Day: June 15, 2022

COVID-19 shots for U.S. infants, toddlers and preschoolers moved a step closer Wednesday.

The Food and Drug Administration’s outside vaccine advisers gave a thumbs-up to Moderna’s two shots for the littlest kids. The panel is set to vote later Wednesday on whether to also recommend Pfizer’s three-shot series for those youngsters.

The outside experts voted unanimously that the benefits of Moderna’s shots outweigh any risks for children under 5 — that’s roughly 18 million youngsters.

They are the last remaining group in the U.S. to get vaccinated, and many parents have been anxious to protect their little children. If all the regulatory steps are cleared, shots should be available next week.

“This is a long-awaited vaccine,” said panel member Dr. Jay Portnoy of Children’s Hospital in Kansas City, Missouri. “There are so many parents who are absolutely desperate to get this vaccine, and I think we owe it to them to give them a choice to have the vaccine if they want to.”

Dr. Peter Marks, FDA’s vaccine chief, opened the meeting with data showing a “quite troubling surge” in young children’s hospitalizations during the omicron wave, and noted that 442 children under 4 have died during the pandemic. That’s far fewer than adult deaths but should not be dismissed in considering the need for vaccinating the youngest kids, he said.

“Each child that’s lost essentially fractures a family,” Marks said.

FDA reviewers said both brands appear to be safe and effective for children as young as 6 months old in analyses posted ahead of the all-day meeting. Side effects, including fever and fatigue, were generally minor in both, and less common than seen in adults.

The two vaccines use the same technology, but there are differences. In a call with reporters earlier this week, vaccine experts noted that the shots haven’t been tested against each other, so there’s no way to tell parents if one is superior.

“That is a really important point,”‘ said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief. “You can’t compare the vaccines directly.”

If the FDA agrees with its advisers and authorizes the shots, there’s one more step. The Centers for Disease Control and Prevention will decide on a formal recommendation after its own advisers meet Saturday. If the CDC signs off, shots could be available as soon as Monday or Tuesday at doctor’s offices, hospitals and pharmacies.

Pfizer’s vaccine is for children 6 months through 4 years. Moderna’s vaccine is for 6 months through 5 years.

Moderna’s shots are one-quarter the dose of the company’s adult shots. Two doses appeared strong enough to prevent severe illness but only about 40% to 50% effective at preventing milder infections. Moderna has added a booster to its study and expects to eventually offer one.

Pfizer’s shots are just one-tenth its adult dose. Pfizer and partner BioNTech found that two shots didn’t provide enough protection in testing, so a third was added during the omicron wave.

Pfizer’s submitted data found no safety concerns and suggested that three shots were 80% effective in preventing symptomatic coronavirus infections. But that was based on just 10 COVID-19 cases. The calculation could change as more cases occur in the company’s ongoing studies.

The same FDA panel on Tuesday backed Moderna’s half-sized shots for ages 6 to 11 and full-sized doses for teens. If authorized by the FDA, it would be the second option for those age groups. Currently, the Pfizer vaccine is their only choice.

The nation’s vaccination campaign started in December 2020 with the rollout of adult vaccines from Pfizer and Moderna, with health care workers and nursing home residents first in line. Teens and school-age children were added last year.

Moderna said in April that it is also seeking regulatory approval outside the U.S. for its little kid shots. According to the World Health Organization, 12 other countries already vaccinate kids under 5, with other brands.

In the U.S., it remains uncertain how many parents want their youngest children vaccinated. While COVID-19 is generally less dangerous for young children than older kids and adults, there have been serious cases and some deaths. Many parents trying to keep unvaccinated tots safe have put off family trips or enrolling children in day care or preschool.

Still, by some estimates, three-quarters of all children have already been infected. Only about 29% of children ages 5 to 11 have been vaccinated since Pfizer’s shots opened to them last November — a rate far lower than public health authorities consider ideal.

Dr. Nimmi Rajagopal, a family medicine physician at Cook County Health in Chicago, said she’s been preparing parents for months.

“We have some that are hesitant, and some that are just raring to go,” she said.

Source: Voice of America

During the early months of the pandemic, the Chinese government developed a color-coded smartphone app to track the movement of people in its effort to control the spread of COVID-19 and implement its zero-COVID policy.

This week, however, media reports surfaced that authorities in Zhengzhou, the capital of Henan province, were now using the required codes to restrict the movement of people upset because local banks had frozen their deposits.

Hundreds of depositors who had lost access to their funds had planned to travel to Zhengzhou on Monday, only to find their health codes had suddenly turned red. This meant they couldn’t travel, and the protests fizzled. The red code seemed to target only depositors, according to CNN.

VOA Mandarin asked China’s Foreign Ministry for comment on the government’s alleged new use for the app but received no comment.

The state-run Global Times ran an editorial on Tuesday saying, “The health code is a technical means designed to make the public compromise some personal information rights to comply with the needs of society’s public health security. It can only be used for epidemic prevention purposes. It is the responsibility of the relevant authorities to protect the privacy of citizens to the greatest extent during the epidemic prevention process.”

Hu Xijin, the former editor-in-chief of Global Times, posted on his Weibo microblog that the “red code issue is very disturbing,” and that any non-COVID-related use would be a “clear violation” of virus prevention measures.

Ever since China began promoting the portable and personalized health codes in response to the coronavirus outbreak, some people have speculated that the technology could be used as a political tool to restrict mobility. The app tracks a user’s travel, contact history and biometric data, such as temperature, through a smartphone.

Alex Gladstein, chief strategy officer at the New York-based Human Rights Foundation, said on Twitter, “I would have actually thought this happened more routinely in the past two years but apparently this is a watershed moment for using health tools to crack down on dissent.”

Another comment came from James Palmer, a former Beijing resident who is now deputy editor at Foreign Policy, who tweeted, “This is significant because — afaik (as far as I know) — it’s the first clear story we have of the health code system being used for non-Covid political control.”

The app uses a QR code to track a user’s movements in order to monitor exposure to known cases of the virus, according to a blog post at Center for Strategic and International Studies, a Washington think tank. Authorities throughout China required residents to provide their names and ID numbers and register for facial recognition to obtain the QR code linked to their identity.

If the QR code glows green, the user has had no contact with an infected person and can move around. An amber code means the user is required to quarantine at home for seven to 14 days, Those with red codes are to be treated and quarantined either at home or in a centralized location, according to CSIS.

It has become routine for Chinese to show the code in order to gain entry to housing compounds, theaters and restaurants, and public transportation.

According to reports by Reuters and other media, the depositors who had planned to protest in Zhengzhou said their most recent COVID-19 test results were negative, and that officials refused to explain why their health codes turned red.

Rina Chandran, a journalist at Thomson Reuters Foundation in India, tweeted, “This is what can happen when the govt controls your data: #China Covid app overnight restricts residents who need the health code to enter buildings and shops, use public transport, or leave the city.”

The Henan Provincial Health Commission told The Paper, a state-run news website, that it was “investigating and verifying” the complaints from depositors who received red codes.

Anouk Eigenraam, China correspondent at Het Financieele Dagblad/Algemeen Dagblad, tweeted, “This red health codes is exactly the reason why China will keep this 0 covid alive a long time. It’s to useful as a tool for control. I’ve been saying this for a year and many people kept saying ‘but the economy’, well as we saw they’re very willing to take a hit.”

Source: Voice of America