Italy and France approve J&J’s COVID-19 vaccine, also gets WHO emergency listing approval

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Italy’s medicines agency AIFA and France’s health regulator, the Haute Autorite de Sante (HAS), said on Friday they have approved the use of the COVID-19 vaccine produced by Johnson & Johnson, following the green light from European drugs regulator (EMA) on Thursday.

The vaccine is the fourth to be endorsed for use in the European Union after vaccines from Pfizer-BioNTech,, AstraZeneca-Oxford University and Moderna, and is recommended for those over 18 years of age. It’s the first single-dose COVID-19 vaccine.

“This is the fourth vaccine to be available with the important additional advantage of a single dose and ease of administration, therefore ideal for the setting of family doctors. From mid-April, an important reality,” said AIFA’s general director Nicola Magrini in the agency’s website.

The Italian agency said it confirmed the EMA’s assessment of the vaccine’s efficacy, which reaches up to 77% 14 days after administration and 85% 28 days after administration.

“The COVID-19 Janssen vaccine can be used on people from the age of 18 … within the framework of the French vaccination strategy, including for people aged 65 and older and who might have illnesses,” the Haute Autorite de Sante (HAS) said in a statement.

HAS said the vaccine was efficient and well tolerated by patients. It will be the fourth vaccine on the French market.

The World Health Organization on Friday approved the emergency listing of Johnson & Johnson’s COVID-19 vaccine, giving its seal of approval to expedite use especially in countries with weaker regulatory agencies.

It is the third COVID-19 vaccine after the two-shot regimens of Pfizer/BioNTech and AstraZeneca to receive backing from the WHO, and the first requiring just a single injection.

The listing covers use in all countries, for roll-out of the vaccine facility COVAX and follows the European Medicines Agency (EMA) authorisation announcement on Thursday.

“Every new, safe and effective tool against COVID-19 is another step closer to controlling the pandemic,” WHO Director-General Tedros Adhanom Ghebreyesus said in a statement.

“Emergency use listing is the greenlight for a vaccine to be procured and rolled out by COVAX,” he told a news conference.

WHO is convening its strategic advisory group of immunisation experts next week to draw up recommendations on its use, he added.

“But the hope offered by these tools will not materialise unless they are made available to all people in all countries,” he said.

The WHO also welcomed the one-shot administration as facilitating vaccination logistics.

WHO senior adviser Bruce Aylward said that the Johnson & Johnson vaccine, which does not require an ultra cold chain, was “even better suited to some of the countries that are worst-hit, affected by the pandemic”.

COVAX, co-run with the Gavi vaccine alliance, has an agreement for more than 500 million doses of the J&J vaccine, Aylward said.

“What we are trying to do is work with the company to bring that forward as early as possible. And we are hoping by at least July that we have access to doses that we can be rolling out, if not even earlier.”

J&J’s chief scientist Paul Stoffels told Reuters on Thursday the company expects to produce up to 3 billion doses of the vaccine next year, after previously pledging to deliver 1 billion globally by the end of 2021.

The WHO said that, under an emergency-use listing, companies have to commit to generate further safety and efficacy data to enable full licensing.

Main Photo: The first boxes of the Johnson and Johnson COVID vaccines at the McKesson Facility in Shepherdsville, Kentucky, USA. EPA-EFE/TIMOTHY D. EASLEY / POOL

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