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

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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

Trump, moving to show strength, aims for Monday release

BETHESDA, Md. (AP) — President Donald Trump hoped for a Monday discharge from the military hospital where he is being treated for COVID-19, a day after he briefly ventured out while contagious to salute cheering supporters by motorcade — an outing that disregarded precautions meant to contain the virus that has killed more than 209,000 Americans.

The scale of the outbreak within the White House itself was still being uncovered as press secretary Kayleigh McEnany announced she tested positive for the virus Monday morning and was entering quarantine. Trump’s doctors have not released an update on his condition since Sunday morning.

White House officials said Trump was anxious to be released after three nights at Walter Reed National Military Medical Center, where doctors revealed on Sunday that his blood oxygen level had dropped suddenly twice in recent days and that they gave him a steroid typically only recommended for the very sick. Still, the doctors said Trump’s health was improving and he could be discharged as early as Monday to continue the remainder of his treatment at the White House.

Trump “is ready to get back to a normal work schedule” and was optimistic about a Monday release, White House chief of staff Mark Meadows told Fox News. He said a determination would be made after further evaluation by his medical team later Monday.

Less than one month before Election Day, Trump was eager to project strength despite his illness. The still-infectious president surprised supporters who had gathered outside the hospital, riding by Sunday in a black SUV with the windows rolled up. Secret Service agents inside the vehicle could be seen in masks and other protective gear.

The move capped a weekend of contradictions that fueled confusion about Trump’s health, which has imperiled the leadership of the U.S. government and upended the final stages of the presidential campaign. While Trump’s physician offered a rosy prognosis on his condition, his briefings lacked basic information, including the findings of lung scans, or were quickly muddled by more serious assessments of the president’s health by other officials.

In a short video released by the White House on Sunday, Trump insisted he understood the gravity of the moment. But his actions moments later, by leaving the hospital and sitting inside the SUV with others, suggested otherwise.

McEnany spoke briefly with reporters Sunday evening without wearing a mask, but said that no members of the White House press corps spent enough time around her to be considered close contacts.

According to the Centers for Disease Control and Prevention, the best evidence is that people with mild to moderate COVID-19 aren’t contagious about 10 days after symptom onset. People with more severe disease likely are contagious no longer than 20 days after symptom onset, according to those guidelines. That means isolation — whether in the hospital or at home — is supposed to last for at least 10 days.

Joe Biden’s campaign, meanwhile, said the Democratic presidential nominee again tested negative for coronavirus