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The Moderna company announced the COVID-19 vaccine to provide a 94.5% protective effect according to the results of the initial data analysis in the third phase clinical trial – Photo: AFP
On November 16, Stéphane Bancel, CEO of the American pharmaceutical company Moderna, announced that the COVID-19 mRNA-1273 vaccine they developed was 94.5% effective in the initial evaluation of clinical trial data. detection stage three.
Use the gold standard
The third phase of the clinical trial is the real-life test of corona virus infection prevention capabilities. Since the people taking the test cannot intentionally infect others, they must wait to see who will become infected with COVID-19 among the volunteers. The team then compared the infection rates between Moderna’s vaccinated group and the placebo group.
Unlike the vaccines released last week by Pfizer and BioNTech, Moderna provides more information on COVID-19 vaccine test subjects, demonstrating that its efficacy works across many ages and ethnic groups. different.
According to observers, although it is only an initial assessment, the results of Moderna’s research on the COVID-19 vaccine are still considered important, bringing many exciting hopes. Because in this trial, neither the drug company nor the volunteers knew who got the vaccine and who got a placebo.
This is called the “gold standard” in clinical trials and is intended to prevent both groups from changing behavior or engaging in actions that could intentionally alter research results.
There will be a group of independent government-appointed scientists under the Data Security Oversight Board (DSMB) who will act as a go-between between volunteers and vaccine testers. Only the DSMB knows who gets the vaccine and who doesn’t, but it does not provide this information to the pharmacy. They are also the team that monitors the test to make sure there are no serious complications and to stop immediately if something goes wrong.
Safety is paramount
Moderna’s announcement on November 16 also means that the world will almost certainly have more than one highly effective COVID-19 vaccine, and the prospect of ending the pandemic is no longer blurred.
However, there are still some topics that Vox magazine (USA) mentioned with caution. First, the results published by Moderna on the efficacy of the mRNA-1273 vaccine are only preliminary results. The vaccine should be given in two doses 4 weeks apart and some side effects have been reported in the trial, albeit mild to moderate in severity, with no serious side effects.
However, since vaccines are something that will have to be used by millions, or possibly billions of people, even minor side effects will show up more often when given to many people, so it is definitely a matter of necessity. they continue to be monitored. In fact, candidates for the Johnson & Johnson COVID-19 vaccine or the Oxford University vaccine and AstraZeneca also had to suspend testing due to complications observed in the volunteers.
In addition, the third phase of the clinical trial is not over yet and the results of Moderna’s initial evaluation, such as the Pfizer and BioNTech vaccines, are only presented in the press release, not in a report. science is peer-reviewed, an important professional evaluation criterion. Moderna has not yet responded to these issues.
Furthermore, while proving the efficacy of vaccines is important, the roadmap for millions of people to be vaccinated in the near future also poses many challenges in logistics (storage, preservation and logistics). went ahead …). Both vaccines must be refrigerated or at a low temperature.
According to Vox magazine, Pfizer / BioNTech vaccines should be stored at -70 degrees C or below, while Moderna’s vaccine works stably when stored between 36 and 46 degrees Fahrenheit (2.2 – 7.7 degrees C) for 30 days.
MRNA technology vaccine solution
Moderna’s vaccine is the second mRNA vaccine to date, after Pfizer and BioNTech vaccines, which have been shown to be highly effective against the corona virus. It is a new technology that uses the genetic material RNA, in this case mRNA, to make a vaccine.
This technology is a major departure from traditional vaccine manufacturing technology (which often uses weakened viruses, killed viruses, or part of viruses). With RNA and vaccines developed using the same DNA technology, no viral structures are injected into the body.
When the competitive advantage resides in … the refrigerator
After nearly 10 months of racing to develop effective vaccines, humanity has a headache over how to transport and distribute vaccines. All the effort and money spent by pharmaceutical companies now depends almost entirely on … refrigerators (equipment for storing vaccines during transportation).
Pfizer’s super cold freezer stores vaccines at the Puurs facility (Belgium) – Photo: REUTERS
The Pfizer vaccine comes and goes
On September 11, the pharmaceutical company Pfizer (USA) and its partner BioNTech (Germany) announced that they owned the world’s first COVID-19 vaccine with a trial efficacy of 90%. This information immediately created a green wave in all equity markets. But the fun is not long, people worry again because this vaccine requires freezing at -70 degrees C during transport.
After collecting more data, Pfizer determined that the vaccine could stay between 2 and 8 degrees Celsius for 5 days, but for longer storage, the vaccine should be stored at extremely cold temperatures of around … 70 degrees Celsius – that means that many people in remote areas will probably not get this good vaccine.
Dr. Kelly Moore of the Immunization Action Coalition and an advisor to Pfizer admits that “there has been no vaccine in the United States that requires such a storage temperature prior to use.”
Even in the US or around the world, there aren’t many super cold freezers available, said Prashant Yadav, a specialist in the healthcare supply chain. The only places with super cold storage lines are academic medical centers, relatively large hospital systems …
According to Yadav, the only way to distribute Pfizer vaccines is to ship them almost daily or at least several times a week from the production site to the vaccination sites to ensure that they are effective.
Easy to keep, will you win?
On November 16, another American pharmaceutical company, Moderna, eased concerns about storage temperature when it stated that its COVID-19 vaccine is 94.5% effective and does not need to be kept at a higher temperature. cold like the Pfizer vaccine. A Moderna spokesperson emphasized that its vaccine should only be stored at temperatures close to home refrigerators.
“Our vaccine can be stored refrigerated at 2-8 degrees C for about a week,” he confidently stated. Britain immediately “closed” 5 million doses with Moderna, scheduled for delivery before spring 2021. A European Union official also revealed to the Reuters news agency that it is in the process of negotiating to buy “millions” of dose. Moderna’s vaccine costs $ 25 per dose.
So we can see that although Pfizer went ahead, but later Modern. The Pfizer and Moderna vaccines, developed on the basis of mRNA technology for the first time, promise to turn the human body into a factory to produce the COVID-19 vaccine itself.
If the efficacy of the vaccine was not taken into account as a preliminary result, the fact that the Pfizer vaccine had to be kept at the same temperature as the Antarctic winter during transport caused the vaccine to lose its competitive advantage. before the opponent.
BAO DUY – REGISTER
Mr. KIM THOUA
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