COVID-19: FDA panel gives green light to Pfizer vaccine

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The advisory panel of the United States Food and Drug Administration (FDA), an independent group of scientists that advises the federal entity, just gave the green light on December 10 to the emergency use of the COVID-19 vaccine. from the Pfizer laboratory.

The FDA always follows the advice of the advisory panel, which means that the vaccine will be applied to risk groups before Christmas.

There were 17 votes in favor, four against and one abstention.

The panel said the benefits outweigh the risks of this vaccine to be given to people 16 years of age and older.

Approval of emergency use means that the FDA accelerates what is often a bureaucratic process that takes a couple of years.

This decision of the panel of experts accelerates the distribution of the vaccine, which is already packaged and ready to be distributed in different hospitals and health centers, and begin to administer it.

In the face of a pandemic, times are accelerating to slow the spread of the coronavirus.

This first vaccine will reach priority groups first, which make up nearly half of the United States population: 21 million health care workers, 3 million residents of long-term care facilities, 66 million essential workers, more than 100 million adults with high-risk conditions and 53 million adults 65 and older.

The challenge for older adults is to organize the vaccination of those who live at home, alone or with a family, as is the case with many Hispanic families.

There are 2 million older adults who cannot leave their homes, and 5.3 million with physical disabilities that prevent them from moving around.

Since initial vaccine supplies are limited, prioritization will be inevitable. In practice, this means that hospitals and doctors would identify older adults who are most at risk of becoming seriously ill from COVID-19 and offer them vaccinations earlier than older adults.

When seeking approval for emergency use, Pfizer’s vaccine was in phase 3 of the research, with more than 44,000 participants in the United States, Brazil, Argentina and Germany.

This vaccine generates a strong immune response in the body that, according to information known the week of November 16, would prevent 94.5% of coronavirus infections.

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It takes two doses to start producing immunity, within a month.

The companies that produce it, Pfizer of the United States and BioNTech of Germany, say they will produce 100 million doses by the end of 2020, and more than 1 billion by the end of 2021.

A challenge, its storage and distribution, since it needs to be kept below 70 degrees farhenheit of temperature.

The following is a list of vaccines that will likely follow Pfizer’s.

Modern

Trial status. It is in phase 3 of the research, with more than 40,000 participants in the United States and Europe. Of these, 5,000 have already received the second dose of the vaccine.

How it works. The vaccine uses genetic material known as RNA to inject into cells a protein found in coronaviruses, which stimulates the production of antibodies in the body.

The pharmaceutical company reported that preliminary results show that the vaccine is effective in 94.5% of cases.

When will it be known if it works. With those efficacy results, the company applied for emergency clearance from the FDA on November 30. There will be a hearing of the FDA advisory panel in a few days.

Required dose. Two, with a difference of 28 days.

Supply. Moderna has said it would produce 20 million doses by the end of 2020 and between 500 million and 1 billion by the end of 2021.

Johnson & Johnson

Trial status. He is in phase 3 of the investigation, after an impass due to the unexpected illness of a participant. It has 60,000 volunteers in 28 US states, Argentina, Brazil, Chile, Colombia, Mexico, Peru and Ukraine. The drugmaker is planning a second trial with 30,000 volunteers in Europe, South Africa, the Philippines and Florida, in the United States, to test two doses of the vaccine.

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How it works. The vaccine uses an inactivated version of the common cold virus to transport genetic material into cells, which prompts the body to produce a coronavirus protein that would trigger an immune response.

When will it be known if it works. In the first months of 2021

Required dose. One dose (although the company says it will begin a trial to test a two-dose vaccine).

Supply. Johnson & Johnson has agreed to sell 300 million doses in the United States, and 200 million in the European Union. It has also promised to target 500 million doses to developing countries, by mid-2021.

AstraZeneca and the University of Oxford

Trial status. He is in phase 3 of the investigation after an impass caused by a volunteer who presented unexplained neurological symptoms. He performs trials in the United States, South Africa, Brazil, Chile, and Peru. 23,000 participants were recruited.

How it works. The vaccine uses a weakened version of the virus that causes the common cold combined with components of the coronavirus. In the first two phases of the research, he showed that the body generates a strong immune response and produces antibodies.

When will it be known if it works. The drugmaker reported on Thanksgiving week that its vaccine showed an average efficacy of 70% in a two-dose regimen, and 90% effective in one dose. This difference in percentages is not yet clear. This vaccine is a potential candidate for distribution in Latin American countries.

Required dose. Two

Supply. AstraZeneca has said it could deliver up to 2 billion doses of the vaccine. The United States, Japan and Australia, among other countries, have already signed agreements with the company to have doses of this vaccine.

Sinovac

Trial status. It is in phase 3 of the investigation, and has already received approval for emergency use in China.

How it works. The vaccine uses a purified and inactive form of the coronavirus combined with a component of another vaccine used for hepatitis B. It has managed to generate antibodies and have special potency in people over 60 years of age.

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When will it be known if it works. Early 2021

Required dose. Two

Supply. The company has said it has the capacity to produce an initial batch of 100 million doses.

CanSino Biologics and the Beijing Institute of Biotechnology

Trial status. It is in phase 3 of the investigation, with trials in Pakistan and several countries in Latin America. This vaccine has the authorization of the Chinese Army.

How it works. It is a modified form of an earlier vaccine, which had been developed against Ebola. It uses an inactivated version of the coronavirus together with genetic material from the common cold, to generate an immune response from the body.

When will it be known if it works. The alliance has not said when further results will be known.

Required dose. Two

Supply. The alliance has not said its production capacity for this vaccine, but Russian pharmaceutical company Petrovax has announced that it can manufacture up to 4 million doses of the vaccine per month in 2020 and up to 10 million doses per month during 2021.

Sputnik V

Trial status. This vaccine already approved in Russia is in phase 3 of research, with 40,000 participants. They have already begun to administer it.

How it works. The vaccine is a combination of two adenovirus vectors. In an analysis published in The Lancet magazine, carried out with 76 participants, it showed an immune response.

When will it be known if it works. There is no information yet on a definitive analysis.

Required dose. Two

Supply. The Russian government has said that it already has agreements with different countries, to generate a production of 500 million doses.

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