Disclaimer:
The article was written out based on the writer's personal research about the said issue/s raised. Heads up as well, this is a long article.
Months ago, we were baffled by a huge announcement from Russia as news around the world continue to come about the first ever registered COVID-19 Vaccine. There are a lot of skeptics about this vaccine that includes our country as we will participate on the clinical trials to be done for Phase III. As this vaccine gets more attention, more information surfaced that causes misinformation about it which some of our countrymen are easily to be believed such as this vaccine is considered to be massive human experiment. You can't blame others as they are now comparing every vaccine to the controversial Dengvaxia as always but let us dig deeper about this vaccine.
There are reports that the new vaccine has adverse reactions but it also provides protective antibodies. This alone caused skeptical thoughts not just on civilians but some on medical community, however, this does not mean that the vaccine necessarily works or the other way around.
The vaccine we are talking about is actually not new as in the last weeks of July, several news reports also features a Russian vaccine, that one is same as now. The vaccine was created by National Research Center for Epidemiology and Microbiology named after N.F. Gamaleya and it is based on technology that is far different from the foundations of all other vaccines against COVID-19 that is being developed today. The vaccine registration is also true, making it the first in the world but not quite said for most media in Russia and some media outlets.
The first question that all of us went through probably until this time which never said by our media.
"How come this vaccine is registered when its trials are not yet complete?"
There's a little misunderstanding that was never reported on the process of developing vaccines in Russia. By all means, in Russia, it is impossible for a wide third phase of the clinical trials for a new vaccine without the registration of the vaccine from their Ministry of Health. We can assume that if they follow the legal process like most countries do, it will fall under legal problems. The registration is only granted after the first and second clinical trial phases.
This means "SPUTNIK-V" is only temporarily registered until January 2021 for the purpose of conducting its third phase clinical trials. In addition, several reports by the media as well are publicized that the vaccine was "be the first" for COVID-19 but its recent registration is only a temporary registration for Russia to carry out properly the third phase of the trials. Those stories we've read or shared about this vaccine is simply a clear significance that some lacked on knowing their protocols.
The registration of the vaccine is under the condition that most of us questioned in accordance with Government Decree No. 441 on medicines used "In connection with emergencies, as well as for the prevention and treatment of dangerous diseases."
What's more important now is that the developers of Sputnik-V are so confident to consider to distribute the vaccine to many people from risk groups as possible. In addition, UAE, Saudi Arabia, Philippines, Brazil and other countries have already expressed their desire to participate in the third phase of clinical trials of Sputnik-V.
• THE QUESTIONS
To end this article, here I listed some questions that needed to be answered at least for us to be informed.
1. There is a lack of evidence, only three (1 ongoing) papers are published in their official website.
As I always pointing out even then, transparency is the foundation of science at the moment. Most people know almost nothing about this vaccine but this does not mean that it is bad in itself as said there's a tiny bit of data. We collect information literally bit by bit, and even on the official website of the vaccine there is very little of it. The hype is huge, including in the international media.
2. Extremely fast registration
As mentioned above the registration is temporary. Under the Russian law, without this temporary registration, it is impossible to obtain admission to larger-scale research. In the study that served as the basis for registration of the drug, only 38 healthy volunteers took part.
The number is generally ok for the first phase of the study. But the first phase should be followed by the second with the participation of hundreds of people, and the second to third, with the participation of thousands. Therefore, it is too early to draw any conclusions.
The FDA recommends, for example, that at least 3,000 participants be included in the study to adequately assess the results. Only on such a sample can it be understood that the vaccine is really safe and effective.
In the registration certificate of the vaccine there is a phrase that "post-marketing studies" are coming, which are needed "to assess the ratio of the expected benefit to the possible risk of using the drug." Taking into account the peculiarities of Russian legislation, this is the equivalent of a phase III clinical trial (although in most countries "post-registration studies" is a phase IV).
3. Security
Here's where most people are concerned especially in Phililpines and normally, it is specified during the II-III phases of research, what we mean by "post-registration research".
The frequency of adverse events was assessed, there is no open data on side effects, and a quote from the instructions, "It is not possible to more accurately determine the incidence of adverse events due to the limited sample of study participants." There are no data on delayed adverse events. There are no data on the safety of the vaccine in special populations (elderly, with comorbidities). According to the instructions, in the presence of concomitant pathology (described extremely vaguely), we can use the vaccine "with caution", which translated into the language of a practicing doctor means "probably better not" if I understand that very well.
4. Efficiency
There is simply no data on epidemiological effectiveness. We have information that the subjects develop antibodies to the S protein of the coronavirus or specific T-lymphocytes. From researching with other vector vaccines, it can be assumed that immunity can persist for up to 2 years, but this is only an extrapolation that needs to be verified.
We do not know a huge amount of details of the study and we do not have any epidemiological data at all that the vaccine will be effective "in the fields" - in a real encounter with the coronavirus.
Ideally, even in such harsh conditions as now, the effectiveness of the vaccine should be tested in randomized, double-blind, placebo-controlled clinical trials (the same opinion is shared by foreign regulators).
I sincerely hope that the vaccine will still be brought to mind without human casualties especially we have bad memories, that's something we can't just erased from their mind the concern on its safety.
References and Sources:
[1] An Open Study of the Safety, Tolerability and Immunogenicity of "Gam-COVID-Vac Lyo" Vaccine Against COVID-19 - Full Text View. (n.d.). Retrieved August 21, 2020, from https://clinicaltrials.gov/ct2/show/NCT04437875?term=Gamaleya
[2] Russian Health Ministry Registration Certificate (n.d.). Retrieved from https://grls.rosminzdrav.ru/Grls_View_v2.aspx?routingGuid=d494c688-0bc6-4c30-9e81-23f043ceb43e&t=
[3] Medicines for the treatment of infected COVID-19 will be registered under the accelerated program (n.d) Retrieved from http://www.garant.ru/news/1361745/
[4] Kate Kelland (11 August 2020). "Scientists ask: Without trial data, how can we trust Russia's COVID vaccine?
[5] Callaway, Ewen (11 August 2020). "Russia's fast-track coronavirus vaccine draws outrage over safety". Nature. doi:10.1038/d41586-020-02386-2