US companies to test vaccines for young children

Pfizer and Moderna are testing their COVID-19 vaccines in children under 12 years and are expected to have results in hand for children age 5 through 11 by September.

Pfizer announced on Tuesday that it was moving to test its vaccine in children age 5 through 12. It will begin testing the vaccine in infants as young as 6 months in the next few weeks.

The company hopes to apply to the Food and Drug Administration (FDA) in September for emergency authorization of the vaccine for children age 5 to 11. Results for children age 2 through 5 could be available soon after that, according to Kit Longley, a spokesman for Pfizer.

Data from the trial for children between 6 months old and 2 years old could arrive in October or November, followed by a potential submission to the FDA shortly thereafter, Longley said.

Compared with adults, children are much less likely to develop severe illness following infection with the coronavirus. But nearly 4 million children in the US have tested positive for the virus since the start of the pandemic, according to the American Academy of Pediatrics.

In March, Moderna began testing varying doses of its vaccine in younger children. That trial aimed to enroll 6,750 healthy children in the United States and Canada. Results are not expected till the end of the summer, and the vaccine's authorization by the FDA will take longer.

"I think it's going to be early fall, just because we have to go down in age very slowly and carefully," Moderna CEO Stéphane Bancel said Monday.

As countries plead with the US and other wealthier nations to share COVID-19 vaccines, the US is struggling to use up its supply, and there is concern that doses of the Johnson & Johnson's vaccine may expire this month.

Andy Slavitt, a White House pandemic adviser, said at a news conference Tuesday that the federal government is encouraging governors to consult with the FDA on storage procedures as the agency looks at how to possibly extend the shelf life of the vaccine.

Slavitt said it was unrealistic to expect that the US could avoid wasting some vaccine doses, adding that any expired J&J doses wouldn't significantly affect the administration's efforts to help other countries.

"There is a very, very small fraction of doses that have been sent out to states that will ultimately not be used," he said. "These will be fractional amounts and really will not have any significant bearing on our ability to commit to distribute vaccines globally."

J&J hasn't commented.

Dr Marcus Plescia, who represents state health agencies as the chief medical officer for the Association of State and Territorial Health Officials, said he believed the expiration risk for J&J was a problem in every state. More than 10 million doses of the vaccine have been delivered to states but not administered, according to the Centers for Disease Control and Prevention.

Ohio Governor Mike DeWine has asked health providers in his state to use around 200,000 doses of the vaccine that he said were set to expire June 23. The state's health department told providers to make sure doses with earlier expiration dates were used first.

Ohio officials said this week that they weren't legally allowed to send the doses to other states or countries. Once vaccines are shipped out to states, federal regulations prohibit recalling them even if they are not needed domestically.

The single-dose J&J vaccine can be stored at normal refrigeration temperatures for three months, conditions that have allowed states to reach more isolated communities that may find it more difficult to manage the two-dose vaccines made by Pfizer-BioNTech and Moderna, which have stricter storage requirements.

As of Monday, providers were administering about 1.13 million doses per day on average, around a 67 percent decrease from the peak of 3.38 million reported on April 13. About 64 percent of American adults have received at least one shot, according to federal data.

To increase vaccinations, Washington state will offer adults a free marijuana joint when they receive a COVID-19 shot.

The state's liquor and cannabis board announced Monday that the promotion, called "Joints for Jabs", was effective immediately and would run through July 12.

The board said it would allow participating marijuana retailers to provide customers who are 21 or older with a joint at their stores when they received their first or second dose at an active vaccine clinic. The promotion applies only to joints, not to other products like edibles.

An Arizona dispensary recently announced free marijuana joints or gummy edibles to Arizonans 21 and older who receive a vaccination.