COVID-19: Virus Vaccine Put To Phase Three Human Trial In Thousands Of Volunteers

Washington: The world’s biggest COVID-19 vaccine study got underway Monday with the first of 30,000 planned volunteers helping to test shots created by the U.S. government — one of several candidates in the final stretch of the global vaccine race. There’s still no guarantee that the experimental vaccine, developed by the National Institutes of Health and Moderna Inc, will really protect. The needed proof: Volunteers won’t know if they’re getting the real shot or a dummy version.

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After two doses, scientists will closely track which group experiences more infections as they go about their daily routines, especially in areas where the virus still is spreading unchecked. “Unfortunately for the United States of America, we have plenty of infections right now” to get that answer, NIH’s Dr Anthony Fauci recently told The Associated Press.

Several other vaccines made by China and by Britain’s Oxford University earlier this month began smaller final-stage tests in Brazil and other hard-hit countries. But the US requires its own tests of any vaccine that might be used in the country and has set a high bar: Every month through fall, the government-funded COVID-19 Prevention Network will roll out a new study of a leading candidate — each one with 30,000 newly recruited volunteers.

The massive studies aren’t just to test if the shots work — they’re needed to check each potential vaccine’s safety. And following the same study rules will let scientists eventually compare all the shots.

Next up in August, the final study of the Oxford shot begins, followed by plans to test a candidate from Johnson & Johnson in September and Novavax in October — if all goes according to schedule. Pfizer Inc. plans its own 30,000-person study this summer. That’s a stunning number of people needed to roll up their sleeves for science.

But in recent weeks, more than 150,000 Americans filled out an online registry signalling interest, said Dr. Larry Corey, a virologist with the Fred Hutchinson Cancer Research Institute in Seattle, who helps oversee the study sites.

These trials need to be multigenerational, they need to be multiethnic, they need to reflect the diversity of the United States population, Dr. Corey told a vaccine meeting last week.

Also Read: Coronavirus Vaccine: Oxford University’s COVID-19 Vaccine Candidate Exhibits Strong Immune Responses, Says The Lancet Study

He stressed that it’s especially important to ensure enough Black and Hispanic participants as those populations are hard-hit by COVID-19. It normally takes years to create a new vaccine from scratch, but scientists are setting speed records this time around, spurred by knowledge that vaccination is the world’s best hope against the pandemic.

The coronavirus wasn’t even known to exist before late December, and vaccine makers sprang into action Jan 10 when China shared the virus’ genetic sequence. Just 65 days later in March, the NIH-made vaccine was tested in people. The first recipient is encouraging others to volunteer now.

We all feel so helpless right now. There’s very little that we can do to combat this virus. And being able to participate in this trial has given me a sense of, that I’m doing something. Be prepared for a lot of questions from your friends and family about how it’s going, and a lot of thank-you’s, Jennifer Haller of Seattle told the AP.

That first-stage study that included Ms. Haller and 44 others showed the shots revved up volunteers’ immune systems in ways scientists expect will be protective, with some minor side effects such as a brief fever, chills and pain at the injection site. Early testing of other leading candidates have had similarly encouraging results. If everything goes right with the final studies, it still will take months for the first data to trickle in from the Moderna test, followed by the Oxford one.

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NDTV – Dettol Banega Swasth India campaign is an extension of the five-year-old Banega Swachh India initiative helmed by Campaign Ambassador Amitabh Bachchan. It aims to spread awareness about critical health issues facing the country. In wake of the current COVID-19 pandemic, the need for WASH (Water, Sanitation and Hygiene) is reaffirmed as handwashing is one of the ways to prevent Coronavirus infection and other diseases. The campaign highlights the importance of nutrition and healthcare for women and children to prevent maternal and child mortality, fight malnutrition, stunting, wasting, anaemia and disease prevention through vaccines. Importance of programmes like Public Distribution System (PDS), Mid-day Meal Scheme, POSHAN Abhiyan and the role of Aganwadis and ASHA workers are also covered. Only a Swachh or clean India where toilets are used and open defecation free (ODF) status achieved as part of the Swachh Bharat Abhiyan launched by Prime Minister Narendra Modi in 2014, can eradicate diseases like diahorrea and become a Swasth or healthy India. The campaign will continue to cover issues like air pollution, waste management, plastic ban, manual scavenging and sanitation workers and menstrual hygiene.