US Authorizes Pfizer-BioNTech Vaccine For 12-15 Year Olds

A health worker shows a vial of the Pfizer-BioNTech vaccine against COVID-19 at the Pascual Guerrero Olympic stadium, in Cali, Colombia, on April 26, 2021.
Luis ROBAYO / AFP

 

 

The US Food and Drug Administration (FDA) on Monday authorized the use of the Pfizer-BioNTech COVID-19 vaccine for children aged 12 to 15 years old.

“This is a promising development in our fight against the virus,” said President Joe Biden.

“If you are a parent who wants to protect your child, or a teenager who is interested in getting vaccinated, today’s decision is a step closer to that goal.”

The FDA previously granted an emergency use authorization for the Pfizer-BioNTech vaccine to individuals aged 16 and older.

“Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the Covid-19 pandemic,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.

The FDA said some 1.5 million Covid-19 cases in individuals aged 11 to 17 years old have been reported to the US Centers for Disease Control and Prevention between March 1, 2020 and April 30, 2021.

The course of the disease is generally milder in children but they can pass it on to older, more vulnerable adults.

Pfizer and its partner BioNTech said in March that their two-dose vaccine regimen was shown to be safe and highly effective in a trial of 2,260 12 to 15 year olds.

Biden last week stressed the importance of expanding vaccinations to 12 to 15 year olds and said the authorities were “ready to move immediately” once the authorization came through.

Some 20,000 pharmacies around the country were ready to begin to vaccinate adolescents, he said, and doses will also be shipped to pediatricians.

Covid-19 vaccines from Moderna and Johnson & Johnson have also received emergency use authorizations from the FDA but only for individuals over the age of 18.

Acting FDA commissioner Janet Woodcock described Monday’s move as a “significant step in the fight against the Covid-19 pandemic.”

“Today’s action allows for a younger population to be protected from Covid-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” Woodcock said in a statement.

“Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our Covid-19 vaccine emergency use authorizations,” she added.

Rwanda First African Nation To Get Pfizer-BioNTech Vaccine

Dutch Ambassador to Rwanda Matthijs Clemens Wolters (C) and the UN Representative to Rwanda Fodey Ndiaye (R) wave to the KLM pilots on the arrival of the first batch of 102,960 doses of Pfizer-BioNTech Covid-19 coronavirus vaccines at the Kigali International Airport in Kigali, Rwanda, on March 3, 2021. PHOTO: AFP

 

Rwanda on Wednesday became the first African country to receive the Pfizer-BioNTech coronavirus vaccine, with around 100,000 doses delivered in what the pharmaceutical giant hailed as a “milestone” for the continent.

The East African country received nearly 103,000 doses of the vaccine at the capital Kigali through the UN-led Covax initiative, which aims to provide equitable access to Covid-19 jabs for poorer countries.

Pfizer said the first shipment to Africa of its vaccine represented “an important milestone for the region, for Rwanda, and for the global health partners working tirelessly to fight this pandemic”.

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“Our goal is to make vaccines accessible worldwide and today’s delivery to Rwanda is a great step forward,” said Janine Small, Pfizer Global President for Emerging Markets, in a statement.

Rwanda’s Minister of Health Daniel Ngamije (R), The United Nations (UN) Country Representative Fodey Ndiaye (2nd R) and the European Union (EU) Ambassador to Rwanda Nicola Bellomo (3rd R) perform a sign of solidarity on the arrival of the first batch of 240000 doses of Oxford/AstraZeneca, at the Kigali International Airport in Kigali, Rwanda, on March 3, 2021. PHOTO: AFP

 

An official at Rwanda’s health ministry told AFP the vaccines — which must be kept at ultra-low temperatures — were “immediately transported to cold room freezers” upon arrival at Kigali aboard on a KLM flight at around 2015 local time (1815 GMT).

Earlier in the day, Rwanda took separate possession of 240,000 doses of the AstraZeneca jab, its first delivery under the Covax facility.

The health ministry said the collective 340,000 doses would be dispatched Thursday from a biomedical warehouse in Kigali to district hospitals and onward to hundreds of health centres dotted across Rwanda.

Vaccinations will begin Friday, with the country of 12 million planning to inoculate 30 percent of its population this year, and 60 percent by the end of 2022.

The ministry said the vaccine shipment should protect about 171,500 frontline personnel, as well as other priority citizens such as those over 65 or with underlying health conditions.

“We will immediately roll out our prepared vaccination plan, which will see target risk groups across Rwanda receive their first of two vaccine doses,” Health Minister Daniel Ngamije said in a statement.

In February, Rwanda became the first country in East Africa to begin vaccinating against the disease, targeting high-risk groups such as healthcare workers after acquiring around 1,000 doses of the Moderna jab.

Rwanda has carried out more than a million coronavirus tests and detected just over 19,100 cases. As of Wednesday, 265 people had lost their lives to the disease.

It imposed some of the strictest anti-coronavirus measures on the continent, including one of Africa’s first total shutdowns in March 2020. It put capital Kigali back under a full lockdown in January after a surge in cases.

Pfizer-BioNTech’s vaccine is based on different technology to AstraZeneca’s, and is expected to be much more effective in protecting against the onset of Covid-19 when transmitted through the South African variant.

AFP