Breaking News: NAFDAC Approves New COVID-19 Vaccine

704 views | Stanley Ugagbe | May 18, 2021

The National Agency for Food and Drug Administration and Control (NAFDAC), has granted approval for the conditional emergency use of Janssen COVID-19 vaccine in Nigeria.

According to Sahara Reports, the director-general of NAFDAC, Prof. Mojiola Adeyeye, in a statement on Tuesday, said information on the vaccine shows it met the criteria for efficacy, safety and quality.

Adeyeye said, “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.

In her words, the trial showed a 67 per cent reduction in the number of symptomatic COVID-19 cases after two weeks in people who received Janssen COVID-19 Vaccine.

It was stated that 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.

Remarking on the vaccine safety, Adeyeye said NAFDAC, in line with its pharmacovigilance and safety monitoring plan for COVID-19 vaccines, will closely monitor and subject the Janssen COVID-19 Vaccine to several activities that apply specifically to COVID-19 vaccines.

It is important to note that Janssen COVID-19 vaccine is the third vaccine recommended for administration in the country.

 

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