These 3 Covid-19 faxes have been in the news. Here’s what you need to know about them

08/12/2020 Health, World


Here’s what you need to know about them.

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

To speed up the process, the U.S. Government’s Operation Warp Speed ​​provides some funding for those three and five others – vaccine candidates call the U.S. Department of Health and Human Services “the most promising.”

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

While the Phase 1 trial results are promising, there will be evidence in the results of the final, large-scale Phase 3 trials. If a vaccine candidate does this, it will go to the U.S. Food and Drug Administration for approval.

Phase 1 studies include 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 step before you seek approval and seek safety, efficacy and optimal dosage. For coronavirus, they are all planned to involve 30,000 people.

President Donald Trump said last week that he is optimistic that a fax will be available by the November 3 presidential election. Experts told CNN, though, it is highly unlikely that one of the two U.S. companies with a vaccine candidate now in Phase 3 testing will have vaccines ready for then, given the status and timelines of their tears now.

Modern

Where is it now? The launch of Moderna’s Phase 3 trial of its mRNA-1273 vaccine was announced just last week. It will involve 30,000 adults at 89 clinical research sites around the country. It is the first Phase 3 trial started during Operation Warp Speed, according to the National Institutes of Health.

Phase 2 was started in May.

Test results: So far, only Phase 1 results have been released. Those early results showed that the vaccine elicited an immune response, which is what researchers wanted to see. The higher the dose, the higher was 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 aches, and pain at the injection site. These are considered normal side effects for a vaccine. The higher the dose, the less the side effects. The Phase 3 trial will use the middle dose.

Who develops it? Moderna, a biotech based in Cambridge, Massachusetts, developed the vaccine with the help of the National Institute of Allergy and Infectious Diseases, part of the American National Institute of Public Health.

Pfizer

Where is it now? Pfizer has more than one vaccine candidate, is being developed together with the German company BioNTech. It has gone through a combined phase 2/3 trial, also started last week, with one of them, BNT162b2. It is carried out in about 120 places worldwide, 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 regulatory review since October. If it receives emergency authorization from the FDA, as many as 100 million doses may be available by the end of the year, and about 1.3 billion by the end of 2021.

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

Test results: In the combined Phase 1/2 trial, both vaccines elicited 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 moved on to more advanced tears. Nearly 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 one to two days, “such as fever , fatigue and chills and no serious adverse events. “

Novavax

Where is it now? Biotech in Maryland Novavax hopes to have its vaccine in Phase 3 studies next month.

Test results: Novavax published data from its Phase 1 trial on Tuesday involving 131 participants. After two doses of the vaccine, participants had levels of antibodies that could fight the virus, which was on average four times higher than those developed by people recovering from Covid-19.

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

How safe is it? Of the 106 people who received the vaccine, and no placebo, five had serious side effects, including muscle aches, nausea and joint pain, and one had a mild fever. The side effects lasted on average two days or less.

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

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