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Coronavirus Update: FDA says Pfizer three-shot vaccine is safe for children under 5, ahead of panel meeting that will also review Moderna’s two-shot regimen


Federal health officials said Sunday that Pfizer’s COVID-19 vaccine appears safe and effective for children below the age of 5, clearing another hurdle on the path toward adding that group to the nation’s vaccine program.

The FDA posted its analysis of the Pfizer

shot ahead of a Wednesday meeting where outside experts will vote on whether the shots are ready for the 18 million children between 6 months and 5 years old living in the U.S., as the Associated Press reported.

 Late last week, the FDA posted a similar analysis of the Moderna

vaccine in very young children. If regulators clear the shots by one or both companies, vaccinations could begin as soon as next week with the drug makers ready to rapidly ship doses ordered by the government. Parents have been pressing federal officials for months for the opportunity to protect their smallest children as more adults shed masks and abandon other public health precautions.

Read also: COVID patients with weak immune systems should get priority care to avoid new variants emerging, experts say

While only about 3% of U.S. COVID cases are in the age group between 6 months to 4 years, hospitalization and death rates in that group are higher than those for older children, according to the FDA’s analysis — one reason experts have said protecting this group is so important.

The Pfizer vaccine for small children involves three shots that appeared 80% effective in preventing symptomatic illness, although that was based on just 10 cases among study participants and before the highly transmissible omicron variant emerged.

Moderna’s vaccine for small children involves just two shots and was 40% to 50% effective at preventing milder infections. It was tested during the omicron wave.

The news comes as U.S. cases are averaging 103,193 a day, down 6% from two weeks ago, according to a New York Time’s tracker. That number is widely held to be undercounted, as many people are now testing at home and the test data are not being collected.

But conditions are improving in northeastern U.S. states that were recent hot spots, while the South and West are turning into hot spots. Cases have more than doubled in the last two weeks in Wyoming and Oklahoma.

The country is averaging 29,753 hospitalizations a day, up 10% from two weeks ago with more happening in the South and West. The daily death toll has fallen to 331 on average, down 11% from two weeks ago.

If you’ve had Covid before, why can you get it again? WSJ’s Daniela Hernandez explains what the possibility of reinfections means for the future of public-health policy and the Covid-19 pandemic. Illustration: David Fang

In other medical news, Sanofi


said preliminary data show that its experimental next-generation COVID-19 booster provided a 40-fold increase in antibody protection against BA.1, a subvariant of omicron, in adults who had been previously vaccinated with the mRNA shots. Next-generation vaccines and boosters are based on newer variants of SARS-CoV-2, compared with the currently available vaccines, which were designed to protect against the original strain of the virus first detected in 2019. 



said it proposed a remediation plan to the European Commission after learning of plans to terminate the purchase agreement for Valneva’s COVID-19 vaccine candidate.

If the agreement reduces the total amount of vaccine in the order, that will impact the sustainability of the company’s vaccine program, the company said.

Valneva’s vaccine uses a different technology than the mRNA vaccines. It is an inactivated whole virus shot, which has been viewed as an alternative option for people who are concerned about mRNA technology.

“We continue to receive messages from people looking for a more traditional vaccine technology and we hope to receive a meaningful order size to further support public health in Europe,” Valneva CEO Thomas Lingelbach said in a news release. 

Coronavirus Update: MarketWatch’s daily roundup has been curating and reporting all the latest developments every weekday since the coronavirus pandemic began

Other COVID-19 news you should know about:

• Japan has the lowest number of COVID deaths per capita among wealthy nations, according to new data, with health experts citing the country’s mask habit and low obesity rate as possible reasons, the Wall Street Journal reported. As of Sunday, Japan’s cumulative deaths per million population stood at 245, according to Our World in Data, a website that tallies COVID-19 statistics. That is the lowest figure among the 38 member states in the Organization for Economic Cooperation and Development, a club of wealthy nations that includes the U.S. and most of Europe.

• China’s capital Beijing has put school online in one of its major districts amid a new COVID-19 outbreak linked to a nightclub, the AP reported. A total of 166 cases have been linked to the Heaven Supermarket club in the downtown Gongti nightlife area after an infected person visited there Thursday. Of those, 145 were customers, while the rest were staff or people with whom customers had later contact. The entire area, along with the adjacent Sanlitun shopping and dining complex, was shut down until further notice.

• The head of the World Trade Organization predicted a “bumpy and rocky” road as it opened its highest-level meeting in 4½ years on Sunday, with issues like pandemic preparedness, food insecurity and overfishing of the world’s seas on the agenda, the AP reported separately. At a time when some question WTO’s relevance, Director-General Ngozi Okonjo-Iweala hopes the member nations, which make decisions by consensus, can strike an agreement about whether to temporarily waive WTO’s protections of intellectual property on COVID-19 vaccines.

• United Airlines Holdings Inc. 

 and Delta Air Lines Inc.

stand benefit the most from a lifting of the COVID test requirement for international travelers that took place on Sunday, a Wall Street analyst said Friday. The two could see tailwinds for their transatlantic flight corridors, among the most lucrative and busiest for the legacy airlines. “The testing requirement has been pointed to as one of the major impediments to unlocking travel demand, particularly on the corporate side, across the Atlantic,” Jefferies analyst Sheila Kahyaoglu said in a note.

Here’s what the numbers say

The global tally of confirmed cases of COVID-19 topped 535.3 million on Friday, while the death toll rose above 6.3 million, according to data aggregated by Johns Hopkins University.

The U.S. leads the world with 85.5 million cases and 1,011,277 fatalities.

The Centers for Disease Control and Prevention’s tracker shows that 221.7 million people living in the U.S. are fully vaccinated, equal to 66.8% of the total population. But just 104.4 million have had a first booster, equal to 47.1% of the vaccinated population.

Just 15.6 million of the people aged 50 and over who are eligible for a second booster have had one, equal to 24.7% of those who had a first booster.

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