These 3 Covid-19 vaccines have made the headlines. Here’s what you need to know about them

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Here’s what you need to know about them.

These are among dozens of Covid-19 vaccines being tested across the world as researchers rush to find a way to stop the pandemic.

To speed up the process, the US government’s Operation Warp Speed ​​is providing funding for these three and five more – candidate vaccines 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 safe and effective vaccine by January 2021.

While the results of the Phase 1 trial are promising, the evidence will be in the results of the major Phase 3 final trials. If a vaccine candidate succeeds, it will be submitted to the U.S. Food and Drug Administration 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 various potential doses. Phase 3 trials are a final step before seeking approval and pursuing safety, efficacy, and optimal dosage. For the coronavirus, they should all involve 30,000 people.

Modern

Where is he 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. This is the first Phase 3 trial started as part of Operation Warp Speed, according to the National Institutes of Health.

Phase 2 started in May.

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

Is it safe? More than half of the participants experienced side effects, including fatigue, chills, headaches, muscle aches, and pain at the injection site. These are considered normal side effects for a vaccine. The higher the dose, the worse the side effects. The Phase 3 trial will use the mid dose.

Who develops it? Moderna, a biotechnology company based in Cambridge, Massachusetts, developed the vaccine with help from the National Institute of Allergy and Infectious Diseases, which is part of the National Institutes of Health in the United States.

Pfizer

Where is he now? Pfizer has more than one vaccine candidate, in development with the German company BioNTech. It has moved to a combined phase 2/3 trial, also started last week, with one of them, BNT162b2. This is done at approximately 120 locations around the world, including 39 US states and Argentina, Brazil and Germany.

When will we get it? If the trial is successful, Pfizer and BioNTech said they were on track to seek regulatory review as early as October. If it gets emergency clearance from the FDA, up to 100 million doses could be available by the end of the year, and about 1.3 billion by the end of 2021.

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

Test results: In the combined Phase 1/2 trial, the two vaccines elicited an immune response and produced antibodies, a “two-armed” approach the companies hope will be more effective and provide longer protection. So far only one has moved on to more advanced testing. Almost 120 people attended.

Is it safe? Preliminary data from the Phase 1/2 trial showed “a favorable overall safety profile” for the vaccine, Pfizer said in a press release, “with generally mild to moderate side effects that lasted one to two. days’, such as fever, fatigue and chills and no serious adverse events. “

Novavax

Where is he now? Biotech based in Maryland Novavax hopes to have its vaccine in phase 3 trials next month.

Test results: Novavax released data from its Phase 1 trial involving 131 participants on Tuesday. After two doses of the vaccine, participants had levels of antibodies capable of fighting the virus that were four times higher, on average, than those developed by people who have recovered from Covid-19.

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

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

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

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