Phase 3 testing begins for for the two leading vaccine companies …..
One of the first large studies of safety and effectiveness of a coronavirus vaccine in the United States began on Monday morning, according to the National Institutes of Health and the biotech company Moderna, which collaborated to develop the vaccine.
The study, a Phase 3 clinical trial, is to enroll 30,000 healthy people at about 89 sites around the country. Half will receive two shots of the vaccine, 28 days apart, and half will receive two shots of a saltwater placebo. Neither the volunteers nor the medical staff giving the injections will know who is getting the real vaccine.
Researchers will then monitor the subjects, looking for side effects and waiting to see if significantly fewer vaccinated people get Covid-19, indicating that the vaccine works. The main goal is to determine whether the vaccine can prevent the illness. The study will also try to find out if it can prevent severe Covid-19 and death; if it can prevent infection entirely, based on lab tests; and if just one shot can prevent the illness.
Earlier tests of the vaccine showed that it stimulated a strong immune response, with minor and transient side effects like sore arms, fatigue, achiness and fever. But exactly what type of immune response is needed to prevent the illness is not known, so Phase 3 studies are essential to determine whether a vaccine really works.
In a statement, Dr. Francis Collins, the director of the N.I.H., said, “Having a safe and effective vaccine distributed by the end of 2020 is a stretch goal, but it’s the right goal for the American people.” He said that despite the unprecedented speed in bringing this experimental vaccine to human testing, “the most stringent safety measures” were being maintained.
Moderna said in a statement that it would be able to deliver about 500 million doses per year, and possibly up to a billion doses per year, starting in 2021. The company says it will not sell the vaccine at cost, but for profit.
The government announced last week that it had made a $1.95 billion deal to buy 100 million doses of an mRNA vaccine made by Pfizer, in partnership with a German company, BioNTech. That vaccine is also expected to begin Phase 3 trials this month, and the government will buy it only if the trial proves it safe and effective. Curevac and Sanofi are also working on mRNA vaccines.
Moderna said on Sunday that it would receive up to $472 million in additional funding from the federal government to help pay for the late-stage clinical trial. Hundreds of vaccines are being tested for the coronavirus, and 27 are in human trials. The federal government has been promising billions of dollars to companies to quickly develop and manufacture vaccines as part of Operation Warp Speed. In addition to Pfizer and Moderna, Novavax has entered a $1.6 billion deal. Other companies that have received significant federal money include AstraZeneca and Johnson & Johnson. The total value of Moderna’s award is now $955 million, the company said.
Meanwhile things continue to get worst in the South with their governors steadfastly following Trump’s political approach to the virus instead of health officials warnings and guidance…The NorthEast from New Jersey upward is moving slowly back to some sort of normal…That is with mask usage….
With Kentucky officials set to announce stricter measures on Monday to contain the coronavirus, a top federal health official suggested that the leaders of nearby states should take a hard look at doing the same.
Deborah L. Birx, the Trump administration’s coronavirus response coordinator, said several states in the region should reinstate bar closures and restrictions on public gatherings “to really make it possible to control the pandemic before it gets worse.”
States in the South and Midwest are facing the prospect of shutting down parts of their economies again to try to stem the virus, which the Trump administration and many governors have increasingly been forced to recognize as unrelenting. Larry Kudlow, the president’s economic adviser, said Sunday on CNN that the administration would “lengthen” the eviction moratorium which was set to expire at the end of July.
Florida has surpassed New York, an early epicenter of the pandemic in the United States, in the number of cases, and four states have set single-day records for infections: Louisiana, Tennessee, Oklahoma and Alaska….
Drugmaker Pfizer on Monday became the second drugmaker to announce it had begun phase 3 testing of a vaccine to prevent the spread of coronavirus.
CNBC reported that the company, along with German biotech company BioNTech, announced the beginning of human trials involving 30,000 patients in 39 U.S. states and elsewhere around the world.
“Many steps have been taken towards this important milestone and we would like to thank all those involved for their extraordinary commitment,” said Ugur Sahin, CEO of BioNTech, according to CNBC.
The COVID-19 trials, he added, reflects the company’s “primary goal to bring a well-tolerated, highly effective vaccine to the market as quickly as possible, while we will continue to evaluate our other vaccine candidates as part of a differentiated COVID-19 vaccine portfolio.”
The two companies received nearly $2 billion in funding from the U.S. government for the vaccine’s development and production under Operation Warp Speed, a partnership between a number of top health authorities in the U.S. including the Department of Health and Human Services (HHS).
News of Pfizer and BioNTech’s decision to begin human trials closely follows the announcement earlier Monday of the launch of a phase 3 trials of a vaccine developed by drugmaker Moderna and the National Institute of Allergy and Infectious Diseases. That study will also enroll about 30,000 people.
About 25 vaccines for the coronavirus are in the clinical testing phase around the world, according to the World Health Organization….