US to approve Pfizer for children as young as five, as India prepares to vaccinate toddlers against COVID-19

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Australia’s COVID-19 vaccination program may be taking new steps, but the youngest members of the community have yet to receive protection.

That may change soon, with the national medical regulator signaling a possible decision to make the Pfizer vaccine available to school-aged children by the end of the month.

Other countries are going faster.

American children could be vaccinated by Christmas

In the United States, 28 million children between the ages of five and 11 could start receiving vaccines within days, pending approval from federal regulators.

Pfizer plans to offer smaller doses of the vaccine to young children, which will be packaged in orange-capped vials to distinguish them from those given to people 12 years of age and older.

As with adults, the two doses would be spaced three weeks apart, with family physicians and pharmacies playing a major role in their administration.

“For the adults, they focused more on the large vaccination sites, but for the children, we really hope to prioritize doctors’ offices, so that children and parents can come to places where they feel at home. ‘comfortable,’ Washington DC pediatrician Dr. Jessica Long said.

It is estimated that more than 1.8 million children between the ages of five and 11 have been diagnosed with COVID-19 in the United States, with nearly 150 deaths.

Astrid, 6, will be vaccinated once Pfizer becomes available to children in the United States. (ABC News: Jade Macmillan)

The clinic where Dr Long works was inundated with parents who wanted to know when they can book their children for a photo.

“Children get COVID. We know they don’t get it as often or as seriously, but now that older populations are being vaccinated we are seeing more and more children getting it,” she said. declared.

“And there can be long-term side effects, some of which we don’t even know about yet.”

Musician Sandy Choi wants her children, David, nine, and Astrid, six, to receive their pictures as soon as possible.

“I hope the children can even get the vaccine before the holidays, it would be such a relief for us,†she said.

“We have family members that we haven’t seen since before the pandemic and we know that if the kids can at least get the first vaccine, there’s a very good chance we can get together.”

Sandy stands between her two children.
Sandy Choi hopes her children can get at least one injection before Christmas. (ABC News: Jade Macmillan)

Moderna vaccine could also be offered

Authorization of the Pfizer vaccine for children under 12 still has several hurdles to overcome.

A panel advising the U.S. Food and Drug Administration (FDA) voted overwhelmingly in favor of the move, arguing that the benefits outweigh any risks.

The FDA has since approved this recommendation, and the Centers for Disease Control are expected to make their own decision soon.

In the United States, Pfizer isn’t the only company pushing to vaccinate children between the ages of five and 11, with Moderna posting promising trial results before filing an official request.

A photo of Dr Long in front.  She has long blonde hair and a broad smile.
Jessica Long says vaccinating children is an important step in controlling COVID-19 – and preventing the development of new variants. (ABC News: Jade Macmillan )

Dr Long has four children of her own and is optimistic that the next stage of the deployment will make a difference.

“The more people who are vaccinated, the less likely it is that people will get sick, the less chance this virus has of mutating into something more potent as we have seen with the Delta variant and other situations. “she said.

“So I don’t know if this will be the last piece of the puzzle, but it’s definitely a very important step.”

Vaccines for young children

While Pfizer awaits the FDA’s decision to use its vaccine for children aged five to 11, the company is also testing the drug on those between the ages of two and five, as well as babies as young as six. month.

Pfizer says these results are expected “as early as the fourth quarter of 2021 or early in the first quarter of 2022”.

A little baby wrapped in a pink blanket sleeps.
Pfizer aims to submit data on the use of its vaccine in babies as young as six months by early next year. (ABC News: Som Patidar)

In India, some hospitals are already asking parents to register children as young as two for a COVID-19 vaccine.

The locally made Covaxin vaccine has been widely used as part of the vaccine rollout in India, which has so far seen 1 billion doses delivered to the arms of adults across the country.

Now, vaccine maker Bharat Biotech is seeking approval from India’s drug regulator to deliver the dose to anyone between the ages of two and 18.

As with the US approval process, there are several hurdles that must be overcome before children can begin receiving the vaccine.

More recently, the Indian government expert committee recommended emergency use of Covaxin for children.

Now India’s Drug Controller General – the equivalent of Australia’s Therapeutic Goods Administration – is on the verge of making a decision.

On Monday, the TGA classified Covaxin as a recognized vaccine in Australia “for the purpose of establishing traveler’s immunization status” for anyone 12 years of age or older.

In India, Bharat Biotech submitted data from Phase 3 trials of the drug involving children.

According to local media, data showed that the Covaxin vaccine produced a similar rate of effectiveness in children and adults – 77.8 percent.

A mother is standing, wrapped in an orange sari, holding a young child with two standing at her feet.
Children as young as two could soon receive COVID-19 vaccines in India. (Reuters: Adnan Abidi)

If the vaccine is approved for children, India’s most vulnerable young people will have access to the drug first.

In southern India, Ankura Hospital is preparing to vaccinate children in its pediatric ward.

“Our hospital is already doing adult vaccinations and preparations are underway for childhood vaccination. We are fully prepared and will start after government approval,” said pediatrician Dr Suman Kumar.

Dr Kumar said children with pre-existing heart problems, lung and kidney problems, diabetes, immune deficiency and other serious health complications are “the most vulnerable, so vaccination should start with them.”

“We have seen mortalities in previous waves and children aged 16 to 18 are as affected as adults,” he said.

Three young girls stand in a field, wearing navy blue uniforms and face masks.
Experts believe that young schoolchildren should be vaccinated after those with health complications and after 16-18 years old. (PA: Anupam Nath)

With over a billion doses administered, India has only fully immunized 30% of its eligible population, and the number of people vaccinated each day has slowed.

Bringing the kids into the deployment will use more supply.

Dr Kumar said a “huge stockpile” of Covaxin was needed before launching a mass vaccination campaign among India’s young child population.

“They are [scaling] increase their production, but the government still wants to fully immunize adults before starting mass immunization of children, â€he said.

India’s expert committee on vaccines has said that all children from the age of two will be able to access the vaccine from early 2022.

Young people between the ages of 12 and 18 are already eligible for vaccines in several countries, including Australia.

India is expected to open its program to this age group soon, and they will be able to access a needleless injection.

Another vaccine developed in India – by manufacturer Zydus Cadila – is the world’s first DNA vaccine.

It carries the genetic code for the coronavirus spike protein, which the body can then read and generate an immune response.

The vaccine, called ZyCoV-D, is given through a jet injector – sometimes called a gene gun – and uses a high-pressure flow of fluid to propel it into skin cells.

A close up of a jet injector in an arm.
The DNA vaccine is administered using a needleless injection system.(AP: Business Wire)

Vaccinate children around the world

The Covaxin vaccine was developed in India and is currently being evaluated by the World Health Organization for inclusion on the list of COVID-19 vaccines accepted worldwide.

WHO approval would see Bharat Biotech’s Covaxin vaccine join Pfizer, Moderna, AstraZeneca, Sinovac, Sinopharm, Johnson and Johnson and the Serum Institute vaccine as drugs approved for emergency use.

A young boy receives a vaccine.
In El Salvador, children as young as six can be vaccinated against COVID-19. (Reuters: José Cabezas )

China recently included children in its immunization program, with authorities approving the use of Sinopharm and Sinovac vaccines for people aged three to 17.

After the vaccines received national approval, foreign governments began to immunize children in their own countries.

Cambodia uses both Sinovac and Sinopharm injections in children six to 11 years old. Regulatory agencies in Chile and El Salvador have approved Sinovac for children as young as six years old. In Argentina, regulatory authorities have approved the Sinopharm vaccine for children as young as three years old.

Cuba has also started immunizing children as young as two, but the country has used local vaccines that have not been approved by the WHO, or have had their test data independently reviewed.

ABC / PA

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