Clampdown On J&J Covid Shot Hasn’t Disrupted Vax Rollout, Providers Say

Modern Healthcare: FDA's Limitations On J&J Vaccine Haven't Disrupted Providers
The Food and Drug Administration's decision to limit the use of the Johnson & Johnson COVID-19 vaccine won't have a significant impact on health systems. The FDA scaled back the emergency use authorization of the vaccine developed by J&J and its Janssen Pharmaceuicals subsidiary because it caused a rare blood clotting disorder in 60 patients out of 18.7 million doses administered. The vaccine should only be used for adults who would otherwise go unvaccinated or who cannot have the Pfizer and Moderna vaccines, the agency said. (Kacik, 5/6)

More on the vaccine rollout —

Idaho Capital Sun: Idaho Doctor Who Falsely Links COVID-19 Vaccine To Cancer Has Misdiagnosed Two Patients 
One woman thought she had cancer. Another woman thought she was developing it. There was no cancer. They were misdiagnosed by Dr. Ryan Cole, according to reporting by the Sun. Cole diagnosed the patients in the past year — while claiming to see a spike in cancers at his laboratory and attributing that spike to immune damage from the COVID-19 vaccine. Cole has not publicly produced evidence to support that claim, while experts who refute his claim have shared their evidence and directly debunked his mischaracterizations of their research. (Dutton, 5/6)

WJLA: Parents To Rally In Support Of Vaccine Approval For Children Under Age 6 In Silver Spring 
The group Protect Their Future announced that a group of parents plan to rally outside of Food and Drug Administration (FDA) headquarters in Silver Spring, Maryland on Monday. The parents are demanding an urgent review of the Moderna COVID-19 vaccine for their children. (Powers, 5/9)

AP: Tribes Credited With Elevating Vaccinations In Rural Arizona
Mary Francis had no qualms about being a poster child for COVID-19 vaccinations on the Navajo Nation, once a virus hot spot. The Navajo woman’s face and words grace a digital flyer asking people on the Native American reservation to get vaccinated “to protect the shidine’e (my people).” “I was happy to put the information out there and just building that awareness and in having folks feel comfortable enough, or curious enough, to read the material,” said Francis, who lives in Page, near the Utah border, and manages care packages and vaccine drives for a Navajo and Hopi relief fund. (Tang, 5/7)

In vaccine development news —

CIDRAP: 3 COVID Vaccine Doses Appear To Protect Against Omicron Subvariants 
Three new studies report on COVID-19 vaccine effectiveness (VE) and antibody responses to Omicron, with one from Sweden finding a drop in two-dose VE against severe disease after the transition from the BA.1 to the BA.2 subvariant but three-dose protection remaining above 80% against severe disease. Also, a study from Hong Kong shows good antibody response against BA.2 after three doses, and one from the United States finds that nursing home patients who received a third dose had a 47% lower risk of Omicron infection. (Van Beusekom, 5/6)

Reuters: COVID Vaccine Makers Shift Focus To Boosters
COVID-19 vaccine makers are shifting gears and planning for a smaller, more competitive booster shot market after delivering as many doses as fast as they could over the last 18 months. Executives at the biggest COVID vaccine makers including Pfizer Inc and Moderna Inc said they believe most people who wanted to get vaccinated against COVID have already done so - more than 5 billion people worldwide. In the coming year, most COVID vaccinations will be booster shots, or first inoculations for children, which are still gaining regulatory approvals around the world, they said. (Erman and Misra, 5/9)

The Boston Globe: Covid Shots Made Moderna Biotech’s Biggest Star, But What Now?
What does a breakout company like Moderna do for an encore? More than a decade after its founding, the Cambridge biotech rolled out its first commercial product last year. And what a debut it was: a cutting-edge COVID-19 vaccine that helped to save thousands ― if not millions ― of lives around the world. It was also a massive moneymaker for Moderna, which up until then had been unprofitable. With more than $38 billion in total COVID-19 vaccine sales expected by the end of this year ― many of the doses paid for by governments ― investors are wondering what the company plans to do with that windfall. Despite Moderna’s spectacular success, the question of what’s next looms large, and the pressure is on to avoid becoming a one-hit wonder. (Cross, 5/7)

USA Today: Nasal Vaccines May Be The Next Generation Of Protection Against COVID
Current vaccines are great at stopping severe disease. But people can still catch COVID-19, even after two, three or more shots. Researchers hope a different delivery system will make for a vaccine that is better at preventing transmission and infections. By putting the vaccine directly into the nose, it might prevent the virus from taking hold in the mucus membranes, where it first enters the body. (Weintraub, 5/8)