Health authorities such as FDA are commissioned to address consumer health concerns and ensure safe and effective products are placed on the market. On April 13, 2021, the FDA announced its actions in response to the coronavirus pandemic. There are now 358 tests and sample collection devices that have been granted approval by the FDA for Emergency Use Authorization (EUA). What has gained great attention are the 3 vaccines approved by EUA – Pfizer-BioNTech COVID-19, Moderna Covid-19, and Janssen COVID-19 vaccines. Side effects were noted with each of these vaccines in clinical trials and as a condition of approval, each manufacturer is required to follow periodic reporting requirements of adverse effects from the vaccine to FDA. However, consumer interest in the recent pause to the Janssen COVID-19 vaccination has created more communication about the safety and efficacy of this vaccine (6 reported cases of rare and severe blood clots in vaccinated people). The objective has been to ensure the benefits continue to outweigh the risks of using the COVID-19 vaccines (1).
As with any regulated drug, device, food product, FDA will require reporting of foreseeable and unforeseeable adverse side effects to the vaccines.
The side effects for Johnson & Johnson’s Janssen COVID-19 Vaccine were observed during the clinical trial 1-2 days after the single vaccination dose was administered and lasted 1-2 days with mild to moderate severity. Those side effects included pain at the injection site, headache, fatigue, muscle aches and nausea (2). Furthermore, the common side effects of the Pfizer-BioNTech COVID-19 Vaccine were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, vomiting, and fever which lasted for 2-14 days (3). Common side effects experienced with the Moderna COVID-19 Vaccine were similar to those mentioned for the Pfizer -BioNTech COVID-19 Vaccine (4).
The EUA approval process allows FDA and manufacturers to offer a feasible solution to the coronavirus pandemic along with other precautionary recommendations such as social distancing, frequent hand washing, and properly wearing a face mask. The EUA is a necessary process to address immediate health concerns. It is expected that Pfizer, Moderna, and Janssen would continue to collect postmarket data under the EUA to eventually support a Biologics License Application or BLA.
You and your healthcare provider should determine the best vaccination approach to use.
References:
- Emergency Use Authorization for Vaccines to Prevent COVID-19: Guidance for Industry, February 22, 2021. https://www.fda.gov/media/142749/download
- Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers): Emergency Use Authorization (EUA) Of the Janssen Covid-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19), March 19, 2021. https://www.fda.gov/media/146304/download
- Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers): Emergency Use Authorization (EUA) of the Pfizer-Biontech COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-2019, April 6, 2021. https://www.fda.gov/media/144413/download
- Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers): Emergency Use Authorization (EUA) of the Moderna COVID‑19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19), March 31, 2021. https://www.fda.gov/media/144637/download