SEOUL, July 30 – The modern biotech company, in collaboration with the United States Government, started one of the world’s largest trials on Monday to test the effectiveness of an experimental vaccine against COVID-19 on 30,000 volunteers, who will be recruited into 89 places in the country.
It is the first experimental vaccine outside of China to reach this critical point to verify its efficacy and safety before distribution.
In a call to the press, the main epidemiologist in the US, Anthony Fauci, explained that the first injection of Moderna’s experimental vaccine was administered to a volunteer in Savannah (Georgia) at 06.45 in the morning today (12.45 GMT).
In this way, the Moderna vaccine entered its phase 3, intended to test the drug in a large sample of the population. Modern, based in Massachusetts, is the first American company to have reached that level in its research and the second in the world behind the Chinese firm Sinopharm.
Specifically, the Sinopharm-affiliated Wuhan Institute for Biological Products and the Chinese Academy of Sciences began testing their vaccine on 15,000 volunteers in July with the support of the United Arab Emirates.
HALF WILL RECEIVE A PLACEBO
In the US, Moderna’s vaccine will be tested on 30,000 volunteers, who will receive two doses 28 days apart. Of all the participants, half will receive an injection of a placebo in order to make a statistical evaluation of the vaccine’s effectiveness, Fauci detailed.
Neither the volunteers nor the doctors administering the vaccine will have information on who receives the placebo and who receives the vaccine.
“It is a world record for us to have been able to go from sequencing (of the SARS-CoV-2 virus) to phase 3 of a vaccine in such a short time. It has never been done before, ”explained Fauci, who assured that this process, which has only taken about 6 months, has not compromised the scientific rigor or the safety of the trials.
Once the volunteers are vaccinated, the experts will analyze possible side effects and the effectiveness of the vaccine, especially if it can prevent the most severe cases of COVID-19 and how many doses are necessary to ensure an immune response.
One of the challenges that researchers face is getting enough volunteers in the areas of the country and in the population segments most affected by the pandemic to be able to have a representative sample of the population, Fauci detailed.
OTHER THREE EXPERIMENTAL VACCINES
At the same press conference, the director of the National Institutes of Health (NIH), Francis Collins, explained that three other companies (Johnson & Johnson, Novavax and AstraZeneca) will soon begin phase 3 of their trials and will each need 30,000 volunteers. .
All of them are part of the “Warp Speed” operation launched by the US government to promote the development and ensure treatments and vaccines against the COVID-19 pandemic in 2021.
A fourth vaccine, developed by Pfizer and BioNTech, is expected to begin phase 3 this month, although it is not part of that federal program, Collins said.
THE ELECTORAL COMPONENT OF THE VACCINE
Meanwhile, Fauci explained that the conclusions on the effectiveness of Moderna’s experimental vaccine could come “at the beginning of November, but it could be earlier”, which means that the results could be known before the elections of November 3, in which President Donald Trump seeks reelection.
The dates of presentation of these results are essential, since if they occur in October they could fully enter the final stretch of the campaign for the November elections and give the president arguments in favor of his reelection.
In fact, Trump on Monday tried to highlight one of the few topics that invite optimism in the US in the midst of the pandemic: the rapid development of a vaccine.
To that end, the president visited a research center in North Carolina on Monday where the components for the Novavax experimental vaccine are being produced.
Speaking to the press, Trump assured that it is the first time that the United States has undertaken such an important effort of innovation since the Second World War and assured that his goal is that, once a vaccine is approved, the Americans can access immediately to her.
“I want the vaccine to be available to Americans. And I suppose we will have many others for the rest of the world. The rest of the world is suffering a lot from this virus from China, ”said the president, who blames Beijing for having caused the virus, something the Chinese government denies and in return blames Washington.
North Carolina, the state Trump went to, is key to the November election.
In some electoral polls, the president has appeared up to two digits below former Vice President Joe Biden, a virtual Democratic presidential candidate.
The US is the country hardest hit by the pandemic in absolute terms with 4.2 million cases and more than 147,000 deaths, according to an independent count by Johns Hopkins University.