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4th shots were to start Sunday but may be delayed, scrapped

4th COVID vaccine dose clinical trial delayed after key panel holds up approval

Helsinki Committee authorizing clinical trials yet to sign off on test-run of extra booster for 100 volunteers for unknown reason, even as Health Ministry okays shot for elderly

A healthcare worker prepares a vaccine in Safed, northern Israel, November 29, 2021. (David Cohen/Flash90)
A healthcare worker prepares a vaccine in Safed, northern Israel, November 29, 2021. (David Cohen/Flash90)

A study examining the effectiveness of a fourth dose of the COVID-19 vaccine has reportedly yet to commence, even as the Health Ministry moves forward with authorizing the extra shot for those at risk.

Sheba Medical Center outside Tel Aviv was scheduled to begin its trial on 100 volunteers this week after requesting approval from the so-called Helsinki Committee, which signs off on all clinical trials in Israel, at the beginning of December.

But the panel never authorized the trial, Hebrew media reported. Reached for comment, the panel told Channel 12 it could not disclose its internal deliberations on the matter.

On Tuesday though, the Health Ministry’s expert advisory panel signed off on distributing a fourth dose to those over the age of 60 along with others at risk.

That roll-out was set to start Sunday but two days later, Channel 13 reported that the Health Ministry walked back that decision during a meeting on the matter after reviewing preliminary data suggesting that people with the new Omicron variant of COVID-19 are between 50 and 70 percent less likely to need hospitalization than those with the Delta strain.

The United Kingdom Health Security Agency findings add to emerging evidence that Omicron produces milder illness than other variants — but also spreads faster and better evades vaccines.

Israelis receive a dose of the COVID-19 vaccine at a health center in Katzrin, Golan Heights, on December 12, 2021. (Michael Giladi/Flash90)

Nachman Ash, the ministry’s director-general, has yet to approve the campaign for fourth doses and has been examining the data from Britain.

If more such data accumulates, Channel 13 reported, Ash may not back the government advisory panel’s recommendation to offer the additional booster shots at this stage and instead send the matter back for further deliberation.

A separate report from the Kan public broadcaster said Ash will likely make a decision on whether to approve the fourth vaccine doses by the middle of next week.

Israel was set to become the first country in the world to roll out a fourth dose for certain groups.

Kan said Prime Minister Naftali Bennett wants to start administering the additional booster shots as soon as possible but acknowledges Ash has the final say on the matter.

The move has been backed by many experts, although others have cautioned it may be better to wait for a new vaccine that is tailored to the Omicron variant.

Despite the data suggesting that Omicron may not be as dangerous as Delta, the government still fears a huge surge of coronavirus contagion in the coming weeks, several networks reported Thursday.

Kan quoted a senior health official as saying there were “black weeks ahead” for the country, while Channel 13 said the Health Ministry is expecting hundreds of thousands of people to be required to enter quarantine.

A Magen David Adom worker conducts a COVID-19 rapid antigen test at a testing center in Jerusalem on December 22, 2021. (Olivier Fitoussi/Flash90)

According to the latest Health Ministry statistics released Thursday night, 1,420 new COVID cases were confirmed the previous day, the highest daily tally since October. The positivity rate also trended slightly upward, reaching 1.45%, compared to 1.24% a day earlier and 0.9% a week ago.

The reproductive rate, or “R” number, also continued its gradual rise Thursday, hitting 1.34, up from 1.02 in early December. The transmission rate is based on data from 10 days earlier and any value above 1 shows that the pandemic is growing.

In line with the UK data, however, serious cases and hospitalizations continue to remain low. As of Thursday evening, there were 9,930 active COVID cases in Israel, with 123 of them hospitalized, 81 in serious condition and 38 on ventilators.

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