By Thomas Neuburger
The vaccine news is filled with reports of the first two candidates to apply for FDA emergency use authorization (EUA) — Pfizer's, which has just been approved in the U.S., and Moderna's which is like to be approved soon. Both are mRNA products, which means they introduce human-created genetic code ("messenger RNA") into your body that teaches your cells to make and express the spike protein that's also present on the surface of the Covid virus. When the body sees this spike protein, it starts developing anti-bodies against it.
A third vaccine has also been in the news. The Oxford-AstraZeneca candidate introduces a genetically modified virus into the body that already carries the spike protein. This also stimulates an immune response, similar to the response stimulated by the two other major candidates.
There are several lenses through which to view all Covid vaccine candidates:
Amount of testing (no vaccine is well tested at this point)
Length of time for which immunity is conferred: A month? a year? two years?
Safety, and severity of side effects
Source funding of the research: Moderna took half a billion dollars from the U.S. government for research; Pfizer took no U.S. government money; AstraZeneca took an unspecified amount.
Plans to profit from the vaccine vs. providing it at cost
Plans to keep the technology private vs. putting it in the public domain
Political considerations: Was the vaccine developed in a country we don't like? Through lobbying, are any of the manufacturers able to cut deals to increase their income and profit?
About the last item, the federal government has reportedly said it will make the vaccine available for free. But how much will our government pay the manufacturers per dose — quite a lot, as a monetary reward for public service and/or political support of the new administration; or near cost, as a way to redirect (supposedly scarce) government money to other problems, such as the massive economic disaster we're about to witness?
Two Vaccines Below the American Radar
Two Covid vaccine candidates are not on the radar of most Americans, since they're not covered in the U.S. broadcast media. One is from Russia — yes, media-hated Russia. The other is from Israel. The Russian says it plans to make its vaccine available worldwide. The Israelis are creating their vaccine for domestic (Israeli) use only, at least for now.
I'm fascinated by both of these products since they differ in so many ways (including cost) from the main ones currently touted. The Russian vaccine is especially interesting, both medically and politically, as you'll see below.
Here's are short news items about each. This is not a thorough examination; I just want to put them your radar as you evaluate all vaccine products that become available. You'll also note, in these news briefs, comments by the developers on the strengths and weakness of their competitors.
The "Russian Vaccine"
The so-called "Russian vaccine" is produced by the Russian government agency responsible for vaccine development. Last September the British medical Journal The Lancet spoke quite well of it. If it proves effective and safe, will the Democratic Party-led U.S. government and its attendant media denigrate the product as "Putin's vaccine" and discourage its use? Will the U.S. refuse to certify it? The answer to those questions will be interesting in themselves.
Here's a report on this vaccine from the Russian news agency Tass (emphasis added):
Sputnik V likely to offer two-year protection against coronavirus - developers
Gintsburg explained the criticism of Russia’s Sputnik V vaccine by unfair market competition and political motives
MOSCOW, December 12. /TASS/. Russia's Sputnik V vaccine is likely to offer two-year-long protection against the novel coronavirus, said Alexander Gintsburg, the head of the vaccine’s developer, Gamaleya National Research Center for Epidemiology and Microbiology.
"So far, I can only make suggestions, because more experimental data is needed. Our vaccine was created on the platform also used for the Ebola vaccine. Experimental data received at that point demonstrate that a similar vaccine would offer protection for two years, maybe more," he told the Soloviev Live channel on YouTube.
According to the Russian scientist, Sputnik V is effective in 96% of cases. The remaining four percent of vaccinated persons will have a mild form of the disease with runny nose, cough and slight fever, but lungs won’t be affected.
Gintsburg explained the criticism of Russia’s Sputnik V vaccine by unfair market competition and political motives.
"The first reason is that <...> the market for this vaccine amounts to tens, maybe hundreds of billions of dollars. <...> Corporations and people, who are behind all this money, fight for the profit. And <…> no holds are barred here," he said.
The other reason are political motives, Gintsburg continued.
"As we could witness not so long ago, a group of vaccine researchers almost played a crucial role during elections in one country on the American continent. <...> All together, they announced that they had created a vaccine three or five days after the elections were over. <...> Before that, the vaccine was not yet ready," he said.
Registered by Russia on August 11, Sputnik V became the world’s first coronavirus vaccine. The vaccine was developed by the Gamaleya National Research Center of Epidemiology and Microbiology. Its post-registration trials began in Moscow on September 7, with volunteers receiving the first vaccine on September 9. A total of 40,000 people are involved in the program, 10,000 of them received a placebo instead of the vaccine.
According to interim research results, the efficacy of the Sputnik V vaccine exceeds 95% on the 42nd day after the first dose, provided that a patient receives the second dose.
On December 2, Russian President Vladimir Putin ordered to organize a nationwide vaccination starting by the end of this week. As Prime Minister Mikhail Mishustin added, the inoculation should be completely voluntary and free of charge, with teachers, medics, and social workers receiving the vaccine first, while the regions can expand this list.
About vaccine "efficacy," see this. 95% may not mean what you think it means.
The "Israeli Vaccine"
Israel has also developed a vaccine, but for its own use for reasons of safety and supply. This is from a report in the Jerusalem Post (emphasis added):
Hadassah research head raises questions about mRNA vaccine safety
Prof. Yossi Karko explains Israel’s vaccine candidate, questions efficacy of Russia’s Sputnik V
By MAAYAN JAFFE-HOFFMAN DECEMBER 1, 2020 20:33
Prof. Yossi Karko, director of the clinical research unit at Hadassah-University Medical Center, has warned that the data published by Moderna and Pfizer about their coronavirus vaccine candidates is limited.
Both companies have applied for Emergency Use Authorization (EUA) from the Food and Drug Administration for their vaccines but Karko, who has been overseeing the clinical trial of Israel’s vaccine at Hadassah, said that “while they seem to be very efficient vaccines, we have to remember that this data has shortcomings.”
First, he told The Jerusalem Post, the [Moderna and Pfizer] data only tracks volunteers for one month following vaccination. While he said that “it really protects subjects quite well now,” questions remain about what happens next month and the month after.
“We do expect that the vaccine will protect us for a longer period of time, but this data is not available,” he said.
Second, Karko noted that the safety data is “very short” – only spanning the period of about two months from inoculation.
“The FDA has a mechanism of approving drugs and vaccines for emergency cases. What this means, is that the FDA has initial safety data. But if this was a usual situation, the researchers would have followed the volunteers for at least two years before the vaccine was approved,” he said.
“We need to know these reservations,” Karko said. “These things are new. There are concerns and we have to be very careful.”
He emphasized that he is not saying the vaccines are “not excellent or terrific,” but just that “we should be aware of the limitations of the data.”
IN CONTRAST to the mRNA vaccines, Karko said that Israel’s Brilife, which was designed by the Israel Institute for Biological Research, is a vector-based vaccine. The vaccine takes the virus vesicular stomatitis virus (VSV) and genetically engineers it so that it will express the spike protein of the novel coronavirus on its envelope. [...]
Phase I of the IIBR study was completed last week and Phase II is expected to launch in the next two weeks [i.e., the first two weeks of December].
“Up to now, there are no safety concerns,” Karko said. “We are very happy with the results.”
When asked why the institute would not aim for FDA or even European Medicines Agency approval, Karko said that “IIBR does not have presumptions to produce a vaccine that is going to be commercialized. The objective is to produce an efficient and safe vaccine to serve the citizens of Israel.”
And what about Russia’s Sputnik V vaccine, which Hadassah is vying to manufacture in Israel?
“It is a well-developed vaccine,” he said. But he admitted that the clinical process of evaluating the efficacy of the vaccine could be “deficient.”
“Until I see a publication with scientific data that has undergone peer review, I cannot really comment,” Karko added.
A lot to think about as we sail the vaccine waters.