Regulatory agencies in Latin America continue to march ahead with COVID-19 vaccine approvals. Mexico’s COFEPRIS got the ball rolling when it authorised emergency use of Pfizer/BioNTech’s Comirnaty in mid-December. Argentina’s ANMAT was first with the AZ/Oxford vaccine.

As COVID-19 vaccination drives continue to get underway globally, the major regulatory agencies Latin America are jostling for position as the regional benchmarkers for the approval of the novel drugs.

The first to raise its hand was Mexico, on Friday December 11, 2020, when it authorised emergency use of the Pfizer/BioNTech vaccine just nine days after the first global approval was granted in the United Kingdom (on Wednesday December 2).

Although Brazil’s ANVISA is usually seen as one of the benchmark drug regulators in the region, as yet it has not authorised any vaccine against Covid-19. It is expected that it will be the first country in the region to approve the vaccine from China’s Sinovac, which has submitted an application through the Butantan Institute. It is also expected to approve the vaccine from Britain’s AstraZeneca, submitted through the foundation Fiocruz.

One national agency that wanted to stand out was Chile’s Instituto de Salud Pública (ISP), which despite being an agency with normally little impact was ahead of Argentina in giving the OK to the Pfizer vaccine on Thursday December 17. The Agencia Nacional de Regulación, Control y Vigilancia Sanitaria in Ecuador also granted the go-ahead just a few hours later.

Argentina’s ANMAT, led by Manuel Limeres, officially granted emergency approval of the same vaccine in the run-up to Christmas on December 22. Finally, Colombia’s INVIMA granted the vaccine emergency approval this past week, on Tuesday, January 5. See article.

It’s the only COVID-19 vaccine that Colombia has approved to date. Meanwhile, as well as Brazil, there are several countries in Latin America that have yet to approve any vaccine.  including Paraguay, Peru, and Uruguay.

Despite Pfizer gaining the edge internationally with its early approvals, it’s believed the vaccine from Britain’s AstraZeneca and the University of Oxford is more relevant for Latam due to the agreements forged between several countries and the Mexico-based Slim foundation.

Argentina’s ANMAT led the field giving the green light to the vaccine just a few hours after the Medicines and Healthcare products Regulatory Agency (MHRA) in Great Britain on Wednesday, December 30. See article on the MHRA’s approval

It’s seen as a strategic vaccine for Latin America since its active component will be manufactured in Argentina by the local drugmaker mAbxience, owned by Hugo Sigman. The packaging process will be completed in Mexico by Liomont. From Mexico, the vaccine will be distributed to the entire region minus Brazil.

Mexico was the second country in the region to approve the AstraZeneca and Oxford vaccine. COFEPRIS granted the approval on Monday January 4.

For now, the major regional regulator that’s remained notably quiet is ANVISA in Brazil. The agency, which in mid-December determined a 10-day period to respond to applications for the approval of COVID-19 vaccines, has yet to grant any emergency use authorisations. 

Today, Friday January 8, the Butantan Institute has submitted a request for authorisation for CoronaVac, from China’s Sinovac. ANVISA has stated that it is evaluating its approval, which means the Sinovac vaccine could be the first to obtain the go-ahead in Brazil. The approval of AstraZeneca’s Oxford vaccine is also believed to be in the works. The British drugmaker has an agreement with Brazil’s Fiocruz foundation, but there is yet to be any official word.

Finally, the vaccine from US-based Moderna could also now gain momentum in the region following its approval by the UK’s MHRA today. It was already approved by the US FDA and in Puerto Rico in December. Both Mexico and from Chile have the vaccine in their sights. 

Sputnik V in Latin America 

Another vaccine gaining strength in the region is Sputnik V developed by the Gamaleya National Center of Epidemiology and Microbiology in  Russia

Argentina, which had been interested in the vaccine from the outset, became the first country on the continent to grant it emergency use approval the day before Christmas Eve. The endorsement came directly from the Ministry of Health since the remit of the regulator, ANMAT, only covers regulated companies. See article in Spanish.

Bolivia followed in Argentina’s footsteps, becoming the second country in Latin America to authorise Sputnik V when the AGEMED granted emergency use approval two days ago without requesting additional clinical trials in the country.

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