Pyser Testing

FDA

FDA Tells People to Throw Innova Lateral Flow Tests in the Bin

The American Food and Drug Agency (FDA) says the performance of the Innova-manufactured lateral flow test – the one in use across Britain, including in schools – has not been proven to be reliable and, for that reason, the test should either be returned to the manufacturer or thrown in the bin. The Guardian has more.

The FDA has raised significant concerns about the rapid Covid test on which the U.K. Government has based its multibillion-pound mass testing programme.

In a scathing review, the US health agency suggested the performance of the test had not been established, presenting a risk to health, and that the tests should be thrown in the bin or returned to the California-based manufacturer Innova.

In the UK, these lateral flow Innova tests form the cornerstone of Operation Moonshot, the mass-testing scheme championed by the prime minister’s former chief adviser. The idea was that the ability to deliver results within 30 minutes – without the need for processing in a laboratory – provided a cheap, pragmatic and efficient way to identify people who had caught the virus but not fallen ill. But critics have raised concerns about accuracy.

Given the tests have been offered free to millions in England, for use at home or at test centres, workplaces and schools, with the aim of detecting more cases, breaking chains of transmission and saving lives since April, the FDA announcement is particularly damning.

The US agency has not authorised the use of the Innova test in the US, although the manufacturer has submitted a request for authorisation. But when the FDA discovered the Innova test was being distributed for US use regardless, it conducted an inspection of Innova’s medical device operations between March and April 2021.

In its report, the agency accused the company of “false or misleading” estimates of the clinical performance of certain configurations of the test, saying the estimates did not accurately reflect the performance of the diagnostic devices during clinical studies.

The FDA also highlighted that the clinical study data submitted by Innova as part of its request for US authorisation was identical to data previously provided by other manufacturers in separate requests.

Worth reading in full.

Moderna Hopes Its Covid Vaccine Will Be the Second to Be Authorised for Use in American Children

Moderna has asked the U.S. Food and Drug Administration (FDA) to extend the emergency use of its Covid vaccine to American children aged 12 and over. The FDA approved the use of the Pfizer Covid vaccine in children a month ago on Thursday, and earlier this month the U.K.’s medicines regulator did the same for British children. The MailOnline has more.

When the [Moderna] vaccine was originally authorised for use by the FDA in December 2020, it was only for those aged 18 and older. 

However, recent Phase Three clinical trial data showed no children who were given the immunisation fell ill with the virus within 14 days of their second dose, while four children given the placebo later tested positive.

According to Moderna, this is “consistent with a vaccine efficacy of 100%”.

It comes exactly four weeks after Pfizer received approval from the FDA to administer its vaccine to children between ages 12 and 15. 

As of Thursday, more than seven million U.S. children between ages 12 and 17 have received at least one dose of the vaccine.

Still, only about one in three parents said they would immunise their children right away.

Although children can contract Covid and pass the disease on to others, they tend to not get very ill and make up about 0.1% of deaths.

“We are pleased to announce that we have submitted for an emergency use authorization for our Covid vaccine with the FDA for use in adolescents in the United States,” said Moderna CEO Stéphane Bancel in a statement

“We are encouraged that the Moderna Covid vaccine was highly effective at preventing Covid and SARS-CoV-2 infection in adolescents.”…

Moderna’s study included 3,732 adolescents from ages 12 to 17 enrolled at sites across the U.S….

Side effects were mild or moderate with the most common being pain at the site of injection, similar to adults in the clinical trial last year.

Other common symptoms were fatigue, headache, muscle pain and chills, but no serious side effects were reported. 

Worth reading in full.