefits of vaccines for COVID-19 and other infectious diseases.