Showing: 1 - 2 of 2 RESULTS

COVID Vaccine Update as Johnson & Johnson Trial Suffers Setback, Sanofi Aims for Mid-2021 Rollout

There are currently nearly 200 potential COVID-19 vaccine candidates in development, including 42 under clinical evaluation and 151 under pre-clinical evaluation, according to a report by the World Health Organization published on October 2.



a person wearing a costume: A lab technician wearing observing a bottle containing a reagent before performing vaccine tests at French pharmaceutical company Sanofi's laboratory in Val de Reuil in northwest France on July 10. Sanofi is hoping to get its COVID-19 vaccine candidate approved within the first half of 2021.


© Joel Saget/AFP via Getty Images
A lab technician wearing observing a bottle containing a reagent before performing vaccine tests at French pharmaceutical company Sanofi’s laboratory in Val de Reuil in northwest France on July 10. Sanofi is hoping to get its COVID-19 vaccine candidate approved within the first half of 2021.

On Monday, U.S.-based Johnson & Johnson announced a pause on all of its COVID-19 vaccine candidate clinical trials due to an “unexplained illness” in one of its study participants.

French pharmaceutical company Sanofi is hoping to have its vaccine candidate rolled out by mid-next year, according to Olivier Bogillot, its chief executive officer.

“We are in a very concrete environment at the regulatory level. We ourselves have signed a charter with various laboratories so as not to compromise on the safety of the vaccine. If the vaccine is effective and it is safe, yes, the next year, in mid-year, the French will be able to be vaccinated,” Bogillot said Tuesday.

Last week, U.S. Secretary of Health and Human Services Alex Azar said: “Pending FDA [Food and Drug Administration] authorizations, we believe we may have up to 100 million doses by the end of the year—enough to cover especially vulnerable populations—and we project having enough for every American who wants a vaccine by March to April 2021.”

The First Phase 3 Clinical Trial Of A Coronavirus Vaccine In The US Has Begun

UP NEXT

UP NEXT

Here we take a closer look at some of the latest COVID-19 vaccine developments.

France

Last month, Sanofi and U.K.-based GlaxoSmithKline (GSK) announced they has begun a clinical trial of their COVID-19 vaccine candidate, aiming to reach a phase-three trial by December.

“The companies initiated a Phase 1/2 study on September 3 with a total of 440 subjects being enrolled, and anticipate first results in early December 2020, to support the initiation of a pivotal Phase 3 study before the end of the year,” Sanofi confirmed in a statement last month.

“If these data are sufficient for licensure application, it is planned to request regulatory approval in the first half of 2021. In parallel, Sanofi and GSK are scaling up manufacturing of the antigen and adjuvant respectively with the target of producing up to one billion doses in total per year, globally.”

U.S.

Johnson & Johnson

Johnson & Johnson, whose vaccine candidate JNJ-78436735 is being developed by Belgium’s Janssen Pharmaceutical Companies, announced: “We have temporarily paused further dosing in all our COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant.

“Following our guidelines, the participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as our internal clinical and safety physicians.

“Adverse events—illnesses, accidents, etc.—even those that are

15-minute coronavirus test gets the green light for a European rollout

Dr. Vincent Carrao draws blood from a patient for the coronavirus disease (COVID-19) test at Palisades Oral Surgery, in Fort Lee, New Jersey, U.S., June 15, 2020. Picture taken June 15, 2020.

Brendan McDermid | Reuters

A test to detect Covid-19 that can be done at the point of care and gives results in 15 minutes has been given the greenlight in Europe, according to its maker Becton Dickinson.

The test should be commercially available in Europe by the end of October, the diagnostics specialist said Wednesday, as it announced its antigen test had been granted a “CE mark” in Europe, meaning it conforms with health, safety, and environmental protection standards for products sold within the region.

The new test delivers results in 15 minutes on a small, portable instrument, BD said in a statement Wednesday, adding that this is a “critical improvement in turnaround time for Covid-19 diagnostics, because it provides real-time results and enables decision-making while the patient is still onsite.”

“The addition of a truly portable, point-of-care test that can deliver results while the patient waits will be welcomed by health care providers and patients alike to help protect against additional waves of Covid-19,” Roland Goette, president of BD EMEA, remarked. 

In July, the U.S. Food and Drug Administration (FDA) granted emergency use authorization to the company’s rapid antigen test, that works by looking for proteins that can be found on or inside the Covid-19 virus.

It has been widely reported that while antigen tests can be carried out faster than molecular diagnostic tests which are conducted in laboratories, they are generally less accurate.

Becton Dickinson says that clinical studies performed at more than 20 sites across the U.S. demonstrated that the test is capable of achieving 84% sensitivity (a measure of how well it correctly identifies infections) and 100% specificity (how well it correctly identifies negative tests) but the U.S. FDA recommends that negative test results be confirmed by a molecular method to confirm the result.

BD said it is leveraging its global manufacturing network and scale to produce 8 million Covid-19 antigen tests per month by October and expects to produce 12 million tests per month by March 2021.

It is by no means alone in developing a rapid antigen test for the virus, with Roche announcing earlier in September that its own 15-minute antigen test had received the CE mark and German diagnostic test maker Qiagen also announcing earlier this month that it planned to launch a 15-minute antigen test.

In mid-September it was reported that BD was looking into reports from nursing homes that its rapid Covid-19 testing equipment was producing false positive results in some cases.

Source Article