Israeli vaccine candidate reportedly set to begin human trials next week

Shot developed by Defense Ministry’s Institute for Biological Research still far from wider phase 3 trials; Moderna says its vaccine will not be ready before US election

A nurse gives a volunteer an injection as part of a study of a possible COVID-19 vaccine, developed by the US National Institutes of Health and Moderna Inc., in Binghamton, New York, July 27, 2020. (Hans Pennink/AP)
Illustrative: A nurse gives a volunteer an injection as a study of a possible COVID-19 vaccine, developed by the National Institutes of Health and Moderna Inc., in Binghamton, New York, July 27, 2020. (Hans Pennink/AP)

A COVID-19 vaccine being developed by Israel’s national research laboratory is reportedly set to begin human trials next week.

At first, around 100 young adults will receive the vaccine developed by the Defense Ministry’s secretive Institute for Biological Research, Channel 12 reported on Thursday.

Around two months later, if the first tests are deemed a success, an additional 1,000 people, of varying ages, will receive a dose.

In the third and final phase of testing, which depends on the outcome of the first two phases and other developments, tens of thousands will be tested.

The director of the institute, Shmuel Shapira, presented the mayor of Ness Ziona with a ceremonial first batch of the experimental vaccine on Thursday.

The research institute is based in the central city. The vial of vaccine presented to the mayor was apparently not meant to be administered in the trials, but was mounted in a box with a small plaque thanking the mayor for his “true cooperation.”

In August, Defense Minister Benny Gantz said the laboratory would begin its vaccine trials in mid-October, following a visit to the institute.

Shapira told the Knesset Science and Technology Committee in August that the vaccine would be ready for human trials in October, but would not be ready for phase three testing until next year.

In June, the institute announced it had completed successful coronavirus vaccine trials on rodents.

In a paper published on the website of bioRxiv, an online repository for papers that haven’t yet been peer-reviewed, the institute said it hoped to have a finished vaccine in a year, or possibly even earlier.

In the abstract of the paper, the researchers said their vaccine, which they tested on hamsters, “results in rapid and potent induction of neutralizing antibodies against SARS-CoV-2,” the virus that causes COVID-19.

Meanwhile, in the US, the CEO of biotech firm Moderna said on Wednesday the firm won’t seek an emergency use authorization for its coronavirus vaccine before November 25, after the presidential election.

The news deals a blow to US President Donald Trump’s hopes of having an injection ready before the election, which could give his campaign a much-needed shot in the arm.

Stephane Bancel told The Financial Times: “November 25 is the time we will have enough safety data to be able to put into an EUA file that we would send to the FDA [Food and Drug Administration] — assuming that the safety data is good, i.e. a vaccine is deemed to be safe.”

Trump, whose approval has taken a hit over his handling of the COVID-19 crisis, has frequently hinted a vaccine could be ready before the November 3 vote.

This has raised concern among experts that his administration may attempt to interfere with the regulatory process for political reasons.

Another vaccine candidate is being developed by Pfizer, whose CEO Albert Bourla has taken the position that his company may have a clear answer about whether its shot works by October.

Most experts are skeptical of the claim, believing that the ongoing trials will not have sufficient statistical data to prove the drug’s safety and effectiveness by that time.

Speaking to the Washington Post on Tuesday, Bourla denied he was attempting to curry favor with the president by making his October claim.

“For me, the election day is an artificial day. The end of October is an artificial day. This is how we operate. If we can bring it earlier, we will,” he said.

On Thursday he told employees that he was disappointed that its work was politicized during this week’s presidential debate and tried to reassure US staff that the company won’t bend to pressure to move more quickly.

Bourla said that the company is “moving at the speed of science,” rather than under any political timing, according to a staff letter obtained by The Associated Press.

“The only pressure we feel — and it weighs heavy — are the billions of people, millions of businesses and hundreds of government officials that are depending on us,” he wrote.

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