‘Ethical Heartburn’: FDA Official Pauses Over Safety Of Exposing Vaccine Trial Patients To COVID
In human challenge studies, people are exposed to the disease. But no cures exist for COVID-19, lethal to vulnerable patients. “If something bad happens, you don’t have a perfect fix for it,” said the FDA's Peter Marks. News on vaccines is on how to volunteer, how it will get to market and more.
Politico:
FDA Official Casts Doubt On 'Challenge Trials' For Covid Vaccine
A top FDA official overseeing vaccine approvals raised doubts Wednesday about the possibility of intentionally infecting people with the coronavirus to see whether vaccines work, saying that could represent “ethical heartburn” because there's still no easy way to treat the potentially severe disease. (Owermohle, 7/8)
Boston Globe:
11 Coronavirus Vaccines To Keep An Eye On
Federal officials have repeatedly expressed optimism that at least one vaccine against the novel coronavirus will be proven effective and ready for market by early 2021. As of July 7, pharmaceutical companies worldwide were working on 160 candidate vaccines, including 21 that are being tested in people, according to the World Health Organization. ... Each prospective vaccine goes through three phases of study in humans. To speed the process, some vaccine developers are conducting two of the phases simultaneously. Here’s an overview of each phase. (Freyer and Saltzman, 7/9)
The Hill:
US Investing $42M To Help Company Ramp Up Syringe, Needle Production Ahead Of Vaccination Push
The U.S. government is investing $42 million to help Becton, Dickinson and Company, known as BD, ramp up its production of syringes and needles ahead of the future coronavirus vaccination push. The U.S.’s Biomedical Advanced Research and Development Authority (BARDA), committed to providing $42 million for a $70 million project to expand BD’s manufacturing operations in Nebraska, according to a press release. (Coleman, 7/8)
PBS NewsHour:
How A Coronavirus Vaccine Will Get To Market
With new daily case counts of novel coronavirus on the rise in nearly every state, as well as Puerto Rico, the consequences of reopening much of the country without first stopping the spread has made one thing clear: An unlocked United States will likely continue to suffer from the deadly virus until a safe and efficient vaccine is finally distributed to a majority of the population. There are lots of different ways to formulate a vaccine, and all of them are now being considered for coronavirus. Some vaccines use common methods to confer immunity, while others are entirely experimental — they’ve never before been approved for use. (Isaacs-Thomas, 7/8)
CNN:
Covid-19 Vaccine Trials: Here's How To Volunteer
If you want to be one of the first to receive an experimental vaccine for Covid-19, now's your chance. Wednesday, a new website -- coronaviruspreventionnetwork.org -- went live allowing people in the United States to register to take part in clinical trials for vaccines. The website will handle registration for the four large vaccine studies that are expected to start this summer and fall, and any others that follow. (Cohen, 7/8)
In other vaccination news —
Kaiser Health News:
Shingles Vaccination Rate Soars But Leaves Many Behind
Worried about the high cost of the copayment for the shingles vaccine, Jacky Felder, a Medicare beneficiary, opted against getting immunized last year. Last month, the Green Bay, Wisconsin, woman developed the disease, which left a painful, itchy rash across her abdomen. “Luckily, I’ve had a relatively mild case, but it’s been a week and half with a lot of pain,” said Felder, 69. (Galewitz, 7/9)
AP:
WHO Says Sri Lanka And Maldives Eliminate Measles, Rubella
Sri Lanka and Maldives have become the first two countries in the World Health Organization’s South-East Asia region to eliminate both measles and rubella ahead of a 2023 target, the U.N. health agency announced Wednesday. (Mallawarachi, 7/8)
