CMAAO Coronavirus Facts and Myth Buster: FDA Grants Emergency Use Authorization to Johnson & Johnson COVID-19 Vaccine |
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CMAAO Coronavirus Facts and Myth Buster: FDA Grants Emergency Use Authorization to Johnson & Johnson COVID-19 Vaccine
Dr KK Aggarwal,  02 March 2021
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Withinput from Dr Monica Vasudev

1411:FDA Grants Emergency Use Authorization to Johnson & Johnson COVID-19Vaccine

1.    TheUS Food and Drug Administration (FDA) has given emergency use authorization(EUA) to the vaccine from Janssen/Johnson & Johnson (J&J) - Ad26.COV2.S- for individuals aged 18 years and older, following review of its safety andefficacy data.

2.     Thisis a single dose vaccine and can be stored at conventional refrigerationtemperatures.

3.     Thisis the third vaccine in the US that is highly effective for prevention of COVID-19,and is even more effective for the prevention of severe COVID-19.

4.     Thisvaccine has also been found to be effective against the B.1.351 strain that wasfirst identified in South Africa.

5.     Arecent concern is about individuals aged 60 years and older. The FDA had releaseddocuments earlier stating a lower efficacy of 42% for the vaccine among peoplein this age group with some relevant comorbidities. In the absence ofunderlying conditions like heart disease or diabetes, the vaccine efficacy inthis group was found to be 72%.

6.    Experiencewith this vaccine thus far suggests that the reactions are less severe.

7.     Low-gradefever, chills, or fatigue following inoculation can be considered as positive asthey can suggest that the immune system is responding well.

8.     Single-doseadministration is a convenience and could also help clinicians providevaccinations to the members of underserved communities and rural locations,where coming back for a second dose could be difficult for some of theindividuals.

9.  When more than one dose has to be administered, some people tend to drop offand not come back for the second dose. This may include people who areneedle-phobic. For such people, having a single dose vaccine relieves a lot ofthe anxiety.

10.  Thephase 3 ENSEMBLE study of the J&J vaccine demonstrated a 72% efficacy forpreventing moderate-to-severe COVID-19 among US participants. None of theparticipants who received the J&J vaccine in the phase 3 trial died fromCOVID-19-related illness. Five such deaths were reported in the placebo group.

 [Source: Medscape] 

Dr KK Aggarwal

President CMAAO, HCFI and Past NationalPresident IMA

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