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US FDA backs Pfizer’s COVID-19 booster shot for 12- to 15-year-olds

The US Food and Drug Administration on Monday authorized the use of a third dose of the Pfizer and BioNTech COVID-19 vaccine for children ages 12 to 15, and narrowed the time for all booster shots by a month to five months after the primary doses.

The agency also authorized a third shot for children aged 5 through 11 years who are immunocompromised.

Read the latest updates in our dedicated coronavirus section.

The regulatory decisions come as schools reopen in much of the country, and as COVID-19 cases surge due to the omicron variant of the virus, with health authorities warning that its high transmissibility could overwhelm many health systems.

The US Centers for Disease Control and Prevention is expected to weigh in on the changes this week, according to the New York Times. The CDC was not immediately available for comment.

“Based on the FDA’s assessment of currently available data, a booster dose of the currently authorized vaccines may help provide better protection against both the Delta and Omicron variants,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

The US government has been urging vaccinated Americans to get boosters and for the unvaccinated, who are at much higher risk of severe COVID-19 and death, to be inoculated.

So far, 62 percent of the eligible US population is considered fully vaccinated with a third of them also having received a booster dose.

In making its decision, the FDA said it reviewed real-world data from Israel, including safety data from more than 6,300 individuals aged 12 through 15 years who received a booster dose of the Pfizer-BioNTech vaccine at least 5 months following completion of the primary two-dose vaccination series.

There were no new cases of a rare type of heart inflammation reported to-date in these individuals, the FDA said.

Laboratory tests have shown that two doses of the Pfizer-BioNTech and Moderna vaccines generate low immune responses against Omicron, while the addition of a booster appears to restore protection against the highly-mutated variant.

Two shots of the mRNA vaccine are about 35 percent effective against infection from the Omicron variant, but a booster dose restores effectiveness to 75 percent, according to the CDC, based on data from South Africa and the United Kingdom.

The FDA said authorizing the shot at 5 months instead of 6 may provide better protection sooner against Omicron.

Dr. Eric Topol, director of the Scripps Research Translational Institute in La Jolla, California, said a third shot is essential to protect against Omicron for severe disease.

“A good thing here is also the change on the timing of the booster to five months instead of six. That’s a big step for this country, which has been resistant to the data,” he added.

Countries including the United Kingdom and Israel have narrowed their window for boosters from six months to three or four following the second shot to try to fight the spread of the easily transmitted Omicron variant.

Amesh Adalja, a senior scholar at the Johns Hopkins Institute for Health Security, said he does not believe a boosters is necessary for most people since two doses of the vaccine have been effective at preventing hospitalizations and severe disease in all but older people.

“When I work at the hospital, I don’t see patients there because they lack a booster, I see patients because they lack first and second doses,” Adalja said.

Read more: Experts warn of US omicron ‘blizzard’ in weeks ahead

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UAE reports 1,796 new COVID-19 cases, no deaths

The UAE announced 1,796 new COVID-19 cases on Saturday, the official Emirates News Agency reported.

This brings the current total active cases in the UAE to 17,551 and the total number of COVID-19 cases since the start of the pandemic to 949,384, according to data from the National Emergency Crisis and Disaster Management Authority (NCEMA).

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The cases were determined out of 232,943 tests in the last 24 hours.

No deaths from the virus were recorded on Saturday, maintaining the total deaths caused by COVID-19 to 2,317 in the UAE.

At least 1,727 patients recovered in the previous 24 hours, bringing the total COVID-19 recoveries to 929,516.

On June 13, the National Emergency Crisis and Disaster Management Authority (NCEMA) announced it would strictly enforce its mask rules – with penalties for those flouting the protocol – and announced it would tighten its rules on the Al Hosn green pass system amid rising coronavirus cases across the country.

NCEMA said that it has recently “monitored some behaviors that have become a danger to society and public health,” referring to people not adhering to COVID-19 precautionary and preventative measures and how it has “negatively” impacted recovery efforts.

“Negligence and recklessness in following precautionary measures, and failure in the societal role in maintaining public health and acquired immunity, has resulted in a rise in the number of infections and new waves of the virus,” the authority spokesman said in the briefing.

The authority reaffirmed the need to wear masks in closed public spaces, reiterating that it was mandatory and that not adhering to this rule would result in a fine of up to $816 (AED 3,000).

According to the World Health Organization, more than 4.1 million cases were reported globally in the last week.

It added, however, that the worldwide number of deaths remained relatively similar to the week before, at about 8,500, noting that COVID-related deaths increased in three regions: the Middle East, Southeast Asia and the Americas.

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Omicron-specific COVID-19 vaccines could increase protection as boosters: EMA

Coronavirus vaccines tweaked to include the omicron variant strain can improve protection when used as a booster, the European Medicines Agency and other global health regulators said on Friday.
Following a meeting on Thursday, the EMA said global regulators had agreed on key principles for updating COVID-19 shots to respond to emerging variants.
While the existing coronavirus vaccines continue to provide good protection against hospitalization and death, the group said, vaccine effectiveness has taken a hit as the virus has evolved.
For more coronavirus news, visit our dedicated page.
As such, an omicron-specific or bivalent booster – meaning a vaccine that includes both the new strain and the original coronavirus strain – could “increase and extend” protection, a statement from the EMA said.
The statement refers specifically to the mRNA vaccines. Both Pfizer Inc and Moderna Inc have been testing retooled versions of their vaccines to include the omicron variant.
Vaccines which include other variants, for example the beta variant, might also be considered for use as boosters if clinical trial data demonstrate an adequate level of neutralization against omicron and other variants of concern, the statement said.
It follows guidance from the World Health Organization that omicron-specific boosters could restore protection against emerging strains of the coronavirus.
But it stops short of the position of the regulator in the United States, the Food and Drug Administration (FDA), which said on Thursday that it would seek the inclusion specifically of the newer BA.4 and BA.5 strains of omicron, currently driving a surge in new infections globally, in any new shots for use domestically.
On Tuesday, the head of a WHO advisory committee that has considered the modified shots said the group preferred BA.1-based boosters, arguing that the variant is more distinct and could generate a broader response than the more recently circulating subvariants.
Top US FDA official Peter Marks said in an interview that regulators from other countries were seriously considering using new boosters based on the BA.1 omicron variant that caused the massive surge in cases last winter, because those shots can be available sooner than the BA.4/5 based booster the United States plans to use.
The EMA said it would provide more details in coming days.
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Russia scraps remaining COVID-19 restrictions

Russia said on Friday it was ending all restrictions to combat the spread of COVID-19, including the requirement to wear masks, citing a steady decline in deaths from the virus.
However, it did not rule out re-introducing restrictive measures if the situation deteriorates.
Consumer watchdog Rospotrebnadzor said it was “suspending previously introduced restrictions, including the mask regime, a ban on public catering at night, and a number of other measures.”
For more coronavirus news, visit our dedicated page.
It said the dynamics of the virus were consistent with global trends and 93 percent of confirmed cases were mild or asymptomatic.
Since the start of the pandemic in Russia in April 2020, over 800,000 people have died from coronavirus or causes related to COVID-19, Reuters calculations show, with the country recording over 18 million infections.
Russia was quick to develop and launch its Sputnik V vaccine when the pandemic struck but take-up was slow, with many Russians citing distrust of the authorities and fear of new medical products. About 52 percent of the population has been fully vaccinated.
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