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Recommendation For Emergency Use Authorization Of Janssen (Johnson & Johnson) Covid-19 Vaccine

May 17, 2021,

The National Agency for Food and Drug Administration and Control (NAFDAC) is hereby granting conditional Emergency Use Authorization for Janssen COVID-19 Vaccine to prevent COVID-19 in people from eighteen (18) years of age.

After a thorough evaluation, the NAFDAC Vaccine Committee concluded that the data on the vaccine were robust and met criteria for efficacy, safety and quality.  The data also show that the vaccine’s known and potential benefits outweigh its known and potential risks thereby supporting the manufacturer’s recommended use. Janssen COVID-19 Vaccine is the third vaccine recommended in Nigeria for preventing COVID-19.

VACCINE EFFICACY

The Janssen COVID-19 Vaccine is administered as a single dose. Results from a clinical trial involving people in the United States, South Africa and Latin American countries found that Janssen COVID-19 Vaccine was effective at preventing COVID-19 in people from 18 years of age.

The Phase III clinical trial involved over 44,000 people. Half received a single dose of the vaccine and half were given placebo (a dummy injection). People did not know if they had been given Janssen COVID-19 Vaccine or placebo.

The trial found a 67% reduction in the number of symptomatic COVID-19 cases after 2 weeks in people who received Janssen COVID-19 Vaccine. The most commonly reported side effects were pain at the injection site, headache, fatigue, muscle aches and nausea. Most of these side effects were mild to moderate in severity and lasted 1-2 days.

VACCINE SAFETY

In line with the NAFDAC’s Pharmacovigilance and safety monitoring plan for COVID-19 vaccines, Janssen COVID-19 Vaccine will be closely monitored and subject to several activities that apply specifically to COVID-19 vaccines.

Manufacturers are required to provide monthly safety reports in addition to the regular updates generated by NAFDAC activities.

Janssen COVID-19 Vaccine works by preparing the body to defend itself against COVID-19.

Unopened vaccine vials can be stored and/or transported frozen at -25°C to – 15°C for up to 24 months and 3 months when stored at 2 to 8°C.

The Ministry of Health and National Primary Health Care Development Agency will announce when the vaccine becomes available for use in Nigeria.

NAFDAC………safeguarding the health of the Nation!!!

Director General

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