Vladimir Putin, the President of Russia, has announced that Russia has approved a new Covid-19 vaccine, called “Sputnik V”. The vaccine successfully completed Phase II trials, which are for safety and effectiveness. But the effectiveness is only shown in that the vaccine caused the immune system to make antibodies. It is not until Phase III trials that a vaccine is tested to see if it actually protects against infection from the virus. No Phase III trials have yet been completed, and yet the government has approved the vaccine. It seems highly unlikely that they are omitting Phase III trials, as the data from those trials would be very useful. So they are simply releasing the vaccine for use before Phase III trials are completed.
Phase II trial: the vaccine is given to a group of persons. There is no placebo. They note any side effects. Sometimes they test different dosages of the vaccine. And they test the blood for the development of antibodies. Putin has said that his adult daughter has participated in a Phase II trial. If the Phase II trial was successful, as Putin said, then the side effects were tolerable and the vaccine caused sufficient amounts of antibodies to be produced.
Why is the vaccine named “Sputnik V”? Sputnik is the Russian word for satellite. In this case, the word is apparently used to reference Russia success in launching the first satellite. And now they have the first Covid-19 vaccine. Therefore, Sputnik, in a sense, means “we’re first again”.
The vaccine is the “adenoviral vector” type, which uses a virus that causes the common cold to carry the proteins that cause the immune system to produce antibodies, and, in the case of adenovirus-type vaccines, T-cells as well. Adenovirus type vaccines elicit a strong T-cell response, in addition to antibodies, and so it is expected that this type of vaccine will be very effective, more so that other types perhaps.
The technology to make adenoviral vaccines has been around for 30 years, but there are currently no vaccines for humans on the market using this technology. The only one available right now is a rabies vaccine for animals. Why isn’t it used more often, if it causes a large immune system response? An early attempt at making this type of vaccine caused the death of one teenaged boy whose body reacted to the vaccine with excessive inflammation which caused his death [ACS publications].
Why did Russia choose this technology over more common methods of making vaccines? Likely because it is safer than a live-attenuated vaccine (like one being developed in India) and killed virus vaccines (which might have some non-killed viruses in a dose). Another reason is that this type of vaccine is believed to be highly effective against the virus. It is an aggressive choice to fight a figuratively-bloody war against a terrible opponent.
The way the vaccine is made is that a fairly harmless virus, which causes colds, called an adenovirus is genetically modified. The gene for the Covid-19 Spike protein is inserted into the code. However, since the Covid-19 virus (called SARS-CoV-2) is an RNA single strand virus, and adenoviruses are double stranded DNA, the researchers must first convert the RNA code into DNA, which they do with an enzyme known as reverse transcriptase. Then they insert the DNA into the genome of the adenovirus. They also removes some genes from the virus to prevent it from causing a respiratory illness (a cold). The genes for the Spike protein then cause this modified adenovirus to make Coronavirus type Spikes on its surface. These Spikes then are recognized by the immune system and cause the system to make both antibodies and T-cells that will recognize the Coronavirus and attack it, if the person becomes infected in the future.
It seems simple, but it is actually very complex and a lot of things can go wrong. The actual Spike protein is glycosylated, and the adenovirus Spikes might not be. This makes the vaccine Spikes different enough that many of the antibodies might not work on the real Coronavirus as that part of the protein may be covered by the sugar chains (glycosylated proteins have chains of sugars attacked). Also, the Coronavirus (Covid-19) has several ways of attacking the immune system, and that is not addressed by a vaccine.
A better solution would be vaccine plus prophylactics, including viral inhibitors which interfere with the viral components that attack the immune system. Vitamin D is also crucial to strengthen the immune system and also inhibit the virus. This disease is so severe that there can’t really be just one pill or one treatment that will work to defeat the disease alone. We need multiple vaccines, multiple prophylactics, multiple treatment modalities, and more research on longhaulers.
Perhaps the West should follow the lead of Russia and begin using the vaccines that have completed Phase II trials successfully.
Ronald L. Conte Jr.
Note: The author of this article is not a doctor, nurse, or healthcare provider, and this article does not offer medical advice.