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Enugu State Government says it recorded 100 per cent success in its just-concluded polio vaccination, which targeted 1,014,953 children aged between 0 and 5 years.

The News Agency of Nigeria (NAN) recalls that the state embarked on a five-day vaccination programme to prevent polio after receiving 1,306,700 doses of the new oral polio vaccines from National Primary Health Care Development Agency and its health partners.

Dr George Ugwu, Executive Secretary, Enugu State Primary Health Care Development Agency (ENS-PHCDA), told NAN on Thursday in Enugu that the 2,834 vaccinating teams and their field supervisors worked with “serious dedication”.

Ugwu said that by the fourth day, the vaccination teams were able to hit the number of the targeted population.

According to him, the state even surpassed the projected target of children we set for the exercise, which is 20 per cent of the entire state population.

The ENS-PHCDA boss said that the overwhelming success, which international health partners that supervised the exercise attested to, was due to the commitment of Gov. Ifeanyi Ugwuanyi to the exercise.

Asked on what was done differently, Ugwu said that the Agency did massive mobilisation of community leaders, town union president-generals and religious leaders; while it sustained media sensitisation before and during the exercise.

“This wide sensitisation created the demand for the polio vaccine even before our vaccinating teams got to the children and also helped in countering any perceived unfounded misinformation concerning the polio vaccines.

“Two, we also paid transport stipend directly to the vaccinating teams especially those at the ward levels and same provision for their supervisors as well as other incentives given by the Gov. Ugwuanyi to ensure the success.

“The governor also improved on the storage capacity and logistics of moving the vaccines with right packs and temperature to the various Primary Health Care (PHC) centres and ward aggregation points leading to quick and seamless distribution.

“Again, we ensured accountability from our supervisors as the Agency kept them on their toes and ensured daily review of vaccination activities in each council areas during the exercise,” he said.

Ugwu noted to ensure no child was left out, the state added two extra days (mop-up days), to enable the vaccination teams to keep searching all the nook and crannies.

“We have to send another text message to the community and religious leaders across the state, appealing to them to use traditional means to get across to their people to ensure that no child is left out and they did,” he said.

The ENS-PHCDA boss lauded Gov. Ifeanyi Ugwuanyi for supporting the agency tremendously for the exercise, and mobilizing both professionals and logistics, to ensure the huge success recorded in the exercise.

“Our health-loving governor, Chief Ifeanyi Ugwuanyi, has supported the agency to ensure that no child is left out, notwithstanding the remoteness and the extra cost to locate the child,” he said.

He also appreciated the health partners of the state for providing the support and guidelines followed by the Agency for resounding success.

NAN reports that the statewide polio vaccination took place between Oct. 6 and Oct. 10; while the two mop-up days took place between Oct. 12 and Oct 13.
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The Pharmaceutical Council of Nigeria, PCN, has begun trial of three pharmacists accused of falling short of the conduct and ethics of the pharmacy profession.

The trio, said to be pharmaceutical representatives of drugs manufacturing companies, allegedly failed to remit large amounts of money realised from drugs released to them for sale.

A disciplinary committee of PCN arraigned the accused shortly after inauguration on Friday evening at the council’s headquarters in Abuja.

Speaking to journalists on the development, the Chairman of Governing Council of Pharmacists Council of Nigeria, Prof. Ahmed Mora, warned pharmacists in Nigeria against unwholesome practices, reiterating that anyone found wanting would not be spared from facing the long arm of the law, no matter his position in the society.

Mora, who did not provide the names of the accused, explained that the tribunal was not a criminal one but bothered on professional misconduct, adding that the consequences of the offence could be delisting of offenders from pharmaceutical business.

“A tribunal has been inaugurated and has started hearing. I assure you that before the end of the year, we are going to sit again to make a pronouncement on the sentence on one case and continue with the trial of others.  We do not expect pharmacists to fall short of code of conduct and ethics of the profession,” he said.

According to him, the cases being handled by the tribunal are “those of fraud, of some pharmacists not remitting amounts of drugs given to them   to sell or to market in large amounts after periodic requests by those who own those premises ( pharmaceutical manufacturers and wholesalers).

“These premises have what we call pharmaceutical representatives or medical representatives. Usually, they are given large consignment of pharmaceutical products to market.”

“So, in all these cases, it appeared that these drugs have been sold but they have not remitted the money to the manufacturers or the wholesalers, prompting petitions to PCN.’’

Mora, who also explained that the tribunal was unable to sit for six years, explained further that the action was not deliberate.

He warned: “The inability of the tribunal to sit for six years was not deliberate,it was because there was no governing council in place.

“Now with the governing council in place, we now have the disciplinary committee of the Pharmacists Council of Nigeria and there is no limitations on the number of times that it sits. It depends on the cases referred to it from the investigative panel.
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FILE PHOTO: FILE PHOTO: The Merck logo is seen at a gate to the Merck & Co campus in Rahway, New Jersey

The plan to roll out Merck & Co’s promising antiviral pill to treat COVID-19 risks repeating the inequities of vaccine distribution, potentially leaving the nations with the greatest need once again at the back of the line, international health groups say.

For example, only about 5% of Africa’s population is immunized, creating an urgent need for therapeutics that could keep people out of hospitals. That compares with more than a 70% inoculation rate in most wealthy nations.

Merck on Oct 11 applied for U.S. emergency clearance of the first pill for COVID-19 after it cut hospitalizations and deaths by 50% in a large clinical trial. The medicine, made with Ridgeback Biotherapeutics, could gain authorization as soon as December.

The U.S. drugmaker has taken the unusual pandemic step of licensing several generics of its antiviral molnupiravir before its branded version was even authorized for marketing.

But international health officials said even that is not enough for the medicine to reach many in low- and middle-income countries in large enough numbers, while noting shortcomings and red tape among global organizations that could further slow distribution.

Merck this year plans to produce 10 million treatment courses of the pill, which is taken twice a day for five days, and another 20 million next year.

In addition, its licensing deals with eight Indian drugmakers will allow cheaper generic versions for 109 low- and middle-income countries including in Africa, a move international groups acknowledge is a positive concession.

But as wealthy nations secure molnupiravir supply deals – the United States has already locked up 1.7 million courses with an option for 3.5 million more by January of 2023 at about $700 per course – concerns grow over who might be left out.


Merck said it has worked on the technology transfer needed to start generic manufacturing, in contrast to vaccine makers who continue to resist calls to waive patents or allow for generic versions to boost supplies.

But a recent report prepared for the United Nations’ Access to COVID-19 Tools Accelerator program tasked with buying COVID-19 therapeutics for poor countries cited concerns that U.N. agencies were not moving quickly enough to secure adequate volumes of potential new treatments ahead of time, including Merck’s drug.

Medicines Patent Pool (MPP), a United Nations-backed public health organization, has 24 companies signed up and willing to make the drug if Merck agrees to expand the licenses.

“If you’re not in the license, you’re relying on Merck, and it looks to us that that could mean a potential supply shortfall as well as overpricing,” said Peter Maybarduk of Public Citizen, who sits on the MPP governance board. He suggested that could lead to wealthy countries outbidding poor nations for the medicine.

It is unclear how many generic pills will be available or when. The licensed Indian manufacturers including Aurobindo Pharma, Cipla Ltd, Dr. Reddy’s Labs , Emcure Pharmaceuticals, Hetero Labs, Sun Pharmaceuticals, and Torrent Pharmaceuticals declined to provide details on production plans.

In addition, manufacturing for low-income countries in many nations also requires World Health Organization (WHO) approval, a regulatory process that typically takes months.

Merck said it is committed to providing timely access to its drug globally with plans for tiered pricing aligned with a country’s ability to pay. A spokesperson confirmed it is in discussions about expanding licenses for generic molnupiravir “to build sufficient global supply of quality-assured product to meet orders globally.”

But middle-income countries will be hard pressed to negotiate against the richest nations, another MPP official said.

The governments of Australia, South Korea, Thailand, Taiwan, Singapore and Malaysia said they already had deals or were negotiating supply contracts with Merck. The EU is considering buying the pill after Merck applies for authorization in Europe.

The eight generic manufacturers chosen by Merck all have WHO pre-qualified facilities to allow them to supply buyers like the Global Fund, according to Paul Schaper, Merck’s executive director of global public policy. They will set their pricing and decide how much they plan to manufacture.

“What we are anticipating and hoping for is that they will compete with each other on pricing,” Schaper said.

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REUTERS/Rachel Wisniewski

AstraZeneca’s experimental Covid-19 drug has helped cut the risk of severe disease or death in a late-stage study, the British drugmaker said on Monday, a boost to its efforts to develop coronavirus medicines beyond vaccines.

The drug, a cocktail of two antibodies called AZD7442, reduced the risk of severe Covid -19 or death by 50% in non-hospitalized patients who have had symptoms for seven days or less, meeting the main goal of the study.

AstraZeneca’s therapy, delivered via injection, is the first of its kind to show promise both as a preventative medicine and as a treatment for Covid -19 following multiple trials. It is designed to protect people who do not have a strong enough immune response to vaccines.

“These positive results show that a convenient intramuscular dose of AZD7442 could play an important role in helping combat this devastating pandemic,” Hugh Montgomery, the trial’s principal investigator, said in a statement.

Similar therapies made with a class of drugs called monoclonal antibodies are being developed by Regeneron, Eli Lilly and GlaxoSmithKline with partner Vir . These therapies are approved for emergency use in the United States for treating mild-to-moderate Covid-19.

AstraZeneca, whose Covid -19 vaccine has been widely used globally, asked U.S. regulators last week to grant emergency use authorisation for AZD7442 as a preventative therapy.

AstraZeneca is submitting data from various AZD7442 studies to global health regulators, a spokeswoman said on Monday.

“We’ll be continuing discussions with regulators around this new data,” she said of Monday’s trial results.

The trial took place across 13 countries and involved more than 900 adult participants, with one half receiving AZD7442 and the rest a placebo. Full trial results will be submitted for publication in a peer-reviewed journal, AstraZeneca said.

AZD7442 contains laboratory-made antibodies designed to linger in the body for months to contain the virus in case of an infection. A vaccine, in contrast, relies on an intact immune system to develop targeted antibodies and infection-fighting cells.

“An early intervention with our antibody can give a significant reduction in progression to severe disease, with continued protection for more than six months,” said Mene Pangalos, executive vice president at AstraZeneca.

While Monday’s results cover the use of AZD7442 in non-hospitalised patients, a separate trial is also studying its use as a treatment for hospitalised COVID-19 patients.

Other antibody cocktail treatments for Covid -19 have shown varied degrees of success.

Regeneron’s therapy showed 72% protection against symptomatic infection in the first week, and 93% after that. GSK-Vir’s showed a 79% reduction in the risk of hospitalisation or death due to any cause, while Lilly’s therapy showed a 70% reduction in viral load at day seven compared to a placebo.

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The World Health Organisation’s (WHO) new Mental Health Atlas paints a disappointing picture of a worldwide failure to provide people with the mental health services they need.

In a statement made available on Saturday, it said it happened at a time when the COVID-19 pandemic was highlighting a growing need for mental health support.

“World misses most 2020 mental health targets; extension of WHO Mental Health Action Plan to 2030 provides new opportunity for progress reading time, four minutes (1003 words).

“The latest edition of the atlas, which includes data from 171 countries, provides a clear indication that the increased attention given to mental health in recent years has yet to result in a scale-up of quality mental services that is aligned with needs,” the global health agency said.

According to WHO, the Atlas is a compilation of data provided by countries around the world on mental health policies, issued every three years.

Others are legislation, financing, human resources, availability and utilisation of services and data collection systems.

According to the global health body, it is also the mechanism for monitoring progress towards meeting the targets in WHO’s Comprehensive Mental Health Action Plan.

“It is extremely concerning that, despite the evident and increasing need for mental health services, which has become even more acute during the COVID-19 pandemic, good intentions are not being met with investment.

“We must heed and act on this wake-up call and dramatically accelerate the scale-up of investment in mental health, because there is no health without mental health,” it quoted Dr Tedros Ghebreyesus, the Director-General of WHO, as saying.

The statement said that none of the targets for effective leadership and governance for mental health, provision of mental health services in community-based settings, mental health promotion and prevention, and strengthening of information systems, were close to being achieved.

It said that in 2020, just 51 per cent of WHO’s 194 member states reported that their mental health policy or plan was in line with international and regional human rights instruments, way short of the 80 per cent target.

It said that only 52 per cent of countries met the target relating to mental health promotion and prevention programmes, also well below the 80 per cent target.

WHO noted that the only 2020 target met was a reduction in the rate of suicide by 10 per cent, but even then, only 35 countries said they had a stand-alone prevention strategy, policy or plan.

It said that steady progress was evident, however, in the adoption of mental health policies, plans and laws, as well as in improvements in capacity to report on a set of core mental health indicators.

It said that, however, the percentage of government health budgets spent on mental health has scarcely changed during the last years, still hovering around two per cent.
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AstraZeneca (AZN.L) has requested emergency use authorisation from US regulators for its new treatment to prevent COVID-19 for people who respond poorly to vaccines because of a weakened immune system.

In a statement on Tuesday, the Anglo-Swedish drugmaker said it included data in its filing with the Food and Drug Administration from a late-stage trial that showed the drug reduced the risk of people developing any COVID-19 symptoms by 77 per cent.

The antibody therapy called AZD7442 could protect people who do not have a strong enough immune response to COVID-19 vaccines or to supplement a vaccination course for those, such as military personnel, who need to booster their protection further, AstraZeneca has said.

While vaccines rely on an intact immune system to develop targeted antibodies and infection-fighting cells, AZD7442 contains lab-made antibodies designed to linger in the body for months to contain the virus in case of an infection.

A US authorisation for AZD7442 – based on two antibodies discovered by Vanderbilt University Medical Center in the United States – could be a major win for AstraZeneca, whose widely used COVID-19 vaccine has yet to be approved by US authorities.

Talks regarding supply agreements for AZD7442 are ongoing with the United States and other governments, AstraZeneca said.

COVID-19 therapies based on the same class of monoclonal antibodies are being developed by rivals Regeneron (REGN.O), Eli Lilly (LLY.N) and GlaxoSmithKline (GSK.L) with partner Vir (VIR.O), competing for a role in COVID-19 treatment and prevention. But Astra’s filing has cemented its lead in prevention.

That contrasts with delays in Astra’s quest for approval for its COVID-19 vaccine Vaxzevria in the United States, where the vast majority of those willing to get immunised have received shots from the Pfizer-BioNTech (PFE.N)(22UAy.DE) alliance, Moderna (MRNA.O) or Johnson & Johnson .

Astra said in July it expected to seek US approval for the vaccine in the second half of this year.

Trial results on the AZD7442 therapy, first published in August, were taken three months after injection but the company hopes it can tout the shot as a year-long shield as trial investigators will follow up with participants as far out as 15 months.

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A vial of the Moderna coronavirus disease (COVID-19) vaccine is pictured at a care home in Naples, Italy, March 30, 2021. REUTERS/Ciro De Luca

Positive clinical trial results for Merck & Co’s (MRK.N) experimental antiviral COVID-19 pill reverberated through the healthcare sector on Friday, sending the drugmaker’s stock price soaring while denting high-flying shares of vaccine companies and makers of other coronavirus therapies.

Merck shares jumped as much as 12.3 per cent and hit their highest level since February 2020 after data showed the company’s pill molnupiravir could halve the chances of dying or being hospitalized for those most at risk of contracting severe COVID-19. Experts hailed the news as potentially a huge advance in the fight against COVID-19.

At the same time, shares of vaccine makers such as Moderna Inc (MRNA.O), Pfizer Inc (PFE.N) and partner BioNTech SE were hit, with some analysts saying the promise of an oral drug that can be taken at home could change the public perception of risks associated with COVID-19.

“We see modest perceived headwind to vaccine stocks such as MRNA (Moderna) if the market thinks people will be less afraid of COVID-19 and less inclined to get vaccines, if there is a simple pill that can treat COVID-19,” Jefferies analyst Michael Yee said in a client note.

Moderna shares tumbled 13 per cent in midday trading, while Pfizer, which is developing a COVID-19 pill of its own, fell 1.3 per cent. US shares of BioNTech dropped 11 per cent.

For Moderna investors, the Merck news presented an opportunity to lock in gains after an already stunning run. Shares of Moderna, which were added to the S&P 500 in mid July, remain up some 220 per cent in 2021 despite Friday’s declines. BioNTech’s shares were also still up about 200 per cent for the year, even with Friday’s fall.

The Merck news is a “great reason for folks to be taking profits off the table” in Moderna and BioNTech shares, said Sahak Manuelian, head of equity trading at Wedbush Securities. “These moves can get exacerbated to the downside given the momentum they have had to the upside.”

Shares of other companies with COVID-19 vaccines also fell, with AstraZeneca (AZN.L) down 2 per cent and Novavax (NVAX.O) falling 16 per cent.

Companies with other COVID-19 therapies that are administered intravenously or through injection also traded lower, with Regeneron Pharmaceuticals In (REGN.O) down nearly 5 per cent and Gilead Sciences Inc (GILD.O) off about 2 per cent.

Healthcare (.SPXHC) was the only one of the 11 S&P 500 sectors in negative territory in mid-day trading, falling 0.5 per cent.

“We see molnupiravir, with its oral format as a clear game changer that is likely to meaningfully impact not just the treatment paradigm for COVID-19 but also has potential utility in the prevention setting,” Piper Sandler analyst Christopher Raymond said in a research note.

Merck is conducting a late-stage trial to see if its antiviral pill can prevent COVID-19 infection, in addition to the study that showed it can significantly cut hospitalization and death in those already infected.

Merck, whose shares were last up about 9 per cent, leads the race in developing the first oral antiviral medication for COVID-19. Rivals such as Pfizer and Swiss drugmaker Roche Holding AG (ROG.S) with partner Atea Pharmaceuticals Inc (AVIR.O) are running late-stage trials of their pills. Atea shares were up 19 per cent.

Merck, which discontinued its own COVID-19 vaccineprogram, had seen its shares fall about 4 per cent for the year through Thursday, before they moved into positive territory for 2021 on Friday.

“Merck has kind of been dead in the water to investors for the past couple of quarters,” said Kevin Gade, portfolio manager with Bahl & Gaynor, which owns Merck shares. “This shows their R&D engine is not dead and they were first … in what could be a multi-billion dollar opportunity.”

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The European Union’s drug regulator on Friday identified a possible link between rare cases of blood clotting in deep veins with Johnson & Johnson’s COVID-19 vaccine and recommended the condition be listed as a side-effect of the shot.

The European Medicines Agency also recommended that immune thrombocytopenia (ITP), a bleeding disorder caused by the body mistakenly attacking platelets, be added as an adverse reaction with an unknown frequency to the J&J vaccine product information and to AstraZeneca’s vaccine.

J&J said while the chances of experiencing these conditions were very low, the product information would be updated accordingly as it continues to work closely with authorities including EMA.

“We strongly support raising awareness of the signs and symptoms of rare events to ensure they can be quickly identified and effectively treated,” the company said.

Both the J&J and AstraZeneca vaccines have previously been associated with a very rare combination of blood clotting and low platelet counts known as thrombosis with thrombocytopenia syndrome (TTS).

The two products are based on harmless vector viruses that instruct human cells to make a protein that primes the immune system against future coronavirus infections.

EMA said the new, possibly life-threatening clotting condition known as venous thromboembolism (VTE) to be included on the J&J product label was separate from TTS.

VTE typically begins by a clot forming in a vein of a leg, arm or groin, which then travels to the lungs and blocks the blood supply there.

Regardless of any vaccine use, VTE is most commonly caused by injury or lack of movement in bedridden patients. Birth control pills and a number of chronic conditions are also seen as risk factors.

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An experimental COVID-19 treatment pill called molnupiravir being developed by Merck

Merck & Co Inc’s experimental oral drug for COVID-19, molnupiravir, reduced by around 50% the chance of hospitalization or death for patients at risk of severe disease, according to interim clinical trial results announced on Friday.

Merck and partner Ridgeback Biotherapeutics plan to seek U.S. emergency use authorization for the pill as soon as possible, and to submit applications to regulatory agencies worldwide. Due to the positive results, the Phase 3 trial is being stopped early at the recommendation of outside monitors.

“This is going to change the dialogue around how to manage COVID-19,” Robert Davis, Merck’s chief executive officer, told Reuters.

If authorized, molnupiravir, which is designed to introduce errors into the genetic code of the virus, would be the first oral antiviral medication for COVID-19.

The news sent Merck’s shares up almost 8% in pre-market New York trading.

Rivals including Pfizer Inc and Swiss pharmaceutical Roche Holding AG are racing to develop an easy-to-administer antiviral pill for COVID-19 but so far, only antibody cocktails – which have to be given intravenously – are approved for treating non-hospitalized COVID-19 patients.

A planned interim analysis of 775 patients in Merck’s study found that 7.3% of those given molnupiravir were either hospitalized or had died by 29 days after treatment, compared with 14.1% of placebo patients. There were no deaths in the molnupiravir group, but there were eight deaths of placebo patients.

“Antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed,” Wendy Holman, Ridgeback’s CEO, said in a statement.

Scientists welcomed the potential new treatment to help prevent serious illness from the virus, which has killed almost 5 million people around the world.

“The availability of a well-tolerated, effective oral antiviral will be particularly useful in supplementing vaccination as a means to reduce the proportion of patients needing hospital care,” Professor Penny Ward, visiting professor in pharmaceutical medicine at King’s College London.

In the trial, which enrolled patients around the world, molnupiravir was taken every 12 hours for five days.

The study enrolled patients with laboratory-confirmed mild-to-moderate COVID-19, who had symptoms for no more than five days. All patients had at least one risk factor associated with poor disease outcome, such as obesity or older age.

Merck said viral sequencing done so far shows molnupiravir is effective against all variants of the coronavirus, including highly transmissible Delta.

The company said rates of adverse events were similar for both molnupiravir and placebo patients, but did not give details of the side effects.

Merck has said data shows molnupiravir is not capable of inducing genetic changes in human cells, but men enrolled in its trials have to abstain from heterosexual intercourse or agree to use contraception. Women of child-bearing age cannot be pregnant and also have to use birth control.

Merck said it expects to produce 10 million courses of the treatment by the end of 2021, with more doses coming next year.

The company has a U.S. government contract to supply 1.7 million courses of molnupiravir at a price of $700 per course.

CEO Davis said Merck has similar agreements with other governments worldwide, and is in talks with more. The company said it plans to implement a tiered pricing approach based on country income criteria.

Merck has also agreed to license the drug to several India-based generic drugmakers, which would be able to supply the treatment to low- and middle-income countries.

Molnupiravir is also being studied in a Phase 3 trial for preventing coronavirus infection in people exposed to the virus.

Merck officials said it is unclear how long the FDA review of the drug will take.

“I believe that they are going to try to work with alacrity on this,” said Dean Li, head of Merck’s research labs.

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3.2 million Israelis have received a third jab REUTERS/Amir Cohen/File Photo

Israel’s Health Ministry has identified fewer than 10 cases of heart inflammation following a third dose of the Pfizer/BioNtech vaccine among millions administered, according to recently released data.

Israel began administering boosters to risk groups in July and by the end of August expanded its campaign to include anyone above the age of 12, five months or more after a second dose.

Having kicked off its rapid vaccination drive relatively early, in December, Israel was one of the first countries to report that the vaccine’s protection diminished with time, and has since deemed its booster campaign safe and effective.

The booster drive is being watched closely in the United States, where third Pfizer shots have been rolled out for those 65 and older, all people at high risk of severe disease, and others who are regularly exposed to the virus.

In data published late on Thursday, the Health Ministry reported nine cases of myocarditis within four age groups that comprised more than 1.5 million people who had received a booster shot.

All were male, three were between the ages of 16 and 29 and six were in the 30-59 group. Eight more possible cases were still being reviewed. Most myocarditis cases are generally mild, the ministry said.

In total, out of all 3.2 million Israelis who have received a third jab, 25 reported serious adverse events that appeared within 30 days of the shot, including myocarditis, though a causal link had yet to be established among many of them.

Employing a “living with COVID” strategy, the government is hoping that the boosters, so far administered to around a third of the 9.3 million population, will fend off an outbreak of the Delta variant while the economy is kept open.

Since Delta began spreading in June, the government has reimposed indoor mask wearing and Israelis require a Green Pass – a digital document that confirms full immunisation, including a third shot, or recovery from the illness – to enter most places of leisure. Teachers must either be vaccinated or get tested in order to enter schools.

The number of COVID-19 patients hospitalised in serious condition has been dropping in recent days, as has the number of confirmed daily cases, which now stand at around 4,000, compared with around 8,000 a month ago.

But experts are concerned that, with schools reopening this week after the Jewish high holiday season, illness will shoot up again. They have urged the government to take more steps to rein in infections, such as limiting large crowds, and not to rely on boosters alone.