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NAFDAC approves use of Johnson & Johnson COVID-19 Vaccine

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The National Agency for Food and Drug Administration and Control (NAFDAC) has approved the emergency use of Janssen (Johnson & Johnson) COVID-19 Vaccine for Nigerians above 18.the Director General of the agency, Professor Mojisola Adeyeye, disclosed this in a statement released in Abuja on May 18.

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“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.

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The data also show that the vaccine’s known and potential benefits outweigh it’s 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.

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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.

 

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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 percent reduction in the number of symptomatic COVID-19 cases after 2 weeks in people who received Janssen COVID-19 Vaccine.

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The most commonly reported side effects is were pain at the injections site, headache, fatigue, muscle aches, and nausea. Most of these side effects were mild to moderate in severity and lasted 1-2 days”.

 

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On safety of the vaccine, Mojisola Adeyeye, assured that the vaccine will be closely monitored and subjected to several activities. She also added that Manufacturers would be required to provide a monthly safety reports as well as a regular update generated by NAFDAC activities

She said:

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

Manufacturer’s 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 ti defend itself against COVID-19.

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Unopened vacine vials can be stored and/or transported frozen at 25 degree to 15 degree for up to 24 months and 3 months when stored at 2 to 8 degree.

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

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