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Pfizer vaccine against covid-19: what is the next step?

2020-11-10T01:26:54.686Z


Pfizer's vaccine was shown to be effective in phase 3 of the coronavirus study, according to the drugmaker. What's next now?


Pfizer: Covid-19 Vaccine, More Than 90% Effective 0:56

(CNN Spanish) -

The pharmaceutical company Pfizer released this Monday encouraging results about its vaccine against the coronavirus.

The study, which is in phase 3, demonstrated effectiveness in more than 90% of the volunteers in its clinical study.

In this episode, Dr. Huerta talks about the announcement, the safety of the vaccine, and what we can expect from its implementation.

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 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 that Pfizer's vaccine against covid-19 shows promising initial results.

The Pfizer ad

In a press release - not a scientific study - the pharmaceutical company announced on Monday that its vaccine has been shown to be more than 90% effective in preventing infection by the new coronavirus in volunteers from phase 3 of its clinical study.

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Regarding the safety of the vaccine, the statement only mentions that the side effects have been mild.

but a more detailed report is expected in the coming weeks.

Undoubtedly, this is good news since it indicates that the way to get an effective vaccine is the right one.

If we make a very simple comparison, it is as if the flight path of an airplane that goes from South America to the United States indicates that we are going north.

In other words, we are on the right path.

As we described in the July 16 episode, Pfizer's vaccine uses the same technology from the Moderna company and uses a human gene sequence that produces antibodies against the spike of the new coronavirus.

When injected into humans, this genetic sequence, encoded in a messenger RNA molecule, has shown - both in preclinical studies in cells and in animals and in clinical studies in humans - that it is capable of stimulating the production of antibodies against the spike. of the coronavirus.

Those antibodies, called neutralizing antibodies, are what protect against infection and are what explain the good results in the Pfizer press release.

Pfizer vaccine: why is it effective?

But how did they come to the conclusion that it is effective in more than 90% of cases?

Let's remember that, as we mentioned in the episode of August 19, when a phase 3 study of vaccines is done, half of the volunteers receive a dose and the other half receive a placebo.

Once the injections are received, the volunteers are instructed to lead their normal lives and it is expected that some of them, both in the group that received the vaccine and in the placebo group, will become infected and develop covid-19.

What the Adverse Effects and Data Monitoring Board then does - a group of independent scientists who evaluate the effectiveness and safety of vaccines - is meet from time to time to analyze the data.

In the Pfizer statement it is specified that since the phase 3 study of its vaccine began on July 27, almost 44,000 people have been enrolled in the United States, Brazil, Argentina and Germany, of which 94 have contracted COVID-19.

The analysis showed that less than 10% of the infections occurred in the volunteers who received the vaccine candidate, while more than 90% of the cases occurred in the volunteers who received the placebo.

And now, what is the next step?

According to Pfizer, at the end of November it will be in a position to submit its application for emergency use to the US Food and Drug Administration (FDA) which, in addition to analyzing the scientific data, will examine also aspects related to the production and distribution of the vaccine.

The company estimates that there will be between 15 and 20 million doses in the United States by the end of the year to vaccinate those most at risk of infection, such as health professionals, police officers and firefighters.

Pfizer also estimates that by the end of 2021 it will be able to produce 1.3 billion doses.

Undoubtedly, one of the distribution aspects that will be closely examined by the FDA is that which refers to the storage of the vaccine, which requires extreme freezing of minus 70 degrees Celsius and can be active for less than 24 hours at a temperature between 2 and 8 degrees Celsius.

Few places — especially in low-income countries — have such extreme cooling systems, which is why Pfizer has designed portable refrigerators with built-in GPS that reports the temperature of the equipment.

What remains now is to wait for the final evaluation, which will be achieved when 164 of the more than 44,000 volunteers become infected and it will also be possible to know if, in addition to protecting from infection, the vaccine can protect from a more serious infection and the people who they have been infected before.

BioNtech, a Pfizer partner in the study, told Reuters that the vaccine, which requires two doses three weeks apart, would provide protection for at least one year, so it would be necessary to be vaccinated annually.

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.

If you think this podcast is helpful, help others find it by rating and reviewing it on your favorite podcast app.

We will be back tomorrow so be sure to subscribe to get the latest episode on your account.

And for the most up-to-date information, you can always head over to CNNEspanol.com.

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.

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Source: cnnespanol

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