Stories
Slash Boxes
Comments

SoylentNews is people

SoylentNews is powered by your submissions, so send in your scoop. Only 19 submissions in the queue.

Submission Preview

Link to Story

FDA Panel Gives Johnson & Johnson's One-shot COVID-19 Vaccine Green Light

Accepted submission by martyb at 2021-02-27 01:38:35
News

According to c|net, FDA panel gives Johnson & Johnson's one-shot COVID-19 vaccine green light [cnet.com]:

An advisory panel for the US Food and Drug Administration has recommended Johnson & Johnson's single-dose COVID-19 [cnet.com] vaccine be given the green light by the FDA. The FDA Vaccines and Related Biological Products [fda.gov] Advisory Committee unanimously voted Friday afternoon to approve the vaccine [youtube.com].

The next step will be emergency approval from the FDA itself.

[...] In early February, a week after announcing that its single-dose vaccine [cnet.com] was 66% effective overall in preventing [jnj.com] COVID-19 in a global clinical trial, Johnson & Johnson submitted an application requesting the FDA grant emergency use authorization for the vaccine [cnet.com].

It would be the third vaccine on the US market, following the FDA granting emergency use authorization for the Pfizer [cnet.com] and Moderna [cnet.com] coronavirus vaccines in December, with vaccinations beginning just days later. Those vaccines are said to be 95% and 94% effective, respectively. Unlike the Pfizer and Moderna vaccines, Johnson & Johnson's vaccine requires only a single shot [cnet.com].

Earlier this month, President Joe Biden announced that the US is buying enough doses of Pfizer and Moderna COVID-19 vaccines to cover 300 million people [cnet.com] in the country by the end of July -- though this doesn't mean everyone will be vaccinated by then.

"We've now purchased enough vaccine supply to vaccinate all Americans," Biden said [twitter.com]. Actually administering the vaccines to all Americans could take longer [cnet.com] because vaccinations are managed at a state and local level.

Here's where to get a COVID-19 shot [cnet.com], and here's how to track how many vaccines are available [cnet.com] in your state.

MIT's Technology Review adds The one-shot vaccine from Johnson & Johnson now has FDA support in the US [technologyreview.com]:

The new one-shot vaccine, called Ad26.COV2.S, was developed by Johnson & Johnson using work from Beth Israel Deaconess Medical Center in Boston. It employs a harmless viral carrier, adenovirus 26, which can enter cells but doesn’t multiply or grow. Instead, the carrier is used to drop off gene instructions that tell a person’s cells to make the distinctive coronavirus spike protein, which in turn trains the immune system to combat the pathogen.

The New York Times published a detailed graphical explanation [nytimes.com] of how the vaccine works.

Richard Nettles, vice president of US medical affairs at Janssen, a J&J subsidiary, told Congress during testimony [house.gov] on February 23 that production of the vaccine is “highly complex” and said the company was working to manufacture the shots at eight locations, including a US site in Maryland.

The manufacturing is complicated because the vaccine virus is grown in living cells before it is purified and bottled. Making a batch of virus takes two months, which is why there is no way to immediately increase supplies if timelines are missed.

[...] In late January [jnj.com], the company announced results from a 45,000-person study it carried out in the US, South Africa, and South America, in which people got either the vaccine or a placebo.

Overall, the vaccine was 66% effective in stopping covid-19, and somewhat better at stopping severe disease. In the trial, for instance, seven people died of covid-19, but all of these were in the placebo arm. Also, its effects increased with time—after a month, no one in the vaccine arm had to go to the hospital for covid-19.

[...] The J&J shot has fewer side effects than the mRNA vaccines and has also proved effective against a highly transmissible South African variant [technologyreview.com] of the virus that has accumulated numerous mutations.

The South Africa variant has alarmed researchers because it clearly decreases the effectiveness of some vaccines. A study in South Africa by AstraZeneca found its vaccine didn’t offer protection against the variant at all, causing officials to scrap a plan to distribute the shot there.


Original Submission