(CNN Español) – The emergence of variants of the coronavirus is changing the way the disease is fought.
In this episode, Dr. Elmer Huerta talks about the recommendations that the United States Food and Drug Administration released to adapt tests, treatments and vaccines to be effective against the detected variants of covid-19.
You can listen to this episode on Spotify or your favorite podcast platform or read the transcript below.
Hello i’m doctor elmer Huerta And this is your daily dose of information on the new coronavirus. Information that we hope will be useful to take care of your health and that of your family.
Today we will see what are the latest recommendations made by the United States Food and Drug Administration, the FDA, so that the development of vaccines, diagnostic tests and treatments are adapted to the new variants of SARS-CoV-2, the covid virus -19.
Coronavirus variants: a concern in the scientific community
As we have heard in several episodes, there is a lot of concern in the scientific community about the appearance of variants of the new coronavirus.
More specifically, we are talking about three of the identified variants of importance in public health:
- B.1.1.7, discovered in the UK;
- The B.1.351, discovered in South Africa,
- And P.1, discovered in Brazil.
Preliminary studies suggest that some variants are more contagious than the original discovered in Wuhan, China.
The variants identified in South Africa and Brazil have the property of being resistant to the neutralizing activity of antibodies directed against the original variant.
That fact has two possible profound implications:
- It is possible that a person who already suffered from COVID-19 with the original variant could be reinfected with the resistant variants.
- Vaccines, diagnostic tests, and monoclonal antibody treatments lose their effectiveness against the new variants. That possibility has already been demonstrated with several first-generation vaccines.
This is why the FDA, in a February 22 statement, calls the attention of pharmaceutical laboratories to adapt products such as vaccines, diagnostic tests and treatments with monoclonal antibodies to the new variants.
What the FDA Says About Vaccines and Coronavirus Variants
Regarding vaccines, the FDA recommended that for now – and with charge to discuss the details in the future – the new vaccines do not have to go through the lengthy phase 1, 2 and 3 studies, but rather demonstrate that they have the ability to stimulate the defense system in studies in hundreds of people who have not been previously vaccinated, as well as to study the effect of new vaccines as booster doses in previously vaccinated people.
Obviously, the advantage of these studies is that they would be smaller, take less time than large-scale clinical trials, and could be conducted in a single age group, with the results then being extrapolated to other age groups.
FDA officials confirmed that the new strategy for the new COVID-19 vaccines builds on the experience that already exists with the annual development of seasonal flu vaccines.
According to FDA Acting Commissioner Dr. Janet Woodcock, science already has experience with the fact that, like what is happening with the new coronavirus, viruses change over time and seasonal flu changes with time. very often.
Molecular tests and variants
Regarding the molecular tests used to identify the virus in patient secretions, the FDA said it has already identified some tests that are not accurate enough to diagnose new variants of this coronavirus.
This means that, despite having the virus in the respiratory tract, the test says that the virus is not present, that is, it is a false negative result.
The FDA guidance provides recommendations for laboratories developing the tests to keep an eye out for future genetic mutations of the virus and can easily adapt to the development of new tests.
What about antibody treatments?
Finally, and in relation to treatments with monoclonal antibodies, the FDA recommends that the laboratories that produce them modify the selection of their antibodies so that they adapt to the new variants.
Monoclonal antibodies, as we described in the November 12 and February 7 episodes, are concentrates of antibodies or immunoglobulins of a single type that are specifically directed against the new coronavirus.
In summary, this issue of the emergence of variants of SARS-CoV-2 is not a trivial matter and, as has been described, it will radically change the development of vaccines, diagnostic tests and treatments against Covid-19.
We are sure that science will know how to adapt to changes.
In the meantime, regardless of the variant that may be circulating in your community, we advise you to:
- Avoid infection by using double mask,
- Avoid crowds of people,
- Do not organize or attend social gatherings with people who do not live in your home,
- And maintain hand and surface hygiene.
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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If you have any questions you can send it to doctor Elmer Huerta via Twitter. You can also head over to CNNE.com/coronaviruspodcast for all episodes of our “Coronavirus: Reality vs. Reality” podcast. fiction”.