Johnson & Johnson releases side effects for COVID-19 booster shot

Coronavirus

FILE – In this Wednesday, March 3, 2021 file photo, a pharmacist holds a vial of the Johnson & Johnson COVID-19 vaccine at a hospital in Bay Shore, N.Y. Janssen Pharmaceuticals is a division of Johnson & Johnson. On Wednesday, Oct. 13, 2021, the Food and Drug Administration said it is wrestling with whether and when recipients of the single-shot Johnson & Johnson COVID-19 vaccine need another dose — at six months or as early as two months. (AP Photo/Mark Lennihan)

RALEIGH, N.C. (WNCN)- The FDA was scheduled to debate the need for COVID-19 boosters for the Moderna and Johnson & Johnson vaccine this week.

Johnson & Johnson said at the start of the pandemic that one shot of its vaccine was sufficient to provide protection.

In documents submitted to the FDA, the company said given the state of the pandemic and variants, “focus may shift to protecting individuals by maximizing and prolonging vaccine-induced protection, not only against severe/critical COVID-19, but also against symptomatic infection, to potentially reduce transmission, and raise immunity to increase the probability of protection against future variants of concern.”

Johnson & Johnson has given the FDA two options for boosters: a second shot at the two-month and six-month mark.

It is recommending a booster at the six-month mark.

For people who got boosters at the two-month mark, systemic side effects like fatigue and headache were reported more often for the first dose than the second.

Post-dose one, 58.5 percent reported side effects while 52.7 percent of people reported after dose two.

Injection site side effects were reported for 55.6 percent of people after dose one and 57.5 percent of people reported after dose two. Below are side effects for people who were boosted at the two-month mark.

SYMPTOMDOSE 1DOSE 2
Fatigue44.9%41.1%
Headache42.8%35.8%
Muscle Pain38.9%34.7%
Nausea18.1%14.4%
Fever5.0%2.4%
Injection site pain 54.2%56.3%
Injection site swelling5.5%5.6%
Injection site redness8.7%8.2%

In the six-month booster group, side effects were less frequent after the booster.

Local site reactions were reported for 82.8 percent of people post-dose one and 78.9 percent of participants post-booster.

Systemic side effects were reported for 79.3 percent and 57.9 percent of participants in the booster group post-dose one and post-booster, respectively. Below are side effects for people who were boosted at the six-month mark.

SYMPTOMDOSE 1DOSE 2
Fatigue58.6%26.3%
Headache55.2%47.4%
Muscle Pain58.6%21.1%
Nausea27.6%10.5%
Fever10.3%
Injection site pain 54.2%50.0%
Injection site swelling5.5%3.3%
Injection site redness8.7%2.8%

Johnson & Johnson said it observed lower levels of side effects in older populations compared to younger populations. It said no new safety concerns were seen after the booster

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