What vaccines are already licensed?
- Russian vaccine "Sputnik V"
The world's first vaccine against
the drug will be produced at two sites inthe country - in the center of Gamaleya and at the pharmaceutical plant "Binnopharm". Doctors and teachers will be the first to receive the finished vaccine. The drug was developed by the Gamaleya National Research Center for Epidemiology and Microbiology of the Russian Ministry of Health.
The vaccine is made on the basis of humanadenovirus, which acts as a vector, that is, the carrier of the genetic information of the SARS-CoV-2 coronavirus. Based on this information, the cells of the vaccinated produce an S-protein (aka spike) - it triggers an immune response, in particular, the formation of antibodies and activation of T cells.
Another feature:Sputnik V is available in two forms - frozen and dried. The dried form simplifies logistics, but formally it is another drug that requires separate research and registration.
The results of preclinical trials are still notpublished, although the head of the development group promised to do so soon back in mid-July. Phase I / II test results are published in The Lancet. The volunteers (a total of 76 people) developed antibodies, including neutralizing antibodies. There were almost no people over 30 in the groups. The results of efficacy trials (that is, phase III trials) in the scientific press promise to be published at the end of the study.
November 24 RDIF, sponsor of the vaccine developer,published a press release with the results of the second interim analysis of the Phase III results. By this time, 18793 volunteers had been vaccinated, of whom 14095 received the vaccine, and 4699 received a placebo. By the time of the second interim analysis, 39 people fell ill, of which only 8 were among those who received the real vaccine.
Based on these data, the authors conclude thatvaccine efficacy of 91.4% (the first interim analysis conducted on November 11 reported about the same efficacy). In addition, the developers say that preliminary data on volunteers on the 42nd day after the first injection (that is, if you look only at those who were vaccinated earlier than others and have already reached the 42nd day) show the vaccine effectiveness above 95%. Neither the number of cases in this subgroup, nor other details about them are given.
We do not know the details of the preclinicalstudies on animals, a protocol with the details (and criteria for success) of the study has not been published, and the results of an expert review, on the basis of which the vaccine was registered in Russia, have not been published. Federal Law FZ-61 requires the Ministry of Health to publish expert opinions on the basis of which the drug enters the market, but this requirement has not yet been fulfilled. Most Western vaccine manufacturers have voluntarily published their detailed research protocols.
Today, on December 2, it became known that Vladimir Putin ordered from December 7 to start a free mass vaccination against coronavirus - Sputnik V will be vaccinated. Vaccination will be voluntary.
- Russian "EpiVacCorona"
The vaccine consists of three synthetic SARS-CoV-2 peptides, combined with a carrier protein and attached to an auxiliary substance (adjuvant) - aluminum hydroxide.
The only peptide-based vaccinepassed beyond the first phase of clinical trials and even received registration (even before the start of efficacy trials). Like any peptide vaccine, it contains only very small fragments of viral proteins, which means that it is most susceptible to variability on the part of the virus, which can adversely affect its effectiveness.
The release of the first commercial batches of the vaccine beganin October 2020 at the licensed own production sites of "Vector". The vaccine will be effective against the virus even after mutations. This is due to the use in its composition of antigens obtained from the genetic code of COVID-19, which are practically not subject to change.
EpiVacKoronu can be stored in a regularrefrigerator at a temperature of 2 to 8 degrees. The developers claim that it retains its properties for up to two years. The vaccine is given twice with an interval of 21 days, then after 6-10 months, after which the revaccination should be carried out every three years. In the instructions, of the side effects, only pain at the injection site (observed in 10% of subjects) and a short-term increase in body temperature not higher than 38.5 ° C were mentioned.
At the moment, 35 thousand units have been produced.doses, a total of 50 thousand doses are planned to be produced by the end of 2020. The vaccine should go into civilian circulation on December 10, and mass vaccination will theoretically begin in 2021. For citizens of the Russian Federation, the vaccine will be free. Vaccination will be done on a purely voluntary basis.
The first to be vaccinated are medical workersorganizations (all employees), educational organizations, police, public transport, trade, social protection bodies, catering establishments, hotels, hairdressers, dry cleaners, banks, security companies.
Preclinical test results are unknown.all available details are limited to the instructions for the drug and information on the Rospotrebnadzor website. The results of the Phase I / II trials are also not published (it is only reported that 14 and 86 people took part in them, respectively, and “the induction of specific antibodies occurred in 100% of the volunteers”), efficacy trials (post-registration) have just begun.
According to the latest news, while producedonly the first lots of vaccine for efficacy trials. On November 20, Vector told Interfax that 15 thousand doses of the vaccine had been produced, by the end of 2020 it is planned to produce a total of 50 thousand doses, and mass production is planned for 2021.
- British Pfizer / BioNTech
A vaccine based on artificially synthesizedmessenger RNA, packed in lipid vesicles - penetrating into the cell, nucleic acid, like the RNA of a real virus, stimulates the production of S-protein. BioNTech initially tested two versions of the vaccine, BNT162b1 and BNT162b2, and it was the second that was found to be more successful due to the lower frequency of side effects. In it, as in most adenovirus vaccines, the usual natural version of the S-protein is present, with only small point changes.
MRNA vaccines are being tested for the first timepeople, until now this technology has only been developed. RNA itself is quite unstable, lipid bubbles, apparently, too - all this is reflected in the fact that this vaccine needs to be stored in deep freeze conditions, at minus 70 degrees Celsius (this temperature is achievable in special refrigerators and when using dry ice). In a recent press release, the companies said they are trying to solve this problem by creating special refrigerators with mobile tracking, which will require "recharging" with dry ice just once every 15 days.
According to the company, the vaccine is administered in two stages and gives protection against coronavirus 28 days after ingestion. One injection is not enough for the successful formation of immunity.
There is an opinion that insufficientthe amount of information about the vaccine. In particular, we are talking about possible side effects. However, no comprehensive analysis has been published at this time, including on Pfizer. Problems may arise already at the stage of transportation of containers with a vaccine. The fact is that BNT162b2 must be stored at a temperature not exceeding -70 degrees Celsius. If you have thawed the vaccine, then you must use it for a maximum of five days.
For transportation, storage and defrostingvaccines will need expensive infrastructure. And the requirement to maintain extremely low temperatures can potentially lead to spoilage of large quantities of the product. Nearly 3 billion people around the world live where there are not enough suitable storage facilities. Somewhere their work will be interrupted by power outages. Moreover, there are not enough medical workers everywhere to administer drugs.
What vaccines are on the way?
- AstraZeneca and Oxford University vaccine
This is a vector vaccine (with the technical nameAZD1222) based on the chimpanzee adenovirus (ChAdOx1). There are two identical injections with a break of 28 days. It is the only chimpanzee adenovirus vaccine to make it to Phase III trials. The use of just such a vector could potentially make the vaccine more effective in those who are already immune to human adenoviruses. According to the manufacturer, the vaccine can be stored for up to six months at temperatures from plus 2 to plus 8 degrees.
Initially preliminary results of phase IIIwere expected only at the end of December, but despite the difficulties, they became known from the company's press release on November 23. The efficacy was 90% when the volunteers received only half the dose at the first injection. If both were given the full dose, the efficacy was only 62%. The analysis was carried out with 131 cases (there is no breakdown by cases in different groups yet - it can be expected in the promised scientific publication). It is important to note that there were no seriously ill patients in the vaccinated group, as well as no serious side effects were noticed.
- Ad5-nCoV by CanSino Biological
Chinese Human Based Vaccineadenovirus type 5, similar to the Sputnik V vaccine, but consisting of only one component. Carries the same naturally occurring S-protein variant. It is tested not only in Russia, but also in Saudi Arabia, Mexico and Pakistan. In Russia, testing and localization of production is carried out by the Petrovax company.
The vaccine has shown encouraging results instudies of the first (108 people) and second phase (508 people) studies. The volunteers developed neutralizing antibodies, however, due to the difference in measurement approaches, it is impossible to directly compare the results of the immune response to vaccines from different manufacturers. The developers themselves in the article with the results of these tests call the immune response after a single vaccination "significant".
- Vaccine Center. Chumakova
Vaccine based on inactivated SARS-CoV-2 with aluminum hydroxide as an adjuvant. It is being developed at the M.P. Chumakov Scientific Center for Research and Development of Immunobiological Preparations.
Preclinical test results, like everyone elseRussian vaccines are not published. It is only known on what animals they were carried out: on mice, marmosets, rabbits and guinea pigs. Some of the details were found out by the employees of the N + 1 website, talking with the creators of the vaccine, for example, that after the injection, "sufficient" amount of antibodies was produced. According to the developers, the first phase of clinical trials has just begun, in which 15 people should take part; the second will have 200 volunteers, 50 of them will receive a placebo (one study of this vaccine, including 300 volunteers, is registered in the Russian register of research approvals).
- Moderna / NIH vaccine
RNA vaccine (mRNA-1273), very similar to BNT162b2 from Pfizer / BioNTech. Contains genetic material of the same natural S-protein of the coronavirus, with the same small dimensions.
Based on the results of a preliminary analysis, the vaccineshowed an efficiency of 94.5%. Of the 95 study participants, 90 were in the placebo group and only 5 were in the vaccinated group. Unlike the Pfizer / BioNTech case, there was not a single serious illness in the vaccinated group.
According to the company's first results reportthe third phase of the study, 30 thousand volunteers took part in the experiment. Of these, 196 people became infected with the coronavirus - these are 185 volunteers who received a placebo, and 11 people who received the vaccine. This means that the drug prevents 94.1% of cases.
None of the 30 severe cases wereregistered in the group that received the vaccine, which confirms that the new vaccine prevents 100% of severe cases of COVID-19. During Moderna's research, one person who was in the placebo group died of coronavirus.
Major new safety notes duringno tests were found. The most common side effects are pain, redness at the injection site, fatigue, muscle or joint pain, and headache. After the second injection of the vaccine, these effects were more frequent and more significant, the company said.
Company representatives said that nowthe drug must be approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
- Johnson & Johnson
Johnson & Johnson is now in the third stage of a study of the developed drug, in which up to 60 thousand volunteers are to take part.
The company previously stopped testing in Octoberdue to the "unexplained" illness of the research participant. The case was investigated by the independent Data and Safety Monitoring Board (DSMB), as well as by the company's medical staff. However, in late October, its representatives said Johnson & Johnson was preparing to reopen the vaccine trial, as it found no evidence that it caused serious illness in one of the study volunteers.
Animal studies publishedand the results of the first tests on volunteers. The results are good, about the same as with other vector vaccines. There is no news on the efficacy studies yet - except that in October they had to be interrupted due to the volunteer's illness (which disease is not clear, as well as whether the patient was part of the placebo group). After a few days, the study continued.
What will be available for Russians?
Not all vaccines currently being tested will becomeare available in Russia immediately, even if the test results are positive. To register a new drug, you must undergo an examination of the Ministry of Health; that is, it will be necessary to conduct separate clinical trials in Russia or Russia's participation in international vaccine research.
Most likely, those available to Russians will bedrugs that are being tested in the country. These are five vaccines: "Sputnik V" Center. Gamaleya, "EpiVacCorona" center "Vector", vaccine Center named after Chumakov, a vaccine of the Chinese company CanSino Biological and a vaccine that was jointly developed by Oxford University and AstraZeneca (part of its international trials is being carried out in Russia).
This, however, does not mean that vaccines againstPfizer / BioNTech or Moderna will definitely not be available to Russians. In the spring of 2020, the government issued Order No. 441, according to which an exception to the mandatory examination rule for medicines already registered in the United States, the European Union, Canada and other states, the list of which may be established by the Ministry of Health, is allowed. Accordingly, they hypothetically can get into our pharmacies.
However, there is an almost guaranteed way to get vaccinated with the vaccine - to come to the country of origin and get it there.
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