Brazil firm to produce Covid-19 vaccine for export

Hospitals in Brazil and India are filled to capacity. In Brazil, the number of new cases is about 61,000 (7-day rolling average). It is the last place you would expect vaccines to be produced for export to other countries. So, I would say the Covid-19 crisis in Brazil is terrible and a bit bizarre.

Brazil’s Anvisa agency rejected the Sputnik V vaccine developed by Russia’s Gamaleya Research Institute. Anvisa in Brazil is like the FDA in the US, as it must approve all vaccines. Brazil was expected to receive 30 million doses.

Yahoo news reports, “União Quimica’s facility in São Paulo has been certified by Anvisa for good production practices and the Gamaleya vaccine will be made for export to countries that have approved it, said CEO and founder Fernando Marques.” I suspect the vaccine will be shipped to Mexico and Argentina. It is approved in India, and I’m sure they can’t wait to receive additional shipments.

The vaccine is claimed to be 91% effective. The Russian vaccine has been approved in 62 countries. The vaccine was really the first one to be approved, in August 2020, beating out Moderna and Pfizer. Russia was criticized for giving approval without sufficient Phase III trials, where the effectiveness could be reviewed by scientists around the world.

The European Medicines Agency is currently inspecting the manufacture of the Russian vaccine in Europe. I believe the Agency will give approval shortly, and this will make it easy for all European countries to approve.

The Russian vaccine is an Adenovirus vector vaccine, as are other approved vaccines: J&J, Oxford/AstraZeneca and Cansino. In the manufacture of the vaccine, the DNA of another virus (not Covid) so it can not replicate, but is capable of eliciting an immune response. The link below describes the vaccine as containing viral particles, which invades the cells and passes on specific instructions to the cells to build spike proteins. So these cells have enough in common with Covid, to get the immune system to defend against Covid. Very clever these scientists.

Anvisa rejection seems based more on the manufacturing of the vaccine, rather the science behind it. They claim that the batches of vaccine they examined contained replication-competent adenovirus. I’m stopping right here, because the scientists can battle this one out. It may be that some people getting the vaccine will have a mild cold, but they will nevertheless be protected from Covid.

The proof is in the pudding, as the saying goes. In Latin America, Mexico and Argentina have administered about 7 million doses, while over 12 million people in Russia have received the shot (see link from Wall Street Journal).

Anvisa was forced by a Supreme Court decision to rule on the requests of 10 states in Brazil for the vaccine. It is becoming increasingly apparent that the right wing politics of President Bolsonaro is a real element with this regulatory agency. They have no problem with approving toxic agricultural chemicals, which are banned in Europe.

Bolsonaro claims to be doing everything in his power to combat Covid-19. The solution is not with hydroxychloroquine or even worse ivermectin, but effective vaccines.

It is an appalling contradiction when millions of doses of Gameleya’s vaccine are made in the populous city of São Paulo (11 million residents) and shipped to other countries, when there is a dire need for more vaccines at home. The question remains- has Anvisa dug themselves a hole too deep for themselves get out of? I hope not.

This is a continuing story and I’ll update it as information is available.

Stay tuned,

Dave

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Links:

Yahoo News: European Medicines Agency experts beginning Sputnik V manufacturing inspections: Official

Science Magazine Blog: Brazil Rejects the Gamaleya Vaccine

Wall Street Journal: Brazil Defends Decision to Reject Russia’s Covid-19 Vaccine, Citing Safety and Efficacy

Brasilwire: With 400,000 Dead, Brazil Regulator Slammed For “Political” Veto Of Russian Vaccine

Bolsonaro advocates freedom (forget lockdowns and social distancing- and still promotes hydroxychloroquine!)

Why You Should Not Use Ivermectin to Treat or Prevent COVID-19 from US FDA.

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