Brazil doubts Sputnik V vaccine, Russia calls for political solution

Could the Russian Covid-19 vaccine transmit another disease? This is what the Brazilian health agency (Anvisa) suspects, which opposes the use of Sputnik V on its territory. “We will never allow millions of Brazilians to be exposed to products without proper quality, safety and efficacy testing, or at least in the face of the serious situation we are experiencing, there is a favorable relationship between risk and benefit.”– said Antonio Barra Torres, President of Anvisa.

Russia condemns the political decision. “Anvisa’s delays in approving Sputnik V are unfortunately political and have nothing to do with access to information or science.”, we read on the account Russian twitter of vaccines

Sputnik V is already in use in several countries besides Russia, such as Mexico, Argentina or Venezuela. On the other hand, it is still not approved by the European Union (EMA) and US (FDA) health agencies.

The presentation, posted on the Anvisa website, details what the regulator is criticizing the Russian vaccine for. This is not an easy task. To understand, you need to know how this vaccine works. Sputnik V, like Johnson & Johnson or AstraZeneca, uses a different virus as a vehicle for delivering the Sars-Cov-2 genetic material responsible for Covid-19 to the human body. It is an adenovirus, a common virus that causes the common cold. Typically, the virus is inactivated to produce a vaccine: certain genes necessary for its replication are removed. In addition, specific genes for Sars-Cov-2 have been added to it.

Thus, adenovirus is able to infect a human cell and cause it to produce specific Sars-Cov-2 proteins, which are recognized by the immune system. But it cannot reproduce and infect other cells.

Tests by Anvisa showed that some of the samples contained adenovirus “Replication capability”so that it could still multiply after being introduced into the body. Faced with this problem, American virologist Angela Rasmussen believes: on twitterthat Brazil is right in refusing to use this vaccine, even though adenovirus infections are generally benign. These results “Raise Questions About Manufacturing Integrity” about this vaccine, she told AFP. This will be a quality control problem, not an inherent technology problem.

“Fake news” for the Russian laboratory Gamaley

At the beginning of the month, it was Slovakia that expressed doubts about this vaccine. “Vaccine lots [Spoutnik V] used in preclinical trials and clinical studies published in the journal Lancet do not have the same characteristics and properties as those imported to Slovakia “– said in a statement from the National Institute for Drug Control (SUKL), sent to the agency AFP. A month ago, Marie-Paul Keeney explained Release that Sputnik V EMA approval takes time because manufacturers “Many different subcontractors are used, making it difficult to harmonize vaccine production”… Obviously, not all subcontractors will be able to provide the same product quality.

The Russian laboratory Gamaleya does not recognize the problem and prefers to talk about it. “Fake news”… An attitude that American chemist Derek Lowe regrets in his blog post about Science Magazine, he asks them to act “As Responsible Drug Developers: Solve Problems Directly, Transparently and Work to Find a Solution”… Laboratory approves “Keep working with Brazilian states”… Seven of them appealed the decision to the Federal Supreme Court.

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