US FDA authorizes first COVID-19 shot for young kids

In this May 14, 2021, file photo, Colin Sweeney, 12, gets a shot of the Pfizer COVID-19 vaccine as his mother Nicole pats his shoulder at the First Baptist Church of Pasadena in Pasadena, Calif. (MARCIO JOSE SANCHEZ / AP)

ROME / OTTAWA / – The US Food and Drug Administration on Friday authorized the Pfizer Inc and BioNTech SE coronavirus vaccine for children aged 5 to 11 years, making it the first COVID-19 shot for young children in the United States.

The shot will not be immediately available to the age group. The US Centers for Disease Control and Prevention still needs to advise on how the shot should be administered, which will be decided after a group of outside advisers discuss the plan on Tuesday.

The FDA authorized a 10-microgram dose of Pfizer's vaccine in young children, lower than the 30 micrograms in the original vaccine for those age 12 and older

Pfizer said it will begin shipping pediatric vials of the vaccine on Saturday to pharmacies, pediatricians' offices and other places where the shots may be administered.

The FDA decision is expected to make the vaccine available to 28 million American children, many of whom are back in school for in-person learning.

It comes after a panel of advisers to the regulator voted overwhelmingly to recommend the authorization on Tuesday.

Only a few other countries, including China, Cuba and the United Arab Emirates, have so far cleared COVID-19 vaccines for children in this age group and younger.

The FDA authorized a 10-microgram dose of Pfizer's vaccine in young children, lower than the 30 micrograms in the original vaccine for those age 12 and older.

ALSO READ: India expert panel recommends Covaxin for kids aged 2 & above

Advisers on the FDA panel said a lower dose could help mitigate some of the rare side effects after paying close attention to the rate of heart inflammation, or myocarditis, that has been linked to both Pfizer and Moderna vaccines, especially in young men.

The regulator said on Friday that known and potential benefits of the Pfizer vaccine in individuals aged between 5 and 11 outweigh the risks.

For the pediatric shots, the FDA has authorized a new version of the vaccine, which uses a new buffer and allows them to be stored in refrigerators for up to 10 weeks.

Canada

A Canadian decision on whether to approve Pfizer Inc's COVID-19 vaccine for those aged 5 to 11 will not come before mid- to end-November, a senior official said on Friday.

"I think we're still at least a few weeks away from a final decision … we've received some additional information just this past week that we're looking through," Supriya Sharma, the federal health ministry's chief medical adviser, told a briefing.

Denmark

Denmark, which has one of the highest vaccination rates in the world, will more than double its testing capacity after the number of virus infections has jumped in recent weeks.

Denmark will increase so-called PCR tests to about 150,000 a day from currently 100,000 and will also re-introduce private quick-test facilities, which will be able handle about 100,000 tests daily, health authorities said in a statement on Friday.

G20

Finance and health ministers from the world's 20 biggest economies (G20) said on Friday they would take steps to ensure 70 percent of the world's population is vaccinated against COVID-19 by mid-2022 and created a task force to fight future pandemics.

They could not reach agreement on a separate financing facility proposed by the United States and Indonesia, but said the task force would explore options for mobilzing funds to boost pandemic preparedness, prevention and response.

"To help advance toward the global goals of vaccinating at least 40 percent of the population in all countries by the end of 2021 and 70 percent by mid-2022 … we will take steps to help boost the supply of vaccines and essential medical products and inputs in developing countries and remove relevant supply and financing constraints," the G20 ministers said in a statement.

The ministers said they were setting up the new body because the COVID-19 pandemic had exposed significant shortcomings in the world’s ability to coordinate its response.

Moderna

Moderna Inc on Friday announced a pact with the GAVI vaccine alliance to supply a further 56.5 million doses of its COVID-19 vaccine in the second quarter of next year to low- and middle-income countries.

The vaccine maker said the doses will be in addition to an earlier commitment to supply 60 million doses in the second quarter of 2022 to GAVI, which co-leads the COVAX facility for equitable distribution of COVID-19 shots around the world.

The COVAX facility, backed by the World Health Organization and GAVI, has delivered some 400 million COVID-19 vaccine doses to more than 140 low- and middle-income countries, but several countries run the risk of failing to meet WHO's target of 40 percent vaccination coverage by year-end. read more

Moderna said the doses will be offered at a low price and GAVI continues to retain the option to procure 233 million additional doses in 2022, for a potential total of 500 million doses between this year and next.

A woman, wearing a protective face mask, reads a book at Kievskaya metro station amid the outbreak of the COVID-19 pandemic in Moscow on Oct 28, 2021. (DIMITAR DILKOFF / AFP)

Russia

Russia suffered its deadliest September since World War II, according to figures published Friday, even before the peak of its current wave of the COVID-19 pandemic forced authorities to order non-working days for the first week of November. 

There were 44,265 deaths associated with the virus last month, bringing the pandemic’s total to nearly half a million, according to Federal Statistics Service data published late Friday. That contributed to the highest number of September fatalities since the war, said Alexei Raksha, a demographer who left the agency last year after a dispute over its coronavirus numbers.

ALSO READ: Russia reports record-high daily COVID-19 infections

The situation is poised to get worse after record numbers of cases in recent weeks, leading President Vladimir Putin to declare days off nationwide. Widespread distrust of the government has hindered attempts to get people to use locally developed vaccines. 

The latest virus surge has overloaded hospitals and made several regions, including Moscow, order tougher lockdowns. 

The crisis hasn’t significantly boosted demand for vaccines, despite widespread availability of a locally-developed COVID-19 inoculation that has been shown to be effective against the virus. Just 47 percent of Russians have immunity from a vaccine or recovering from the illness, according to data from the government’s coronavirus task force.

United Kingdom

Britain will send 20 million COVID-19 vaccine doses to developing countries by the end of this year, in what Prime Minister Boris Johnson will tell other world leaders is a much needed step to speed up the post-pandemic economic recovery.

Britain said in a statement it had delivered 10 million doses of the Oxford-AstraZeneca vaccine to the COVAX vaccine-sharing facility, with 10 million more to be delivered in the coming weeks, taking the total to 30.6 million in 2021.

In 2022, Britain will donate at least 20 million more Oxford-AstraZeneca doses and also donate all the 20 million Janssen doses ordered by the government to the COVAX facility, backed by the World Health Organization and the GAVI vaccine alliance.

"Like a waking giant, the world economy is stirring back to life. But the pace of recovery will depend on how quickly we can overcome COVID," Johnson will tell G20 leaders, according to his Downing Street office.

"Our first priority as the G20 must be to press ahead with the rapid, equitable and global distribution of vaccines."

United States

Eleven US states with Republican governors sued the Biden administration on Friday seeking to block a COVID-19 vaccine mandate for federal contractors, arguing it is unconstitutional and violates federal procurement law.

Saying they were necessary to fight COVID-19, President Joe Biden issued a pair of executive orders on Sept 9 requiring all executive branch federal employees and federal contractors be vaccinated. 

A joint lawsuit was filed in the US District Court for the Eastern District Of Missouri by 10 states, Arkansas, Alaska, Missouri, Iowa, Montana, Nebraska, New Hampshire, North Dakota, South Dakota and Wyoming. Texas filed a separate suit on the same issue, and Florida filed one on Thursday.

The lawsuits on Friday described the mandate as "sweeping in its scope" and "unconstitutional and unlawful," citing a constitutional amendment on state powers and federal laws on government procurement.

The White House set a Dec 8 deadline for employees of federal contractors to be vaccinated. However, it has signaled contractors have flexibility in enforcing that deadline.