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The pharmaceutical companies Pfizer and BioNTech became, this Wednesday (18), the first to announce the completion of phase 3 tests of a Covid-19 vaccine. Although the results of the BNT162b2 trials have not yet been published in a scientific journal, they were considered encouraging. But companies must face a challenge: avoid the need to keep the vaccine below -70 ° C during transport, so that the immunizer does not lose its effectiveness.
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In a note, Pfizer says it has already outlined strategies to get around the problem.
“The company has developed a detailed logistics plan with tools to support the transportation, storage and continuous monitoring of the temperature of the potential vaccine against Covid-19 in an effective way. a special packing (boxed) with controlled temperature, easy to transport and handle, which uses dry ice to maintain storage conditions recommended (…) up to 15 days, ”said the company.
The microbiologist and researcher at the Institute of Biomedical Sciences of the University of São Paulo (USP), Natalia Pasternak, explains that the BNT162b2 could become the world’s first large-scale vaccine produced using RNA, a method that uses part of the genetic material of the virus to stimulate the body to produce a defense against Sars-Cov-2. However, the technique requires special care during storage.
“RNA is an easy molecule to synthesize, working with it is relatively cheap, it has many other advantages. But there is only one problem: RNA is a molecule that is easily degraded and, therefore, requires more storage care “- Natalia Pasternak
Storage and transportation
The epidemiologist from the USP School of Medicine, Paulo Lotufo, explains that most of the vaccines that we are used to taking are stored between 2º C and 8º C.
“The vaccine that came closest to a polar storage temperature was chickenpox, a chickenpox vaccine, which should be stored at -20 ° C. We have a freezer to maintain that temperature, but it is still not easy to store. Imagine carrying a vaccine that needs to be at -70 ° C ”, compares Lotufo.
“As long as Pfizer does not solve this storage problem, it is impossible for you to transport a vaccine around the world that must be kept at -70 ° C, I prefer to be cautious with the application of the vaccine” – Paulo Lotufo, epidemiologist at the Faculty of Doctor in USP
“Adapting vaccine storage cold chains to -70 ° C is something that even developed countries cannot easily do, it is not trivial,” says Pasternak.
Therefore, the microbiologist says that once the Phase 3 tests are completed, the next step should be to adapt the resistance of the vaccine to storage at higher temperatures.
“It is not easy to make this adaptation, but Moderna, which is also developing an RNA vaccine, has already managed to store it at -20 ° C and keep it in the refrigerator for up to a month,” he says.
The American pharmaceutical company Modern announced on Monday (16) that its candidate for the vaccine against Covid-19, mRNA-1273, is 94.5% effective in preventing the disease. However, Moderna has not yet completed phase 3 testing.
Next steps for BNT162b2
There are at least two steps that the vaccine must still take to reach the population:
- Scientific community review: the The data published this Wednesday by Pfizer on the phase 3 tests have not been subjected to review by the scientific community, criteria for a vaccine to enter the registration application before health regulatory agencies.
- Registration by regulatory agencies: vaccines can be marketed and available only after health regulatory agencies have analyzed all the research data and, at the end of the process, have granted registration. In the case of Brazil, for example, the agency responsible for analysis and registration is the National Agency for Sanitary Surveillance (Anvisa).
Pfizer noted that all the safety data required by the US health agency, the Food and Drug Administration (FDA), for the Emergency Use Authorization has been achieved. With that, the pharmacist informed that he intends to request the emergency use of his vaccine “in a few days”, but without giving a specific date.
However, even with emergency use, the vaccine will need to go through the FDA registration validation process.
