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Dr K Aggarwal President CMAAO, HCFI, With input from Dr Monica Vasudev
FDA Grants Emergency Use to Johnson & Johnson COVID-19 Vaccine
India
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New Delhi, February 28, 2021 :
- The US Food and Drug Administration (FDA) granted emergency use authorization (EUA) to the Ad26.COV2.S vaccine from Janssen/Johnson & Johnson (J&J) for people 18 and older after reviewing its safety and efficacy data.
- J&J vaccine offers one-dose convenience and storage at conventional refrigeration temperatures.
- We have yet a third vaccine that is highly effective at preventing COVID, and even more effective at preventing severe COVID
- This vaccine has also been shown to be effective against the B.1.351 strain that was first described in South Africa
- One recent concern centers on people aged 60 years and older. Documents the FDA released earlier this week suggest a lower efficacy, 42%, for the J&J immunization among people in this age group with certain relevant comorbidities. In contrast, without underlying conditions like heart disease or diabetes, efficacy in this cohort was 72%.
- s possible, said Raj Shah, MD, geriatrician, and associate professor of family medicine and codirector of the Center for Community Health Equity at Rush University in Chicago, Illinois.
- Experience with the J&J vaccine so far suggests reactions are less severe.
- Low-grade fever, chills, or fatigue after vaccination can be considered a positive because they can reflect how well the immune system is responding
- Single-dose administration could be more than a convenience — it could also help clinicians vaccinate members of underserved communities and rural locations, where returning for a second dose could be more difficult for some people.
- When we have more than one dose that has to be administered, that some people will drop off and not come back for the second vaccine. This group could include the needle-phobic, he added. “For them, having it done once alleviates a lot of the anxiety.
- The phase 3 ENSEMBLE study of the J&J vaccine revealed a 72% efficacy for preventing moderate-to-severe COVID-19 among US participants. In contrast, researchers reported 94% to 95% efficacy for the Pfizer/BioNTech and Moderna vaccines. No participants who received the J&J vaccine in the phase 3 trial died from COVID-19-related illness. There were five such deaths in the placebo cohort.
- One of the things that these vaccines do very well is they minimize severe disease
Immunization of people 70 and older with the Pfizer/BioNTech COVID-19 vaccine in Israel was associated with a precipitous drop in need for mechanical ventilation. Compared with residents younger than 50 — so far vaccinated at lower rates than the higher-risk older people — Israelis 70 and older were 67% less likely to require mechanical ventilation for SARS-CoV-2 infection in February 2021 compared with October-December 2020. The study was reported online February 26, 2021, in Morbidity and Mortality Weekly Report (MMWR).
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