From Republic.ru, Dec. 7, 2020, complete text:
The news of the first week of December already read like a frontline bulletin, and the situation keeps changing almost daily. Last Monday [Nov. 30], the pharmaceutical company Moderna announced that its vaccine is 100% effective against “severe COVID-19.” Of course, the Moderna press release merely stated that as of Nov. 30, the 30 people in the trial who developed severe COVID had received the placebo, not the vaccine, while of the 11 people who contracted [COVID] after being vaccinated, not a single one developed complications. It’s clear that subsequent observations of vaccinated people will show different effectiveness results. [Vaccine] developers from the Gamaleya Institute of Epidemiology and Microbiology would have liked to brag about an even better result, but since that’s impossible, they had to make do with their earlier statement that their vaccine is “more than 95% effective.”
Then on Wednesday, Dec. 2, Great Britain’s Medicines and Healthcare Products Regulatory Agency (MHRA) gave temporary approval for the emergency use of a genetic vaccine created jointly by Pfizer and BioNTech. BioNTech’s [sic; Pfizer’s] press office reported that an agreement to supply Britain with 40 million doses of the vaccine has already been signed.
Naturally, Russian President Vladimir Putin could not allow anyone to steal his self-appointed title as savior of the world from a perfidious virus: During a cabinet meeting that same day via videoconference, which has become the customary format by now, he ordered the start of [mass] vaccinations in Russia. According to Putin, the volume of production for the Sputnik V vaccine, developed by the Gamaleya Institute, will reach millions of doses in the coming days, which will allow [Russia to start] “at least a large-scale vaccination campaign if not mass [vaccinations].”
Putin gave the order on Dec. 2, and a vaccination sign-up list appeared on Moscow City Hall’s official Web site on Dec. 4. More than 70 vaccination centers opened in Moscow on Dec. 5, and this week vaccinations will also kick off in the regions, Deputy Prime Minister Tatyana Golikova announced during a Dec. 4 government briefing. . . .
‘Popular research’ and ‘informed sources.’
The Health Ministry registered the vaccine developed by the Gamaleya Institute, called Sputnik V, back in August, before the start of the third and most important stage of clinical trials [see Vol. 72, No. 33, pp. 13‑14]. After getting it registered, the vaccine’s developers stopped making any kind of public announcements about its testing. Sometimes, they passed on bits of information to officials, so that the latter would have at least something to report publicly about the vaccine, since the public is about to be vaccinated en masse. A few days ago, Deputy Moscow Mayor Anastasia Rakova told Rossia 24 [TV channel] that 273 participants in Sputnik V phase 3 trials have gotten sick [with COVID‑19]: “More than 20,000 people have already received both doses of the vaccine as part of its postregistration clinical trials. As of today, only 273 have gotten sick. That is 1.5% of all those vaccinated.” In light of this, the deputy mayor (but not the vaccine’s official developer) concluded that “these figures speak for themselves about the vaccine’s effectiveness.” At the same time, when announcing the vaccine’s success, the authorities don’t know who got the placebo and who got the vaccine among the people who got sick. Apparently, Rakova is also unaware that you can’t draw any conclusions about the vaccine without this information. . . .
But as the “large-scale vaccination campaign” kicked off, previously unknown details from informed sources (mostly anonymous ones) started being leaked to the media.
For instance, “an informed federal official and a pharmaceutical industry source” told Meduza that Russia has only 500,000 doses of the Sputnik V vaccine – not 2 million, as Putin said. Another interesting tidbit is that while manufacturers have already ironed out all the glitches with producing the first dose of the vaccine, they are still experiencing problems with the second dose. The second dose turned out to be “more finicky” so its production has been suspended. This created a “paradigm shift”: While volunteers used to be injected with the second dose exactly 21 days after the first, now “it turns out that it’s unnecessary to do the second one after exactly 21 days, and the interval can be anywhere from 21 to 50 days,” another informed source told Meduza. . . .
Choosing between two evils.
Lev Averbakh, general director and chief physician of CORIS private ambulance service in St. Petersburg, believes that “rolling out vaccinations at the peak of an epidemic of the disease that people are being vaccinated against is a huge mistake” that goes against the tenets of epidemiology. He posted that on Facebook. His post became very popular, especially among colleagues.
Lev Averbakh explained his position in more detail to Republic’s [online magazine] Vlast [Power]: “Generally, the goal of vaccination is to create antibodies that will fight infection when they encounter a foreign pathogen. However, during an epidemic, a lot of people contract [the infection], so a lot of people have already had the disease, many asymptomatically. This means that many people already have antibodies, and generally, people should be tested for antibodies before being vaccinated, because if someone already has antibodies, there is no reason to vaccinate them. Indiscriminately vaccinating everyone, and thereby adding antibodies [to people who already have them], is wrong, because there have been paradoxical cases (the so-called antibody-dependent enhancement – Ed.). If someone who already has antibodies gets the vaccine, that could provoke an unpredictable reaction. So we shouldn’t vaccinate those who already have them [antibodies]. However, doing this (antibody testing prior to vaccination – Ed.) is very expensive, so no one is going to do it.” . . .
Lev Averbakh also raises questions about recent statements by government officials that the vaccine does not create full immunity to COVID‑19 until 42 days after the first injection. According to him, “Forty-two days is a very long time. That means that either someone has to be placed under observation that whole time, or the vaccine is worthless. No one knows what will happen if someone contracts the infection in those 42 days and is in contact with others, because it’s impossible to track this from a distance. That is why age restrictions were introduced for the vaccination – only those between the ages of 18 and 60 are getting it. But it’s those older than 60 who are most at risk of infection.”
Prof. Pavel Vorobyov, Doctor of Medicine and chairman of the Moscow Scientific Society of Physicians, called Putin’s large-scale Sputnik V vaccination a disaster. He posted on Facebook: “The vaccine creates immune complications in at least 15% of cases. And this is in those who have not contracted [COVID‑19]. But what will happen to those who have already had it? The order has been given, and in a week we will start vaccinating doctors and teachers. But most [doctors] have already contracted COVID in one form or another, and as we know, antibodies disappear after 1.5 months, so proving that you’ve had it is impossible. So [are they just supposed to] submit themselves to this slaughter and wait for autoimmune complications?”
Many doctors don’t share the opinion of Lev Averbakh and Pavel Vorobyov. For instance, Olga Matveyeva, a microbiologist from the US, says she believes in [COVID] vaccines, including Sputnik V.
“It’s alarming that vaccine testing was rushed, but I am more afraid of contracting the virus than getting a vaccine that has not undergone all testing,” she said. . . .
“Antibody-dependent enhancement (ADE) is so far only a theoretical complication from the vaccine, but it is just as likely from reinfection in those who have recovered. This means that ADE is possible with any secondary contact with a pathogen: both after vaccination, and after reinfection. Vaccines could play some nasty trick. There may be delayed side effects, such as ADE, but in my opinion, there is more chance of an unvaccinated person getting infected and developing complications. We are choosing the lesser of two evils. I used to think that the infection was better than the vaccine. However, I’ve changed my mind after seeing how often there are complications. I understand the risks of vaccines perfectly well, but I have read about too many cases of long-term complications from COVID. For me, COVID is worse than the vaccine,” Olga Matveyeva said.
On Dec. 5, Reuters reported that government employees in Moscow are being forced to get the Sputnik V vaccine. According to the source, staff at Moscow Clinic No. 3 have been told: “If you refuse to get vaccinated, you could be suspended from work. There is a legislative basis for this.” “Our clinic has been issued with a compulsory anti‑COVID‑19 vaccination order for all employees. This is being supervised by the Moscow health department,” Reuters wrote, citing deputy chief medical officer Olga Tsvetkova’s message to clinic staff.
The Alliance of Doctors, an independent trade union, appealed to Russian medical workers through social networks: “Many of you are being pressured to get the COVID‑19 vaccine, which has not undergone all the necessary clinical trials to ensure safety and effectiveness. Each one of us is, of course, responsible for our own health and the health of minors. But that is why it’s important to understand that no one will be held responsible for serious complications, which have already been discovered among medical staff inoculated with the untested vaccine.
“We understand the authorities’ desire to reduce the burden on the health care system at the peak of a pandemic. But that must not come at the expense of risking your health or your freedoms, or through violating the law and coercing you to participate in medical experiments that the Russian government is conducting on its own people.
“The Alliance of Doctors independent trade union has the following demands. [The Russian government] must:
– comply with existing Russian legislation and international law;
– observe the rights of medical workers, and the rights of all citizens of the Russian Federation;
– immediately cease psychological pressure and coercion of health care workers and other population groups to get the vaccination.
“Everyone must freely decide whether to test this vaccine or to refuse.” . . .
Fear is a bad counselor.
Russia’s Sputnik V is a pig in the poke. Originally “copy-pasted” from four of the Gamaleya Institute’s vector vaccine developments that were never completed, it never underwent clinical trials, and we know almost nothing about it. In fact, we may never learn anything, since the reason it was created and promoted was so that Putin could tell the whole world that Russia was the first to register a COVID‑19 vaccine, and the first to start inoculating the population. So Sputnik V should not be regarded as a serious medical development; it was a purely political project carried out by unscrupulous scientists together with unscrupulous politicians.
Other vaccines that are currently undergoing phase 3 trials (the vaccines being developed by Pfizer/BioNTech, AstraZeneca, as well as several vaccines from Israel, the European Union and the US, which are approaching phase 3 trials) inspire more confidence due to their openness, transparency and reliability. But currently, we don’t know enough even about those vaccines. This is a clear problem, since each vaccine has undergone no more than three months of clinical trials, and no one knows what may happen down the line, what complications could arise, or how the vaccines will fare if used on a mass scale on various segments of the population. . . .
Perhaps we should focus more on preventing the spread of infection, establishing quarantine measures and searching for medication that could treat COVID‑19 complications, instead of rushing to launch vaccines that lack thorough safety testing?
The Bulletin of the Moscow Scholarly Society of Physicians recently published an article stating that after analyzing the restrictive measures taken by 131 countries, an international group of scientists concluded that the most effective restrictions included canceling mass events; closing bars, restaurants and schools; and transitioning to remote work. This shows that introducing moderate and reasonable restrictions to prevent people from gathering in large groups indoors, as well as adhering to basic sanitary norms, is enough to significantly reduce the spread of the airborne infection.
By following these steps, we could wait until the vaccines undergo all the necessary testing and become truly safe and effective.
Fear and panic make bad counselors. It’s time to stop succumbing to them and use common sense to recall long-established epidemiological practices.