Nigeria’s NAFDAC to licence global firm producing Covid vaccines in Q1 2021
National Agency for Food and Drug Administration and Control (NAFDAC) said it is considering licensing one of the vaccines under development globally for Covid-19 by end of first quarter of 2021 or early part of the second quarter.
“We are looking at the end of the first quarter of next year or the beginning of the second quarter” to approve a shot for use in Nigeria, NAFDAC Director-General Mojisola Adeyeye said.
Africa’s most populous country also expects to benefit from the World Health Organization (WHO) backed Covax initiative, which is working to improve access to vaccines for 92 low- and medium-income countries, Adeyeye said.
The Covax partnership is also operating on a similar timeline for licensing its first coronavirus vaccine, she said.
While Nigeria has recorded only 72,140 cases of Covid-19 and fewer than 1,190 deaths from the illness, cases of the disease have been climbing again this month, with 796 cases registered on Dec. 11.
However, testing rates have been low with about 810,000 performed in a country with a population of more than 200 million.
“The Covax facility will supply vaccines for 20 percent of the population,” said Adeyeye. “Nigeria will need to procure theirs from whichever company they want or whichever company NAFDAC certifies” to meet the needs of the rest of the population.
NAFDAC has introduced guidelines to accelerate the licensing of Covid-19 vaccines that have already been approved by regulators including the U.S. Food and Drug Administration or U.K.’s Medicines and Healthcare Products Regulatory Agency, she said.
The expedited review should take 15 days instead of several months, according to Adeyeye. WHO-approved shots will also undergo the fast-track process, she said.
Doses supplied by Covax are intended to enable participating countries to protect “their most vulnerable groups” starting with health care workers, a spokesman for Gavi, the Vaccine Alliance, which is heading the project with the WHO and the Coalition for Epidemic Preparedness Innovations, said by email.
The Covax program is negotiating the provision of vaccines developed by Pfizer Inc. and AstraZeneca Plc “so that poor countries don’t have to stand in line behind rich countries,” Gavi’s board chair, Ngozi Okonjo-Iweala, said on Dec. 9.
Covax hopes that inoculation will start in participating nations by the end of January, she said. Okonjo-Iweala is also an African Union special envoy for mobilizing resources for the continent’s fight against Covid-19.
While vaccine manufacturers are yet to submit applications to NAFDAC, Nigerian officials met with Pfizer several months ago, as well as the makers of Russia’s Sputnik V vaccine when they were starting Phase III clinical trials, Adeyeye said.
“We told them that until the data is very robust we cannot register their product or even start the process,” she said.
The Nigerian regulator hasn’t received any data on shots being produced by Chinese companies, in comparison to the information published by western firms such as Pfizer, AstraZeneca and Moderna Inc.
“We don’t know much about the vaccine from China,” Adeyeye said. “If it has been tested in the public arena, in the scientific arena, if it has been submitted to WHO, yes we will welcome any product from China.”