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Safety Update For Covid-19 Vaccine Phase 1 Introduction In Nigeria: Vol 001

June 15, 2021,

The National Agency for Food and Drug Administration and Control (NAFDAC) working closely with the National Primary Health Care Development Agency (NPHCDA) and other relevant stakeholders has put in a place a robust mechanism to actively monitor the safety of the novel ChAdOx1 nCoV-19 Corona Virus Vaccine (Recombinant) Covishield vaccine in Nigeria through enhanced passive AEFI surveillance at vaccination centers around the country.`

NAFDAC implemented a targeted/enhanced passive surveillance approach where trained pharmacovigilance focal persons were deployed to the field to monitor the COVID-19 vaccine implementation. They followed up identified vaccinees who had received their first dose of the vaccine through phone calls to monitor for some solicited AEFIs for the first seven days after immunization using a designed questionnaire. The reported AEFIs were then uploaded in the Med Safety App. This evidenced the increase in the number of AEFIs reported in the Med Safety App as a new reporting tool. The objective was to allow for further characterization of the safety profile within our own population since the full safety profile of the vaccines is yet to be characterized globally.

As at 25th May, 2021, the National Primary Health Care Development Agency had vaccinated 1,929,237 with few and mild side effects being reported. The most common side effects being headache, fever, injection site tenderness, pain in the arm, chills, itching, local reactions, malaise, Myalgia, dizziness,  rash, general body pains which generally resolved within 48 hours post-vaccination.

The National Expert Committee on AEFI Causality Assessment established to review all cases of AEFIs/AESIs held its first meeting on the 4th to 8th May, 2021 to review all cases of AEFIs presented to them. The Committee assessed all reports and based on available evidences and resources from both local and international journals, the Committee continues to favour the futher use of Covishield Astrazeneca vaccine as the benefit of the vaccine far outweigh the risks posed by the vaccine.

The Nigeria data clearly shows that the Covishield vaccine is safe and well tolerated within the population and the benefits far outweighs any associated risks. NAFDAC encourages all vaccinees who received the first dose to go for the second dose as the data obtained from countries that have commenced the administration of the second round of doses shows that the AEFIs were even fewer, more mild and well tolerated by vaccinees.

NAFDAC will intensify its surveillance and continue to actively monitor the safety profile of all Covid-19 vaccines deployed to fight the pandemic by collating AEFI data, processing and analyzing them and making the findings available to the Nigerian citizenry. Data generated from surveillance and active monitoring will be used for informed regulatory decisions on the continued use of the COVID-19 vaccines in Nigeria.

Prof Mojisola Christianah Adeyeye

Director General

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