Pfizer Says COVID-19 Vaccine Safe and Effective for Adolescents in Trial

CHICAGO (Reuters) – Pfizer PFE.N and BioNTech BNTX.O The COVID-19 vaccine is safe, effective and produces robust antibody responses in children 12 to 15 years old, the companies said on Wednesday, paving the way for them to gain US and EU approval to use the vaccine in this age group in a few weeks.

Data from a clinical trial, which puts the ball ahead of other Western vaccine developers in the quest to protect children, will likely allow its use in this group before the next school year, Pfizer chief executive said, Albert Bourla, in a press release.

One of the big questions drugmakers are trying to answer is whether COVID-19 vaccines work and are safe to use in children. Immunizing children and young people is seen as a crucial step in achieving “herd immunity” and taming the pandemic, which has killed more than 2.9 million people and infected 128.3 million.

“I think if we’re going to get over the pandemic… we really, really need to immunize children,” said Dr. Asuncion Mejias, pediatrician at Nationwide Children’s Hospital in Columbus, Ohio.

Young people are less likely to have serious illness and more likely to have an asymptomatic infection, which allows them to unintentionally pass COVID-19 to others.

“The asymptomatic spread is what worries you the most,” said Onisis Stefas, chief pharmacy officer at New York City Hospital System Northwell Health. “These are the people most likely to spread.”

The two-dose Pfizer / BioNTech vaccine is already cleared for use in people as young as 16 years old. The new study offers the first evidence of its effectiveness in school-aged adolescents.

In the trial of 2,260 adolescents aged 12 to 15, there were 18 cases of COVID-19 in the group who received a placebo and none among those who received the actual vaccine, resulting in a 100% effectiveness in preventing the disease, the companies said in a statement.

The vaccine was well tolerated, with side effects similar to those seen in participants aged 16 to 25 in the adult trial. The companies did not list the side effects of the latest version. In the adult trial, side effects were generally mild to moderate and included pain at the injection site, headache, fever, and fatigue.

The companies also studied a subset of adolescents to measure the level of virus neutralizing antibodies generated one month after the second dose and found it to be comparable to that of participants aged 16 to 25 in the pivotal trial in adults.

Bourla said Pfizer plans to seek expanded emergency clearance from the United States Food and Drug Administration “in the coming weeks and … (from) other regulators around the world, in the hope of start vaccinating this age group before the next one starts. school year.”

Shortly after the data was released, Israel, which is the world leader in immunization deployment, said it would start administering the vaccine to adolescents if the FDA gave it the green light.

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Scientists praised the news, which has not been published in a medical journal or peer reviewed, but said more data is needed.

Vaccinating the youngest will be important to achieve herd immunity, said Dr Peter English, retired communicable disease consultant and former chair of the British Medical Association’s public health medicine committee.

Last week, companies administered the first doses of the vaccine in a series of trials testing the vaccine in young children, including those aged 6 months.

Rivals are also testing their shots on younger people.

A trial by Moderna Inc testing its COVID-19 vaccine in children aged six months to under 12 was launched this month. Johnson & Johnson, which recently got approval for its vaccine in adults, has yet to start a planned trial here in children.

AstraZeneca in December withdrew children from an intermediate to late-stage trial of its COVID-19 vaccine in Britain.

The British drugmaker’s vaccine has been linked this year to a very rare form of blood clotting in the brain, which has prompted some European countries to stop its use in young adults, although the cause of the disease remains unclear .

Dr Anthony Fauci, an American specialist in infectious diseases, spoke in January of the prospect of a vaccination campaign for children in the United States in late spring or early summer.