Moderna faces key problem in 1:37 vaccine trials
(CNN Spanish) -
Many await the arrival of the coronavirus vaccine.
In countries like the United States, its approval has been politicized, and the president herself, Donald Trump, assured that it would be ready before the presidential elections in November.
However, Moderna, who makes the vaccine with the National Institute of Infectious Diseases and Allergies of the United States, said that the vaccines will not be ready until the first quarter of 2021.
You can listen to this episode on Apple Podcasts, Spotify, or your favorite podcast platform, or read the transcript below.
Hello, I am Dr. Elmer Huerta and this is your daily dose of information on covid-19, information that we hope will be useful to take care of your health and that of your family.
Today we will see when the first vaccines for the coronavirus could be ready.
In recent and surprising statements to The Financial Times newspaper, Stéphane Bancel, CEO of Moderna company - whose coronavirus vaccine is in phase 3 - said that his company will apply for a license for the emergency use of the vaccine at the end of November , adding that it would not be ready until 2021.
Without a doubt, that surprising statement gives us a glimpse of what the development of vaccines can be.
And also when they could have them available to the general public.
Moderna's coronavirus vaccine would be ready in 2021
As we mentioned in the July 16 episode, one of the most promising coronavirus vaccines is the one developed by the US National Institute of Infectious Diseases and Allergies in partnership with the Modern Laboratory in Massachusetts.
The vaccine, which uses a new technology based on a segment of genetic information from the new coronavirus, is already in phase 3 of a clinical study.
It is the final phase, destined to know if the vaccine is effective and safe.
On a personal note, as we recounted in the episodes of August 19 and 20, that is the vaccine in which I am participating in the study and of which I have already received two injections, not knowing if it was placebo or the real vaccine.
Let's go back to Mr. Bancel's statements.
He said his lab's coronavirus vaccine won't be ready until the northern spring of next year.
That is, for April, May or June 2021.
These statements represent a strong blow to all the people who were hoping that the vaccine will be ready by the end of this year.
And that includes the president of the United States, Donald Trump.
The politicization of the vaccine
In a recent debate with Joe Biden, he asked why he was contradicting the directors of the CDC and the White House Vaccine Task Force, who said vaccines would be ready as soon as next year.
Trump responded that he had spoken with executives from several pharmaceutical companies - including Moderna.
He said he had been assured that the vaccines were highly likely to be ready before the November 3 election.
It is very important to remember, as we said in the September 10 episode, that all vaccine trials have an independent group of researchers called a "data and safety monitoring board."
Who controls the quality of the coronavirus vaccine?
That board is constantly monitoring the data to determine the level of efficacy and the side effects that the vaccine or placebo could produce.
And it is ultimately the one that decides whether studies should continue or should be suspended.
It does this based on evidence from efficacy data or side reactions.
There's no doubt that when Bancel says Moderna's vaccine won't be ready until next year, it's not their decision.
It is the decision of the data and safety monitoring board which, in this case, respects an agreement signed with the Food and Drug Administration, the FDA.
In this agreement, he undertakes not to request an emergency license until two months after having vaccinated at least half of the volunteers.
In this regard, this September 25, the 15,000th volunteer was injected with the second dose.
As we said, this board acts as a true safety valve so that vaccines are not approved prematurely, and its independent nature allows confidence in its decisions.
When will the vaccine be ready?
It is not known what will happen to the other eleven vaccines that are currently in phase 3. But if what happened with the Moderna laboratory is a sample, it is likely -as many experts had said- that the coronavirus vaccines will not are ready until the first half of 2021.
What would make the manufacture, storage and distribution of the vaccines be done then in the second half of 2021, and the general distribution during the year 2022.
It is possible that the only vaccine that can request it earlier is the one from the Pfizer laboratory, because - according to Mr. Bancel - its researchers have designed a different type of study and it has a shorter interval between doses.
In the coming weeks we will have news about the development of the other vaccines that are in phase 3, hoping that - as Moderna has done - science will be used as the main guide in making decisions.
Do you have questions about the coronavirus?
Send me your questions on Twitter, we will try to answer them in our next episodes.
You can find me at @DrHuerta.
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Thanks for your attention.
If you have any questions you can send them to Dr. Elmer Huerta via Twitter. You can also head over to CNNE.com/coronaviruspodcast for all episodes of our “Coronavirus: Reality vs. Reality” podcast. fiction".
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