The front of the Laboratories of Moderna Cambridge, Massachusetts
The modern pharmaceutical company renewed its hopes in the efforts against COVID-19 this Monday, announcing that its vaccine against the disease showed an efficacy of 94.5 percent. The figure follows from the preliminary information from your phase 3 studies, the stage prior to requesting the emergency approval of the health authorities to be able to start distributing the inoculant.
The report was published after 95 infections were detected among the volunteers participating in the trials, the vast majority of which belong to the group that received a placebo: only five of those infected had received the real formula.
The announcement, which generated an uproar that resulted in the general rise of stock markets globally, came a few days after Pfizer reported that its own vaccine is 90 percent effective. The health authorities had advanced that a threshold above 50 percent would already be encouraging news, and both anticipated that they will request emergency approval in the United States in the coming weeks.
In this context, The New York Times prepared a guide that details the main characteristics of Moderna’s vaccine and the implications it has for dealing with the pandemic in the short and long term.
What did the scientists discover?
Essay randomly assigned the actual vaccine to one group of volunteers and a placebo to another. The process is “blind”, which means that neither the volunteers nor those conducting the study know the group to which each person belongs.
Over time, some volunteers contracted COVID-19. The group of experts determined that the threshold needed to obtain preliminary data on the effectiveness of the vaccine was 95 people. Once crossed, the information revealed that 90 of those people had received a placebo, while only 5 had the inoculant in their veins. Based on this, they were able to determine the encouraging figure of 94.5 percent effectiveness.
Does this mean that the pandemic is over?
In the short term, no. Regulatory authorities – and the administration of President Donald Trump – have anticipated that the first vaccines will only be available to the mass public in the United States starting in the spring of 2021. That is, in late March or early April. It was also confirmed by the main epidemiologist of the US government, Anthony Fauci. And the wait will be greater in countries where production starts later, or those that have to import it..
However, once this scenario takes place and an increasing percentage of the population is inoculated, the impact of the pandemic will begin to diminish and containment measures will become more and more relaxed.
Illustrative file photo of vials with a COVID-19 vaccine label next to the Moderna logo (REUTERS / Dado Ruvic)
What happened to the people who got vaccinated and still got sick?
The effects of COVID-19 cover a wide spectrum. A large number of people developed the disease without reporting any symptoms, while others spent weeks in intensive care, and more than 1.33 million have died as a result of it globally.
Moderna reported that, of the 95 people who contracted the disease in the study, 11 experienced severe symptoms. However, none of them had been vaccinated, which implies that the 5 who tested positive despite having been in the group that received the real inoculant showed mild symptoms. This suggests that the vaccine not only prevents people from contracting the disease in most cases, but that in those where that does not happen, the consequences they have an extremely low probability of being fatal.
Who participated in the trials?
30,000 volunteers participated in the third and final phase of Moderna’s trial. All of them are in the United States, unlike what has happened with other pharmaceutical companies, which distributed their tests throughout different countries and continents.
A quarter of the volunteers are 65 years or older. That is, they belong to the main risk group. 63 percent of them are Caucasian, 20 Latino, 10 African American, and 4 Asian American. Of the 95 people who contracted the disease, 15 are 65 or older.
This group also included 12 Latinos and 4 African Americans, two of the ethnic demographics most affected by the pandemic. Efficacy appeared to be the same across subgroups, Moderna reported. However, scientists should wait to have all the information before confirming this assertion.
Did Moderna receive funding from the United States?
Yes, the government invested nearly $ 1 billion in vaccine development. In mid-April, the company received USD 483 from the authority for advanced biomedical research and development (BARDA) and, based on the progress made, it was awarded another USD 472 million in July.
The investment took place within the framework of the operation “Maximum Speed” (Warp Speed, in English), which seeks to produce and distribute 300 million doses of vaccines in the country, the first of them in January 2021. Consequently, the pharmaceutical company anticipated that all the approximately 20 million doses that it could produce before the end of the year will be used in the North American country.
The Donald Trump administration also announced in August that it had bought a total of 100 million doses of the vaccine for a sum of USD 1,500 million, to be confirmed if it is actually approved. The contract also includes an option for an additional 400 million doses, according to statements from the company and the US Department of Health.
The chief epidemiologist in the US government, Anthony Fauci. Photo: POOL VIA CNP / ZUMA PRESS
How do the results compare to those of Pfizer?
Pfizer scientists released less information than Moderna. In their announcement, they indicated that 94 volunteers had contracted the disease and that from this they concluded that the effectiveness was 90 percent. They did not state how many people had received the placebo, although the information is expected to become public in the near future.
However, both are quite similar and far exceed the threshold of effectiveness determined by the US regulatory agency.
One difference between the two is the temperature required to store the ampoules. Given the instability of the RNA – the type of vaccine from Pfizer and Moderna – there is a temperature limit beyond which the vaccine degrades. The first one does it in temperatures higher than -70 ° C. The Moderna, meanwhile, needs storage and transport at -20ºC. But their doses can last longer in a refrigerator than initially thought – up to 30 days – which would greatly facilitate distribution logistics..
And the other candidates?
The Pfizer and Moderna vaccines not only use the messenger RNA method, but also focus on in producing the spike protein. Other candidates do not use RNA but do have the aforementioned protein in the center. The success of both augurs that these others could have it too.
Other pharmaceutical companies have created vaccines from an adenovirus. For example, Russian Sputnik V vaccine uses human adenovirus technology from two different vectors, Ad5 and Ad26, for a first and a second injection. However, Sputnik V does not contain live human adenoviruses, but human adenoviral vectors that are not capable of multiplying and are completely safe for health.
In recent days it was known that the Sputnik V vaccine reached 92% effectiveness in the first Phase III trials and that “there were no unexpected adverse events during the trials.” AstraZeneca and Johnson & Johnson are also testing their vaccines based on this methodology..
How long will the effectiveness of the vaccines last?
It is still not clear. Both Moderna and Pfizer began their trials on July 27, so they have only followed volunteers for a limited number of months. They could provide long-term protection or thin out over time and require reinforcement.
What is the next step?
Both pharmaceutical companies continue to collect information from the trials. They plan to apply for emergency approval from the US regulatory body (FDA) when they do. At that time, the government agency will evaluate the requests and consult with an outside expert committee before making a decision.. Then the Centers for Disease Control (CDC) will issue recommendations on who should be vaccinated first.
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