Living with COVID-19: Israel changes strategy as Delta variant hits

By Maayan Lubell

JERUSALEM (Reuters) – Four weeks ago, Israel was celebrating a return to normal life in its battle with COVID-19.

After a rapid vaccination drive that had driven down coronavirus infections and deaths, Israelis had stopped wearing face masks and abandoned all social-distancing rules.

Then came the more infectious Delta variant, and a surge in cases that has forced Prime Minister Naftali Bennett to reimpose some COVID-19 restrictions and rethink strategy.

Under what he calls a policy of “soft suppression,” the government wants Israelis to learn to live with the virus – involving the fewest possible restrictions and avoiding a fourth national lockdown that could do further harm to the economy.

As most Israelis in risk groups have now been vaccinated against COVID-19, Bennett is counting on fewer people than before falling seriously ill when infections rise.

“Implementing the strategy will entail taking certain risks but in the overall consideration, including economic factors, this is the necessary balance,” Bennett said last week.

The main indicator guiding the move is the number of severe COVID-19 cases in hospital, currently around 45. Implementation will entail monitoring infections, encouraging vaccinations, rapid testing and information campaigns about face masks.

The strategy has drawn comparisons with the British government’s plans to reopen England’s economy from lockdown, though Israel is in the process of reinstating some curbs while London is lifting restrictions.

The curbs that have been reinstated include the mandatory wearing of face masks indoors and quarantine for all people arriving in Israel.

Bennett’s strategy, like that of the British government, has been questioned by some scientists.

Israel’s Health Ministry advocates more of a push for stemming infections, Sharon Alroy-Preis, head of public health at Israel’s Health Ministry, told Kan Radio on Sunday.

“It’s possible that there won’t be a big rise in the severely ill but the price of making such a mistake is what’s worrying us,” she said.

But many other scientists are supportive.

“I am very much in favor of Israel’s approach,” said Nadav Davidovitch, director of the school of public health at Israel’s Ben Gurion University, describing it as a “golden path” between Britain’s easing of restrictions and countries such as Australia that take a tougher line.

THE VIRUS ‘WON’T STOP’

Israel’s last lockdown was enforced in December, about a week after the start of what has been one of the world’s fastest vaccination programs.

New daily COVID-19 infections are running at about 450. The Delta variant, first identified in India, now makes up about 90% of cases.

“We estimate that we won’t reach high waves of severe cases like in previous waves,” the health ministry’s director-general, Nachman Ash, said last week. “But if we see that the number and increase rate of severe cases are endangering the (health) system, then we will have to take further steps.”

Around 60% of Israel’s 9.3 million population have received at least one shot of the Pfizer/BioNtech vaccine. On Sunday, the government began offering a third shot to people with a compromised immune system.

Ran Balicer, chair of the government’s expert panel on COVID-19, said Israel had on average had about five severe cases of the virus and one death per day in the last week, after two weeks of zero deaths related to COVID-19.

Noting the impact of the Delta variant, he said the panel was advising caution over the removal of restrictions.

“We do not have enough data from our local outbreak to be able to predict with accuracy what would happen if we let go,” Balicer said.

Some studies have shown that though high, the Pfizer/BioNTech vaccine’s effectiveness against the Delta variant is lower than against other coronavirus strains.

Drawing criticism from some scientists, Pfizer and BioNTech SE have said they will ask U.S. and European regulators to authorize booster shots to head off increased risk of infection six months after inoculation.

Israel is in no rush to approve public booster shots, saying there is no unequivocal data yet showing they are necessary. It is offering approval only to people with weak immune systems on a case-by-case basis.

Authorities are also considering allowing children under 12 to take the vaccine on a case-by-case basis if they suffer from health conditions that put them at high risk of serious complications if they were to catch the virus.

Only “a few hundred” of the 5.5 million people who have been vaccinated in Israel have later been infected with COVID-19, Ash said.

Before the Delta variant arrived, Israel had estimated 75% of the population would need to be vaccinated to reach “herd immunity” – the level at which enough of a population are immunized to be able to effectively stop a disease spreading. The estimated threshold is now 80%.

Such data ensure doctors remain concerned.

“…the virus won’t stop. It is evolving, it’s its nature. But our nature is to survive,” said Dr. Gadi Segal, head of the coronavirus ward at Sheba Medical Centre near Tel Aviv.

(Writing by Maayan Lubell; Editing by Jeffrey Heller and Timothy Heritage)

Moderna files for U.S. authorization to use its COVID-19 vaccine in teens

(Reuters) – Moderna Inc said on Thursday it has filed for U.S. authorization to use its COVID-19 vaccine in adolescents aged 12 through 17, potentially offering healthcare providers and pediatricians an easier-to-store shot ahead of the return-to-school season in the fall.

The company is the second drugmaker to seek regulatory nod for use of its vaccine in the age group, as the U.S. tries to vaccinate more young people.

Vaccinating children has been considered key to achieving “herd immunity” and while they mostly develop only mild COVID-19 symptoms or no symptoms, younger people still remain at risk of becoming seriously ill, and can spread the virus.

Moderna’s vaccine is already being used in the United States, the European Union and Canada for anyone over 18. The drugmaker said it has also submitted applications to European and Canadian regulators seeking authorization for the shot’s use in adolescents.

Last month, Moderna’s two-shot vaccine was shown to be effective in adolescents aged 12-17 and showed no new or major safety problems in a clinical trial which evaluated the vaccine in 3,732 teenagers.

The U.S. has already authorized Pfizer Inc and German partner BioNTech SE’s COVID-19 vaccine for use in children as young as 12.

More than 7 million teens have received at least one dose of the vaccine in the United States, according to the U.S. Centers for Disease Control and Prevention.

(Reporting by Manojna Maddipatla and Ankur Banerjee in Bengaluru; Editing by Bernard Orr and Shounak Dasgupta)

Pfizer to test COVID-19 vaccine in larger group of children below 12

By Michael Erman and Ankur Banerjee

(Reuters) – Pfizer Inc said on Tuesday it will begin testing its COVID-19 vaccine in a larger group of children under age 12 after selecting a lower dose of the shot in an earlier stage of the trial.

The study will enroll up to 4,500 children at more than 90 clinical sites in the United States, Finland, Poland and Spain, the company said.

Based on safety, tolerability and the immune response generated by 144 children in a phase I study of the two-dose shot, Pfizer said it will test a dose of 10 micrograms in children between 5 and 11 years of age, and 3 micrograms for the age group of 6 months to 5.

A Pfizer spokesperson said the company expects data from 5- to 11-year-olds in September and would likely ask regulators for emergency use authorization later that month. Data for children 2 to 5 years old could arrive soon after that, he said.

Pfizer expects to have data from the 6-month to 2-year-old age group sometime in October or November.

The vaccine – made by Pfizer and German partner BioNTech SA – has been authorized for use in children as young as 12 in Europe, the United States and Canada. They receive the same dose as adults: 30 micrograms.

Nearly 7 million teens have received at least one dose of the vaccine in the United States, according to the U.S. Centers for Disease Control and Prevention.

Inoculating children and young people is considered a critical step toward reaching “herd immunity” and taming the COVID-19 pandemic.

Still, scientists in the United States and elsewhere are studying the possibility of a link between heart inflammation and mRNA vaccines, particularly in young men. Both Pfizer and Moderna Inc’s vaccines are mRNA shots.

Israel’s Health Ministry said last week it had found the small number of myocarditis cases observed mainly in young men who received the Pfizer vaccine there were probably linked to their vaccination. The cases were generally mild and did not last long.

Pfizer has said it is aware of the Israeli observations of myocarditis and that no causal link to its vaccine has been established.

(Reporting by Ankur Banerjee in Bengaluru and Michael Erman in New York; Editing by Arun Koyyur, Will Dunham and Mark Heinrich)

German COVID-19 cases are growing exponentially again: RKI

BERLIN (Reuters) – Coronavirus infections are rising exponentially in Germany, an expert at the Robert Koch Institute for infectious diseases said on Tuesday, putting at risk plans to lift the lockdown and revive the economy.

The number of cases per 100,000 reported on Tuesday was 83.7, up from 68 a week ago, and the RKI has said that metric could reach 200 by the middle of next month.

Germany is definitely in a third wave of the pandemic, driven by the fact it has loosened restrictions in recent weeks just as a more transmissible variant has spread, Dirk Brockmann, an epidemiologist at the RKI, told Germany’s ARD television.

“It has been totally irrational to loosen up here. It is just fueling this exponential growth,” he said.

Chancellor Angela Merkel and state leaders agreed a phased easing of curbs earlier this month along with an “emergency brake” to let authorities reimpose restrictions if case numbers rise above 100 per 100,000 on three consecutive days.

They are due to meet again on March 22 to discuss whether to allow any further relaxation of the rules.

The state government in the city of Berlin decided on Tuesday to put on hold any more easing, such as allowing restaurants or cinemas to open, the Tagesspiegel newspaper reported.

VACCINATION WOES

Germany’s decision on Monday to suspend AstraZeneca’s vaccine could delay progress in reaching herd immunity and postpone an economic recovery in the second quarter, analysts said.

The decision follows seven cases of thrombosis in Germany, including three deaths, and delivers a major setback to the country’s drive to speed up its sluggish vaccination campaign.

A planned meeting between Merkel and state leaders on Wednesday to discuss using family doctors to administer COVID-19 vaccines has been postponed until after the European Medicines Agency completes its review into the AstraZeneca shot.

AstraZeneca has said an analysis of its safety data covering reported cases from over 17 million vaccine doses given had shown no evidence of an increased risk of pulmonary embolism, deep vein thrombosis or low levels of platelets.

The RKI’s Brockmann noted that 1,000 people in a million had died of COVID-19, compared to possibly 1 in a million from complications associated with the vaccine.

“In the risk groups, the risk of dying of COVID is much, much higher. That means it is probably 100,000 times more likely to die of COVID than because of an AstraZeneca vaccine,” he said.

(Reporting by Emma Thomasson and Caroline Copley, Editing by Timothy Heritage and Gareth Jones)

Israel sharing COVID-19 data with Pfizer to help fine-tune vaccine rollout

JERUSALEM (Reuters) – Israel is giving weekly data updates on its COVID-19 outbreak to vaccine maker Pfizer under a collaboration agreement that may help other countries fine-tune their inoculation campaigns and achieve “herd immunity,” officials said.

Israelis began receiving first shots of the vaccine developed by Pfizer and its German partner BioNTech on Dec. 19 in one of the world’s fastest vaccination rollouts.

Israel’s Health Ministry made public most of a 20-page collaboration agreement it signed with Pfizer, which said the aim was “to determine whether herd immunity is achieved after reaching a certain percentage of vaccination coverage in Israel”.

Commercial details such as price and quantity of vaccine shots supplied were not made public, but the agreement said that Israel was relying on Pfizer to deliver enough doses at a fast enough rate to allow it to achieve “herd immunity,” meaning a sufficient portion of the population is immune to the virus.

“While this project is conducted in Israel, the insights gained will be applicable around the world and we anticipate will allow governments to maximize the public health impact of their vaccination campaigns,” BioNTech said on Monday in a statement.

This includes determining potential immunization rates needed to stop the virus from spreading, it said.

The goal, BioNTech said, was “to monitor the evolution of the epidemic over time and at different vaccination rates.”

“This will help us understand whether a potential decrease in cases and deaths can be attributed solely to direct vaccine protection or to both direct and indirect (or ‘herd’) protection,” it said.

During weekly status reports, Israel will provide Pfizer with epidemiological data such as: the number of confirmed COVID-19 cases, hospitalizations, how many patients were on ventilators, how many died, as well as an age and other demographic breakdown.

Such data was available to the public and keeps patients anonymous, Israeli officials said.

About a quarter of Israelis have received their first vaccine shot and 3.5% already got their second dose.

Still, the country is in its third lockdown with infection rates remaining high. More than half a million cases have been reported and 4,005 people have died in Israel since the pandemic began.

(Reporting by Ari Rabinovitch, Ludwig Burger, Nikolaj Skydsgaard and Steven Scheer; Editing by Alex Richardson)

Fauci says herd immunity could require nearly 90% to get coronavirus vaccine

By Jonathan Allen

(Reuters) – Herd immunity against the novel coronavirus could require vaccination rates approaching as high as 90%, Dr. Anthony Fauci, the most prominent U.S. infectious disease expert, said in an interview published on Thursday.

More than 1 million Americans have received a first dose of a vaccine since Dec. 14, according to the U.S. Centers for Disease Control, or only about 0.3% of the population.

Fauci acknowledged that he had incrementally increased his estimates from earlier in the year, when he tended to say only 60% to 70% would need to be inoculated for herd immunity to be reached.

“We need to have some humility here,” Fauci told the New York Times. “We really don’t know what the real number is. I think the real range is somewhere between 70 to 90 percent. But, I’m not going to say 90 percent.”

His comments came as the country marks grim new daily milestones while contending with the world’s deadliest outbreak: it reported more than 3,000 deaths for the second consecutive day on Wednesday. The U.S. death toll reached 326,333 by midnight on Wednesday, according to Reuters data.

That same day, more Americans flew than on any other day since the pandemic emerged in March, with 1,191,123 passengers passing through airport checkpoints, according to data from the U.S. Transportation Security Administration.

The data suggested many were disregarding public health experts’ advice to avoid traveling to celebrate Christmas Day on Friday. Fauci and other experts say social distancing will be required deep into 2021 as vaccines are slowly rolled out.

The number of travelers was down from 2019, when 1,937,235 flew on Dec. 23. Wednesday’s traffic exceeded the previous pandemic-era high set on Nov. 29, the Sunday after the Thanksgiving holiday, when 1,176,091 people passed through TSA checkpoints, preceding new surges in coronavirus cases in many states.

Health care workers, elderly nursing home residents, elected officials and firefighters are among those receiving the vaccines first. Most Americans have been told it could be six months or more before they are eligible for the shots.

Fauci, who was appointed director of the National Institute of Allergy and Infectious Diseases in 1984, said in the interview that he had become more willing to reveal his beliefs as polls show Americans were becoming somewhat less skeptical about the new vaccines. The more infectious a disease is, the higher the rate of vaccination is required to reach a threshold of herd immunity, in which its spread is contained.

“When polls said only about half of all Americans would take a vaccine, I was saying herd immunity would take 70 to 75 percent,” Fauci, who turned 80 on Thursday, told the Times.

“Then, when newer surveys said 60 percent or more would take it, I thought, ‘I can nudge this up a bit,’ so I went to 80, 85.'”

(Reporting by Jonathan Allen in New York; Additional reporting by Anurag Maan in Bangalore; Editing by Dan Grebler)

We may soon have a COVID-19 vaccine. But will enough people take it?

By John Miller and Kate Kelland

ZURICH/LONDON (Reuters) – With COVID-19 vaccine trial results looking positive, governments and pharmaceutical firms face their next daunting challenge: convincing the world to get inoculated.

Public resistance to vaccines has been much discussed this year, but the issue became very real on Monday when Pfizer and BioNTech announced their candidate was more than 90% effective in large trials – hoisting an actual shot onto the horizon.

Numerous opinion polls carried out before and during the pandemic showed confidence is volatile, and that political polarization and online misinformation threatens uptake. Many people have concerns about the accelerated speed of COVID-19 vaccine development.

The World Health Organization estimates about 70% of people must be inoculated to break transmission of the virus. Since it is unlikely a vaccine, once approved, will be immediately available for the masses, experts said getting medical workers on board will be critical.

“We should have really targeted discussions and engagement with healthcare providers,” Heidi Larson, director of the global Vaccine Confidence Project, told Reuters.

“Not only are they going to be the first ones expected to get a vaccine – if not required to – they’re also going to be the ones on the frontlines facing the onslaught of questions from the public.”

FIRST IN LINE?

While about 200 COVID-19 vaccine candidates are in development globally, with dozens in human clinical trials, no shot has actually crossed the finish line and been approved, though the one from Pfizer-BioNTech appears to be on track.

The high rate of efficacy in the Pfizer-BioNTech interim results could help boost confidence, Cornell University government Professors Douglas Kriner and Sarah Kreps said.

Their recently published research showed that if an initial COVID-19 vaccine was about as effective as a flu shot, uptake by the American public may fall far short of the 70% level needed to achieve “herd immunity.”

“However, if the vaccine was 90% effective it would significantly increase Americans’ willingness to vaccinate by more than 10%, critical to ensuring enough public acceptance to help the U.S. eventually get closer to herd immunity,” said Kreps.

Experts are also cautioning any conversation over a vaccine’s risks and rewards must be frank. A return to normal life will still take time, with no one shot likely to be a silver bullet. And many questions are likely to remain, including how long a vaccine will provide protection.

The Reagan-Udall Foundation for the FDA, a non-profit that supports the U.S. Food and Drug Administration, has been holding focus groups to gauge the public mood and is now crafting campaign messages to help tackle concerns.

Its chief executive, Susan Winckler, said more than a dozen focus groups of 150 people in total held since August – some in person, some by video – had unearthed numerous concerns.

“We heard distrust of both government and the healthcare system,” Winckler said. “Many didn’t want to be first in line for the shot.”

It’s a global phenomenon; a survey from early November, carried out by the World Economic Forum and covering 18,526 people in 15 countries, showed 73% of people willing to get a COVID-19 vaccine, a four-point fall since August.

EARLY BATTLE

Regulators and the drug industry have taken pains to reassure the public they won’t cut corners on safety, with a top U.S. drug agency official saying he would quit if an unproven vaccine were rubber stamped.

The International Federation of Pharmaceutical Manufacturers & Associations, a drug industry group, also plans a campaign by 2021, while the U.S. Council for International Business, with 300 multinational corporations as members, is also getting behind a campaign pushing for workforce take-up of eventual COVID-19 vaccines.

Some studies show government and employer recommendations will help convince people to get vaccinated.

Scott Ratzan, co-leader with Larson of ‘CONVINCE’, an initiative supporting communication and engagement for vaccine uptake globally, stressed the importance of medical workers getting inoculated, saying others would then be more likely to follow suit.

“If we don’t have the medical folks signed on … we’ll lose the early battle,” he added. “The only way to get back to normal is if we can get enough workers or employees covered.”

(Reporting by John Miller in Zurich and Kate Kelland in London; Additional reporting by Martinne Geller in London, Doug Busvine in Frankfurt and Julie Steenhuysen in Chicago; Editing by Josephine Mason and Pravin Char)

Explainer: When will COVID-19 vaccines be generally available in the U.S.?

By Carl O’Donnell and Michael Erman

(Reuters) – U.S. President Donald Trump and the head of the Centers for Disease Control and Prevention (CDC) this week disagreed about when a COVID-19 vaccine would become widely available. Trump has said one could initially be available by the Nov. 3 election, while the CDC director said vaccines were likely to reach the general public around mid-2021, an assessment more in line with most experts.

WHAT DOES IT MEAN FOR A VACCINE TO BE GENERALLY AVAILABLE?

General availability is when every American who wants the vaccine can get it. There are currently no COVID-19 vaccines approved by U.S. regulators, although a handful are in late-stage trials to prove they are safe and effective.

Experts estimate that at least 70% of roughly 330 million Americans would need to be immune through a vaccine or prior infection to achieve what is known as herd immunity, which occurs when enough people are immune to prevent the spread of the virus to those unable to get a vaccine.

HOW LONG BEFORE VACCINE PRODUCTION IS FULLY RAMPED UP?

Most vaccines in development will require two doses per person.

The CDC anticipates that 35 million to 45 million doses of vaccines from the first two companies to receive authorization will be available in the United States by the end of this year. The current front runners are Pfizer Inc and Moderna Inc.

Drugmakers have been more ambitious with their calculations. AstraZeneca Plc has said it could deliver as many as 300 million doses of its experimental vaccine in the United States by as early as October. Pfizer and German partner BioNTech SE have said they expect to have 100 million doses available worldwide by the end of 2020, but did not specify how much of that was earmarked for the United States. Moderna on Friday said it is on track to make around 20 million doses by the end of the year and between 500 million and 1 billion doses a year beginning in 2021.

Obtaining enough doses to inoculate everyone in the United States will likely take until later in 2021. CDC Director Robert Redfield told a congressional hearing on Wednesday that vaccines may not be widely available to everyone in the United States until the second or third quarter of next year.

WHO WOULD GET AN APPROVED VACCINE FIRST?

The CDC decision will likely broadly follow recommendations from the National Academies of Sciences, Engineering and Medicine. The CDC has said the earliest inoculations may go to healthcare workers, people at increased risk for severe COVID-19, and essential workers.

It is unclear when a vaccine will be available for children as major drugmakers have yet to include them in late-stage trials. Pfizer and BioNTech have filed with regulators seeking to start recruiting volunteers as young as 16 for vaccine studies.

WHICH COMPANIES WILL LIKELY ROLL OUT A VACCINE QUICKLY?

Pfizer has said it could have compelling evidence that its vaccine works by the end of October. Moderna says it could have similar evidence in November. The vaccines would first need to be approved or authorized for emergency use by U.S. regulators.

Drugmakers have already started manufacturing supplies of their vaccine candidates to be ready as soon as they get the go ahead. The U.S. Department of Defense and the CDC plan to start distribution of vaccines within 24 hours of regulatory authorization.

Several drugmakers including Pfizer, AstraZeneca, Johnson & Johnson and Novavax Inc have all said they expect to produce at least 1 billion doses of their vaccines next year if they get regulatory authorization.

Sanofi SA and GlaxoSmithKline Plc are also working on developing a vaccine they say could be authorized next year.

(Reporting by Carl O’Donnell and Michael Erman in New York; additional reporting by Caroline Humer; editing by Peter Henderson and Bill Berkrot)