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northIn this “cold war” for a vaccine against a respiratory disease that plagues the whole world, caused by a new virus, a third element appears, China, which it promises to disclose, still in November, the first efficacy results of a vaccine being tested in Brazil, Indonesia and Turkey. However, according to a study published Tuesday in The Lancet, the Chinese vaccine Coronavac proved to be “safe”, having induced an antibody response in 97% of the healthy volunteers tested.
Despite the “encouraging news” about possible vaccines for the COVID-19-19, the World Health Organization (who) calls for caution, as more data needs to be analyzed to accurately assess its efficacy and safety profile, without which it cannot be administered.
Here are some essential points on the subject:
What are the efficacy results of previously published experimental vaccines?
Me 9 November, a multinational American pharmaceutical company Pfizer and partner biotech German BioNTech announced that its experimental vaccine for COVID-19-19 was 90% effective, based on the analysis of 94 cases of COVID-19-19.
Two days later, the manufacturer of Russian competitor Sputnik V announced a 92% effectiveness, based on data from 20 cases.
Most recently, Monday the 16th November, the modern American biotechnology company indicated that its candidate vaccine is 94.5% effective in preventing COVID-19-19, taking into account the analysis of 95 cases.
What technologies are used in the manufacture of these vaccines?
Both Pfizer’s and Moderna’s experimental vaccines are based on genetic technology from RNA messenger, which uses the person’s body to produce a key protein from the coronavirus gives COVID-19-19, in the case of spicule, “the gateway” to the virus into cells, and stimulates the immune system to create antibodies against the virus.
Once injected, this type of vaccine instructs healthy cells to make copies of the spicule do coronavirus SARS–CoV-2, stimulating the production of antibodies neutralizers. Being after infected With the virus, the body can recognize-this combat-the.
The Russian experimental vaccine is different, it induces the creation of antibodies against coronavirus gives COVID-19-19 to two adenovirus that have been genetically modified to produce spicule do SARS–CoV-2.
How many doses are needed?
Candidate vaccines of Pfizer and Moderna are given in two doses.. Pfizer is more than three weeks old, Moderna is four weeks apart.
Both adenovirus The modified components that are part of the composition of Sputnik V, authorized in Russia before the final efficacy and safety tests begin, are injected three weeks apart.
What are the conditions of conservation and storage?
In this sense, Moderna’s experimental vaccine seems to add points to Pfizer’s. The company biotech Moderna maintains that her candidate can stay, for six months, at a -20ºC temperature, equivalent to the temperature of most household or medical freezers.
In the places where the vaccine is administered, the storage temperature can rise between 2ºC and 8ºC, and the vaccine can be kept in a refrigerator, and under these refrigeration conditions Moderna expects it to remain stable for 30 days.
A Pfizer Candidate should be stored at much lower temperatures, below 70ºC days before use, which can be a logistical obstacle for its administration.
If approved, how many vaccines could be available?
Pfizer and Moderna intend to request, still in November, authorization to the US regulator for the emergency use of its experimental vaccine against COVID-19-19, as soon as additional data attest to its efficacy and safety.
Pfizer aims to have up to 50 million doses available by the end of 2020, enough for 25 million people, and to produce up to 1.3 billion doses by 2021.
The European Union signed an agreement with the duo Pfizer-BioNTech for the purchase of 200 million doses, with the option to purchase an additional 100 million doses.
Moderna expects to produce 20 million doses by the end of 2020, the equivalent of vaccinating 10 million people. The initial batch will be destined for the United States.
What doubts remain?
the effectiveness resultsAlthough the initials were announced by the manufacturers of experimental vaccines, they have not been scientifically scrutinized.
On the other hand, more confirmed cases of COVID-19-19 out of thousands of trial participants for consolidate the efficacy and safety profile of vaccines in test. Pfizer aims the bar at 164 boxes and Moderna at 151 before proceeding with the emergency use request.
Not known how long does the protection conferred by these experimental vaccines, can prevent people (including those without symptoms) from transmitting the virus, if they only reduce the most serious forms of the disease or if they work well in groups more vulnerable to infection, such as the elderly and / or with chronic diseases.
Moderna’s candidate vaccine appears, according to the company biotech, be effective in preventing infections more serious, as there were no serious cases of COVID-19-19 among volunteers who received the vaccine, compared to 11 people who were injected with a placebo.
According to the preliminary data from Moderna, only five participants who received two doses of their experimental vaccine became ill, compared to 90 who received a placebo. The efficacy of the potential vaccine was measured two weeks after the administration of the second dose.
In the case of Pfizer’s candidate vaccine, the pharmacist did not indicate how many volunteers remained. infected after receiving the vaccine or placebo. The effectiveness of the indicated experimental vaccine, 90%, in a total of 94 cases identified with COVID-19-19, was measured one week after the volunteers received the second dose.
Not enough time has passed since inoculation to see if there are significant undesirable effects long-term. Some participants in the Moderna trial showed severe fatigue, muscle, joint and headache pain after vaccination – effects that the company said were short-lived.
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