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These three possible vaccines for covid-19 have been in the news. This is what you need to know about them

2020-08-11T13:11:04.333Z


The United States Government is investing billions in vaccines against COVID-19 and the candidates of three companies are moving fast: Moderna, Pfizer and Novavax.


This is how the race for the covid-19 vaccine goes 1:52

(CNN) - The United States government is investing billions in vaccines against covid-19 and the candidates of three companies are moving quickly: Moderna, Pfizer and Novavax.

This is what you need to know about them.

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These are among dozens of COVID-19 vaccines in trials around the world as researchers scramble to find a way to stop the pandemic.

To help speed up the process, the US Government's "Operation Warp Speed" provides some funding for those three and five other vaccine candidates that the US Department of Health and Human Services calls "the most promising."

The goal of Operation Warp Speed ​​is to have 300 million doses of a vaccine that is safe and effective by January 2021.

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While the results of the Phase 1 trial are promising, the proof will be in the results of the final large Phase 3 trials. If a vaccine candidate passes them, she will go to the US Food and Drug Administration. (FDA) for approval.

Phase 1 trials involve testing the vaccine in a small group of people to see if it is safe and effective. Phase 2 trials involve a larger group and often involve several potential doses. Phase 3 trials are a final stage before seeking approval and seeking safety, efficacy, and optimal dosing. For the coronavirus, they are all scheduled to involve 30,000 people.

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Modern

At what point is it now? The start of Moderna's Phase 3 trial of its mRNA-1273 vaccine was announced last week. It will involve 30,000 adults at 89 clinical research sites across the country. It is the first Phase 3 trial that began with Operation Warp Speed, according to the National Institutes of Health.

Phase 2 started in May.

Test results: So far, only the Phase 1 results have been published. Those early results showed that the vaccine elicited an immune response, which is what the researchers wanted to see. The higher the dose, the greater the immune response in the people who received it.

How safe is it? More than half of the participants had side effects, including fatigue, chills, headache, muscle pain, and pain at the injection site. These are considered normal side effects of a vaccine. The higher the dose, the worse the side effects. The phase 3 trial will use the medium dose.

Who is developing it? Moderna, a biotech based in Cambridge, Massachusetts, developed the vaccine with help from the National Institute of Allergy and Infectious Diseases, part of the US National Institutes of Health.

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Pfizer

At what point is it now? Pfizer has more than one vaccine candidate, developed together with the German company BioNTech. It moved to a combined Phase 2/3 test, also started last week, with one of them, the BNT162b2. That takes place at roughly 120 sites around the world, including 39 US states and Argentina, Brazil and Germany.

When will we have it? If the trial is successful, Pfizer and BioNTech have said they are on track to seek a regulatory review as soon as October. If you get emergency clearance from the FDA, up to 100 million doses may be available by the end of the year, and around 1.3 billion by the end of 2021.

The US Department of Health and Human Services and the Department of Defense last month announced a US $ 1.95 billion deal with Pfizer to produce 100 million doses of the vaccine. The agreement also allows the United States Government to purchase an additional 500 million doses.

Test Results: In the combined Phase 1/2 trial, both vaccines produced an immune response and produced antibodies, a "double-arm" approach that companies hope will be more effective and provide longer-lasting protection. So far, only one has gone to more advanced testing. Almost 120 people participated.

How safe is it? Preliminary data from the Phase 1/2 trial showed "a favorable overall tolerability profile" for the vaccine, Pfizer said in a news release, "with generally mild to moderate side effects lasting a day or two," such as fever, fatigue and chills and no serious adverse events. '

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Novavax

At what point is it now? Maryland-based biotech company Novavax expects to have its vaccine in phase 3 trials next month.

Test Results: Novavax released data from its Phase 1 test on Tuesday with 131 participants. After two doses of the vaccine, the participants had levels of antibodies that can fight the virus that were four times higher, on average, than those developed by people who recovered from COVID-19.

The vaccine also elicited an immune cell response, according to an analysis of 16 randomly selected volunteers.

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How safe is it? Of the 106 people who received the vaccine, and not a placebo, five had severe side effects, including muscle pain, nausea, and joint pain, and one had a mild fever. Side effects lasted two days or less, on average.

CNN's Elizabeth Cohen, John Bonifield, Jamie Gumbrecht, Mallory Simon, Maggie Fox, and Jacqueline Howard contributed to this report.

Coronavirus vaccine

Source: cnnespanol

All news articles on 2020-08-11

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