Pfizer starts tests on babies and young children

Pfizer said it started a clinical trial testing its Covid-19 vaccine on healthy children aged 6 months to 11 years, a crucial step in obtaining federal regulatory authorization to start vaccinating children and controlling the pandemic.

The first study participants have already taken their injections, which were developed in partnership with the German pharmaceutical company BioNTech, Pfizer of New York announced Thursday. It intends to enroll 144 children in the first phase.

For the first phase of the study, the company will identify the preferred dosage level for three age groups – between 6 months and 2 years, 2 and 5 and from 5 to 11 years. Children will start by receiving a 10 microgram dose of the vaccine before progressively moving to higher doses, Pfizer said. Participants also have the option of taking doses of 3 micrograms. The Covid vaccine for adults requires two injections that contain 30 micrograms per dose.

The researchers will then assess the safety and efficacy of the selected dose levels in the next phase of the study, with participants being selected at random to receive the vaccine or a placebo, the company said. After a six-month follow-up, children who received a placebo will have the opportunity to receive the vaccine, he said.

“Pfizer has deep experience in advancing clinical vaccine testing in children and babies and is committed to improving the health and well-being of children through carefully planned clinical tests,” the company said in a statement.

The Pfizer vaccine has already been authorized for use in the United States in Americans aged 16 and over. Clinical studies testing the vaccine in children, whose immune systems may respond differently than adults, have yet to be completed.

Vaccination of children is crucial to ending the pandemic, say public health officials and infectious disease specialists. The United States is unlikely to achieve collective immunity – or when enough people in a given community have antibodies against a specific disease – until children can be vaccinated. Children make up about 20% of the US population, according to government data.

In late January, Pfizer said it had fully enrolled the Covid-19 vaccine test in children aged 12 to 15 years. The company said on Thursday that it is “encouraged” by the data from this cohort and said it hopes to share additional details about the test “soon.”

Moderna, which also has a vaccine authorized in the United States, said on March 16 that it has started testing its vaccine on children under 12. In December, Moderna started a study testing children aged 12 to 17 years.

Johnson & Johnson plans to test its single injection vaccine on babies and even newborns, after first testing it on older children, according to The New York Times.

White House chief medical advisor, Dr. Anthony Fauci, told a House committee earlier this month that the US could start vaccinating older children against Covid-19 this fall, while elementary school children can begin to vaccinate. get your vaccinations early next year.

Pfizer’s announcement comes two days after it announced the start of an early-stage clinical trial of an experimental oral antiviral drug that could be used at the first sign of Covid infection.

Health experts say the world will still need a range of drugs and vaccines to end the pandemic, which has infected more than 30 million Americans and killed at least 545,282 in just over a year, according to data compiled by Johns University Hopkins.