Pfizer says 3 COVID-19 shots protect children under five |  CBC News

Pfizer says 3 COVID-19 shots protect children under five | CBC News

The companies announced Monday that three doses of Pfizer-BioNTech’s COVID-19 vaccine provide strong protection for children under five. Pfizer plans to submit the data to US regulators later this week in a move toward allowing young children to get the shots.

The news comes after months of anxious waiting by desperate parents to get their children, toddlers and preschoolers vaccinated, especially with the number of US COVID-19 cases on the rise again. 18 million children under the age of five are the only group in the United States not yet eligible for the coronavirus vaccination.

Health Canada has not yet approved COVID-19 mRNA vaccines for children under the age of five.

Pfizer told CBC News Monday morning that they are in discussions with Health Canada about a vaccine for children under five, but they cannot comment on timelines.

The U.S. Food and Drug Administration has begun evaluating data from Pfizer competitor Moderna, which hopes to start offering two child-sized shots by summer.

A young boy prepares to receive a dose of the Pfizer children’s vaccine at Scotiabank Arena in Toronto. In Canada, 41 percent of the population between the ages of 5 and 11 are considered fully vaccinated. (Mike Cole/CBC)

Pfizer had a more difficult time figuring out its approach. It aims to give children under five years of age one-tenth the amount that adults would receive – a lower dose than for children aged 5 to 12 years. However, the company discovered during its trial that two doses of that dose did not look good. Strong enough for preschoolers. So the researchers gave a third dose to more than 1,600 young adults — from six months to four years old — during a winter wave of the Omicron variant.

In a media statement, Pfizer and partner BioNTech said the extra shot did the trick, raising children’s virus-fighting antibody levels enough to meet Food and Drug Administration standards for emergency use of the vaccine without any safety issues.

The companies said preliminary data suggested the three-dose series is 80 percent effective in preventing symptoms of COVID-19, but cautioned that the calculation is based on only 10 cases diagnosed among study participants by the end of April. Study rules state that at least 21 cases are needed to formally determine efficacy, and Pfizer has promised an update once more data is available.

The companies have already submitted data on the first two doses to the Food and Drug Administration, and BioNTech CEO Dr. Ugur Şahin said the final phase three data will be submitted this week.

“The study indicates that a low dose of 3 micrograms of our vaccine, carefully selected based on tolerability data, provides young children with a high level of protection against recent COVID-19 strains,” he said in a statement.

Regulatory approvals still required

What’s Next? The FDA’s head of vaccines, Dr. Peter Marks, pledged that the agency would “move quickly without sacrificing our standards” in evaluating dose sizes for children under five from both Pfizer and Moderna.

The agency has set tentative dates next month for its scientific advisors to publicly discuss the data from each company.

Katrina Taormina pulls the Pfizer-BioNTech COVID-19 vaccine into a syringe at Lyman High School, Tuesday, July 27, 2021, in New York. Pfizer’s competitor Moderna is striving to be the first to vaccinate young children. (Mark Lenehan/The Associated Press)

Moderna strives to be the first to vaccinate young children. It provided data to the US Food and Drug Administration that young children develop high levels of anti-virus antibodies after two injections containing a quarter of the dose given to adults. The Moderna study found efficacy against symptomatic COVID-19 to be 40 to 50 percent during an omicron increase, just like adults who received only two doses of the vaccine.

Complicating Moderna’s progress, the Food and Drug Administration has so far allowed its vaccine to be used only for adults.

Last month, the company told CBC News that it hopes to complete an application for regulatory approval for a COVID-19 vaccine for children aged five and under soon.

The FDA is expected to review Moderna’s data on both the younger age group and its study of adolescents and elementary-aged children. Health Canada approved Moderna footage of children aged 6-11 in March. Last fall, Pfizer’s shot expanded to include children ages 5 to 11.

While COVID-19 is generally not as dangerous to young adults as adults, some children get very sick or even die. The Omicron variant hit children particularly hard, with those under five years old being hospitalized at higher rates than at the peak of the previous delta wave.

It is not clear how much demand to vaccinate young children will be. Pfizer shots were opened to children ages 5 to 11 in November, but only about 30 percent of that age group got the first two recommended doses. In Canada, 41 percent of the population between 5 and 11 years old is considered fully vaccinated.

Last week, US health authorities said primary-aged children should get a booster dose just as anyone 12 years of age or older is supposed to get, to get the best protection against the latest variants of the coronavirus.

2022-05-23 18:26:11

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