Saturday, December 4, 2021

FDA approves new influenza vaccine

Written by By Ali Nabulsi, CNN

The Food and Drug Administration (FDA) has given approval to a new vaccine that will protect vulnerable populations such as those with compromised immune systems — including infants and people with HIV.

The Booster Shot — made by Cronos Group, the parent company of Cronos California — is called the KBG-VAXX vaccine and aims to protect certain people from flulike illness.

It will be available in five states, including California.

Flu sufferers, pregnant women and people with weakened immune systems will be the prime candidates for the Booster Shot, according to the Cronos Group

Cronos Group is the leading medical-cannabis company in the world.

‘Packaging in dispute’

The FDA says Cronos’ single-dose dose will protect people who are immunocompromised, such as those with HIV, cancer, stroke or tuberculosis.

Infection with the H7N9 bird flu strain, which killed more than 150 people, was recently traced to avian pox vaccines given to poultry.

On Thursday, Cronos filed an application to the FDA for a drug labeling change based on the new vaccine.

But the vaccine doesn’t offer protection against the H1N1 flu, which can be life-threatening. And Cronos’ filing has drawn criticism.

The data “doesn’t change the way the FDA should view this piece of legislation,” John August, president of the Drug Information Association and chief medical officer at CVS Health, told CNN.

The US Food and Drug Administration initially approved Cronos’ Booster Shot after a 2007 clinical trial (the only study of its kind in the world), however, not all of the evidence involved was considered “credible.”

As a result, the FDA issued an advisory to the company on September 19, 2016, telling them to change some of the design and testing details of the vaccine.

“(The recall application) was filed in late October 2017,” said August. The FDA approved the request for the return of files related to the old data.

FDA’s approval of this latest version of the vaccine was based on a clinical trial performed in Australia, where the initial study was conducted. This study showed “that flu vaccines could pass FDA efficacy measures,” a statement from the FDA says.

In South Korea, the Booster Shot is already being used to treat patients with HIV infection. The country was the first in the world to approve the vaccine.

Cronos says that the new vaccine was developed to target groups already at risk of having influenza because of their health condition.

Virtually no one — except for pregnant women and people with health conditions — gets a flu shot every year.

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