NAFDAC Authorises Use of Moderna, AstraZeneca Vaccines, Conditionally Recommends Sputnik V

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NAFDAC Authorises use of  Moderna, AstraZeneca Vaccines, conditionally recommends Sputnik V
Prof. Moji Adeyeye

In its quest to provide variety of safe vaccines for the Nigerian population, the management of the National Agency for Food and Drug Administration and Control (NAFDAC) has approved Moderna and AstraZeneca vaccines and while it conditionally approved Sputnik V vaccine.

The agency made the announcing on Thursday in a statement signed by the Director General, Prof, Moji Adeyeye, noting that the NAFDAC Vaccine Committee has been carefully assessing several vaccines despite the fact the vaccines have been approved by stringent regulatory countries or have received WHO’s Emergency Use Listing (EUL).

This comes as the Executive Director of the NPHCDA, Dr. Faisal Shuaib disclosed on Tuesday at a press conference that Nigeria has exhausted the first batch of the AstraZeneca vaccines shipped to the country by the COVAX facility. He added that about 4 million eligible Nigerians have been vaccinated across the country during the first phase of vaccination, as the agency prepares for the second vaccination phase.

He said: “Nigeria has successfully vaccinated 3,938,945 eligible persons across 36 States and FCT, representing 98% utilization of the 4,024,000 doses of Oxford/AstraZeneca vaccine it received from COVAX facility in March 2021.

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“This comprises 2,534,205 people who have been vaccinated for first dose, and 1,404,205 who have received their second dose of the vaccine”.

He however debunked the rumour making the rounds that there are expired AstraZeneca vaccines in circulation, saying, “There is no vaccine that expired in Nigeria, because we still have a lot of headroom before expiry date of July 29. If vaccines were withdrawn from some states, it was because they were deployed to other states and local government that needed more vaccines. No vaccines expired in Nigeria”, he reiterated.

According to the NAFDAC DG, the agency spends at least 15 days to thoroughly examine the dossier or submission package of the vaccine to ensure that the benefits of the vaccine far outweigh the risks and any side effects are well noted for monitoring after vaccination by respective NAFDAC and primary health officers. The EUL will allow Nigeria to receive supplies of the vaccines from the COVAX facility.

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“Moderna and AstraZeneca AZD1222 vaccines have received WHO EUL listing and were given expedited approvals. Sputnik V is yet to receive the EUL approval and therefore was subjected to full six-month review by NAFDAC. The Agency was granted access to the dossiers and prior assessment reports of Moderna and AstraZeneca from the WHO website at different times over the past two months.

“Moderna vaccine is presented as a white to off-white, ready-to-use dispersion for intramuscular injection in a multi-dose vial containing 6.3ml (10 doses) in a 10-vial pack. Each dose (0.5ml) contains 100 micrograms of messenger RNA (mRNA) (embedded in SM-102 lipid nanoparticles that serve as the delivery matrix).  It is a two-dose vaccine.

“AstraZeneca AZD1222 COVID-19 vaccine is a recombinant ChAdOx1 adenoviral vector encoding the structural surface glycoprotein (Spike protein) antigen of the SARS-CoV-2 from SK Bioscience Co Limited (Republic of Korea).  It is  colourless to slightly brown, clear to  slightly opaque packed as a 5ml solution that contains 5 x 1010 virus particles for injection in a 5ml  clear glass multidose vial that could be stored at 2-8OC. It is given as a two-dose injection of 0.5ml/dose.

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“Sputnik V Vaccine is supplied as a two-component product, both of which are 3ml (5 doses) solution for intramuscular injection in glass vial. It is a two-dose injection. Each 0.5ml dose of the Component I is formulated to contain virus particles (1.0±0.5) x 1011 of Ad26 vector encoding the S glycoprotein of SARS-CoV-2.  The product has a shelf life of six (6) months when stored at -18C or three (3) months when stored at 2-8C”, she explained.

Adeyeye said the agency through the Pharmacovigilance unit will conduct safety and monitoring studies on the vaccines to record the side effects and adverse effects following immuniaation.She further stated that other studies like immunological responses, incidences of reactogenicity and possible dose optimisation will be done in a cohort of vaccines,

 

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