CAJICA, Colombia – Countries in Latin America have joined those in Europe expressing mixed reactions about continuing their vaccination plans with the AZD-1222 SARS-CoV-2 vaccine developed by Astrazeneca plc and the University of Oxford, following reports of alleged adverse events.
“Venezuela will not give permission for the Astrazeneca vaccine to be used in the immunization process of our population, due to the situations and complications that have been presented by those who have been vaccinated with this vaccine,” said Delcy Rodriguez, vice president of Maduro´s regime in Venezuela.
“President Nicolas Maduro has decided, taking into account the technical reports presented by the experts´ committee, to not approve and to not license this vaccine in the Venezuelan territory," she explained.
Along with Venezuela, the government of Paraguay also will not receive or use Astrazeneca vaccines, but said that the decision is limited to those manufactured in Europe.
The country is open to receive and use Astrazeneca vaccines manufactured in other locations like South Korea, according to Julio Borba, ministry of health of the South American nation.
Moreover, Borba announced on March 17 that the country will use a quota of 2 million doses of Astrazeneca vaccines transferred by Taiwan to Paraguay.
“We are finishing all the pertinent documents... there are negotiations with the company in the U.S., through the Embassy of Taiwan in Washington... Apparently, we would be the third country that buys this vaccine directly with the representative of the company,” he said.
Meanwhile, neighboring Brazil already started the production of AZD-1222 out of Fiocruz´s plant in Rio de Janeiro. It is expected for Fiocruz to manufacture up to 222 million doses of the vaccine in 2021.
“The first line in operation today is producing about 300,000 doses per day,” said Fiocruz, which started its manufacturing operations of the vaccine on March 9. “The expectation is to arrive by the end of March, with both lines in operation, with a production of around 1 million doses per day,” it added.
Andre Lobato, a PhD candidate in economics and an adviser of international cooperation, working closely with the Brazilian biotech sector, told BioWorld that Fiocruz´s move will create new and better opportunities for the Brazilian life science sector.
“Fiocruz´s production of an IFA from adenovirus for a coronavirus is a good opportunity not only for the National Inoculation Program, but broadly for all research programs that can take advantage in the field,” he said. “It's a big day for an institution that is much loved by the Brazilian people.”
For his part, Daniel Dominguez, co-founder of Allbiotech, the Latin American Network of Biotechnology, a nonprofit headquartered in Mexico City that aims to promote the development of the biotech industry, told BioWorld that the region is too invested in the Astrazeneca vaccine to push it back, no matter what foreign regulators say.
“Such was the commitment to this vaccine in the region that, not using it, would put the Latin American region at a point where, to start, we are going to have to store a number of doses that in theory are already there and then we are going to fall short in vaccines, and these countries already have their shortages,” he said while talking about the situation of the vaccine particularly in Brazil, Argentina and Mexico.
The latter two countries are manufacturing together the AZD-1222 vaccine, but have not been successful in distributing it.
‘We don’t have overstocks’
The vaccines´ active ingredients are produced by Mabxience SA, from Buenos Aires, Argentina, and are shipped to a plant from Liomont in Mexico City, where they are supposed to be packed and distributed. However, a shortage of vials and regulatory issues in Mexico are delaying the distribution of the Astrazeneca vaccine made in Latin America.
As Mexico waits for the manufacturing and distribution of the Astrazeneca vaccines´ bottleneck to be solved, the country keeps using a batch of 870,000 doses manufactured by the Serum Institute of India, from Pune. It was also successful in negotiating with Washington D.C., the transfer of a batch from the U.S. containing 2.5 million doses of the AZD-1222 vaccine.
“The agreement with the U.S. gives priority to Astrazeneca to ensure the second dose of 870,000 elderly who were vaccinated in February. It's about 2.5 million doses. It would be the best start for a broad cooperation on vaccines. We continue working, we will conclude at night,” Marcelo Ebrard, Mexico's secretary of foreign relations, tweeted on March 18.
For Dominguez, the bet on Astrazeneca´s vaccine in Latin America was so big, that it is impossible to discard those vaccines and the more the region can get, the better. “We don't have overstocks like countries in other regions, to be able to get rid of COVID-19 vaccines at this time,” said Dominguez.
Meanwhile in Colombia, authorities said to be evaluating what European authorities had to say about the vaccine. A batch of 244,000 Astrazeneca vaccines is set to arrive in the Latin American country via the Covax mechanism, by the end of the month.
On March 18, the EMA said that benefits of the AZD-1222 vaccine outweigh the risks, “despite possible link to rare blood clots with low blood platelets.”
“The committee was of the opinion that the vaccine’s proven efficacy in preventing hospitalization and death from COVID-19 outweighs the extremely small likelihood of developing DIC or CVST,” the regulator explained.