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.
| SYMPTOM | DOSE 1 | DOSE 2 |
| Fatigue | 44.9% | 41.1% |
| Headache | 42.8% | 35.8% |
| Muscle Pain | 38.9% | 34.7% |
| Nausea | 18.1% | 14.4% |
| Fever | 5.0% | 2.4% |
| Injection site pain | 54.2% | 56.3% |
| Injection site swelling | 5.5% | 5.6% |
| Injection site redness | 8.7% | 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.
| SYMPTOM | DOSE 1 | DOSE 2 |
| Fatigue | 58.6% | 26.3% |
| Headache | 55.2% | 47.4% |
| Muscle Pain | 58.6% | 21.1% |
| Nausea | 27.6% | 10.5% |
| Fever | 10.3% | – |
| Injection site pain | 54.2% | 50.0% |
| Injection site swelling | 5.5% | 3.3% |
| Injection site redness | 8.7% | 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