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.

Tucker Suckers

Tucker Carlson, Fox News Commentator

We are in a global war against the Covid-19 Pandemic. The safety and effectiveness of the vaccines at this point has been clearly been proven. It is a fact that those countries who have be able to acquire and distribute the vaccines to a high percentage of their populations are seeing the new incidences go dramatically down. It is also a fact that there have been extremely few severe reactions, on the order of one in a million. Over a billion vaccines have been administered worldwide. Medical workers and doctors got first in line with when the shots were available. Every living current and past president have been vaccinated.

Tucker Carlson. with Fox News, is not a journalist. He is a showman. Tucker Carlson promotes doubt rather than fact. This lets Fox News make more money. When he raises a long series of questions, it’s like a cliff hanger- tune in tomorrow as only Tucker can dig down and finally uncover the truth. It’s show biz!

He went way too far with several broadcasts on the vaccines in support those hesitant to be vaccinate. He claimed many more people are have severe reactions or die after taking the vaccine than reported in the mainstream media. Actually, as pointed out by the excellent reporting in the Washington Post, his statistics are just plain wrong because he is using a database, where anyone can report adverse reactions, and the connection to the vaccine is not verified.

This should not be political. Operation Warp Speed was responsible for the rapid development and distribution of Covid-19 vaccines under the Trump administration. Two Covid-19 vaccines were approved for Emergency Use by the FDA under the Trump administration. Trump and his family were vaccinated in January 2021, soon after the vaccines were approved.

Carlson speaks with great conviction. His facts are wrong. And those who watch and believe him, and don’t get vaccinated, may help in the continued spread of the disease. This followers should know better. I call them Tucker suckers, but perhaps Tucker victims is a better term, as some will get Covid-19, end up in the hospital, with very dire consequences, including death.

I know commentators want to impress their audience with “Breaking News,” not heard on other cable news stations. Well there is a reason in this case. Tucker facts are misleading or wrong. Others including commentators on Fox News, have recognized how extreme and reckless his broadcasts have become.

See further support in the links below. I know links from Washington Post may require a subscription, but they frequently allow some free views. CNN response is excellent.

Stay tuned,

Dave

Links:

Washington Post More than 3,283,000 people have died from the coronavirus worldwide

Washington Post, Tucker Carlson’s worst vaccine segment yet

CNN, Tucker Carlson’s Fox News colleagues call out his dangerous anti-vaccination rhetoric

John Oliver on HBO, Humorous as always, but I think he’s right on the mark May 3, 2021, but didn’t stop Tucker Carlson, with more broadcasts.

May 3 broadcast

Why You Should Get Vaccinated

Covid-19 is a worldwide killer and vaccines are the answer, if everyone does their part. Let me tell you why.

The Covid-19 vaccination program began in December 2020 with Pfizer and Moderna vaccines. The supply was very scarce and the demand was very great. There are a lot of people in great health who have died of Covid-19. They ate well, took care of themselves and have no idea where they got the virus. Frontline medical professionals have died from Covid-19. In some cases, their immune system went into overdrive, and they didn’t pull through.

I’ve heard plenty of people feeling the after effects of Covid-19, including weeks without being able to taste food and respiratory problems.

Worldwide we just past the 1 billion doses of vaccines being administered. We still have a long ways to go. In the US and other countries, health professionals are monitoring the effectiveness of the vaccine. They don’t work for the drug companies. They have found that the vaccines are working, even against the various new strains. However, for the 2 shot vaccines, the second shot is really necessary to get the full benefit of the vaccine.

I’ve heard now, a few reasons why not to get vaccinated. The first is that it might actually cause you to get coronavirus, as they are injecting a weaken virus into your system. This is totally false. They are injecting strands of DNA which generate anti-body cells to defend the body against Covid. Second, the vaccines are not 100% effective. This one is true, but I’d say, 95% effective is pretty good to me. There will never be a perfect vaccine.

I heard a commentator state that the elderly are dying from Covid and the youth are spreading it. Well, yes and no. A third of the elderly population is unvaccinated, and they certainly can be spreading it. And within the US, there are 2,300 young adults (under age of 30) who died of Covid-19. It is sad, but now it is also preventable.

Covid-19 is a worldwide killer and vaccines are the answer, if everyone does their part. End of sermon.

Stay tuned,

Dave

Press Briefing with Dr. Fauci