In Israel’s COVID-19 wards, doctors are learning which vaccinated patients are most vulnerable to severe illness, amid growing concerns about instances in which the shots provide less protection against the worst forms of the disease.
Around half of the country’s 600 patients presently hospitalized with severe illness have received two doses of the Pfizer Inc shot, a rare occurrence out of 5.4 million fully vaccinated people.
The majority of these patients received two vaccine doses at least five months ago, are over the age of 60 and also have chronic illnesses known to exacerbate a coronavirus infection. They range from diabetes to heart disease and lung ailments, as well as cancers and inflammatory diseases that are treated with immune-system suppressing drugs, according to Reuters interviews with 11 doctors, health specialists and officials.
Such “breakthrough” cases have become central to a global debate over whether highly vaccinated countries should give booster doses of COVID-19 vaccines, and to which people.
Israel began offering booster doses to people age 60 and up in July, and has since expanded that eligibility.
The United States, citing data out of Israel and other findings, said on Wednesday it would make booster doses available to all Americans beginning in September.
Other countries, including France and Germany, have so far limited their booster plans to the elderly and people with weak immune systems.
“The vaccinated patients are older, unhealthy, often they were bedridden before infection, immobile and already requiring nursing care,” said Noa Eliakim-Raz, head of the coronavirus ward at Rabin Medical Centre in Petach Tikva.
In contrast, “the unvaccinated COVID patients we see are young, healthy, working people and their condition deteriorates rapidly,” she said. “Suddenly they’re being put on oxygen or on a respirator.”
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Israel’s Health Ministry raised new alarm this week with a report showing the effectiveness against severe disease of the Pfizer vaccine, developed with Germany’s BioNTech, appeared to have dropped from more than 90% to 55% in people age 65 and up who received their second jab in January.
Disease experts say it is not clear how representative the figures are, but agree it is concerning given evidence that overall vaccine protection against infection is waning.
They cannot say whether that is due to the amount of time that has passed since inoculation, the ability of the highly contagious Delta variant to evade protection, the age and underlying health of the people vaccinated, or a combination of all of these factors.
Health officials in the UK and United States, two other nations with high vaccination rates and a spike in Delta infections, have reported similar trends.
In the UK, about 35% of the people hospitalized with a Delta case in recent weeks had received two doses of a COVID-19 vaccine. Nearly three-quarters of U.S. breakthrough infections that led to hospitalization or death were among people age 65 or older, according to federal data.
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U.S. officials said their booster plan is based on concern that over time, the vaccines will provide less protection against severe disease, including among younger adults.
“We are watching other countries carefully and (are) concerned that we too will see what Israel is seeing, which is worsening infections over time” among vaccinated people, U.S. Centers for Disease Control and Prevention Director Rochelle Walensky said at a press conference on Wednesday.
The World Health Organization has repeatedly urged wealthy nations to refrain from providing boosters while much of the world has yet to access their first COVID vaccine doses.
Immune response may not have triggered at all in some
The Delta variant, first identified in India, has become the dominant version of the SARS-CoV-2 virus globally, accelerating a pandemic that has killed more than 4.4 million people.
In Israel, daily new cases have increased from the single digits in June to around 8,000 since the arrival of Delta. Approximately half of the cases – the majority of them mild to moderate – are in vaccinated people.
Those vaccinated first in Israel were at high-risk, including people age 60 and up. The immune response of some may have weakened by the time Delta hit Israel. But for others with underlying health conditions, the vaccine may have not kicked in at all.
“For some of them the vaccine did not trigger an immune response, they had no antibodies, because of the illness itself or because they are treated with medication that suppresses the immune system,” said Dror Mevorach, who heads the coronavirus ward at Hadassah hospital in Jerusalem. He cited examples such as chronic lymphocytic leukemia and lymphoma.
Among 3 million vaccinated Israelis covered by Clalit, the country’s largest healthcare provider, 600 have suffered severe breakthrough cases since June. Around 75% of them were above the age of 70 and were at least 5 months after their second dose, according to Ran Balicer, Clalit’s chief innovation officer. Nearly all of them have chronic illnesses.
“We are hardly seeing young vaccinated people in severe condition,” said Balicer.
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In the UK, doctors described similar characteristics among vaccinated patients who fall severely ill.
“In those people who come in, because of their age, because of their co-morbidities, they might be people that you would expect that the vaccine is not quite so efficacious as other age groups,” said Tom Wingfield, a clinical lecturer at the Liverpool School of Tropical Medicine.
A new surge in U.S. coronavirus cases and deaths has been fueled by Delta, particularly in states where vaccination rates remain low. Among vaccinated patients who become infected, there is evidence of older people being hit harder.
In Texas, 92% of the vaccine breakthrough cases that resulted in death were in people over the age of 60 and 75% had a known underlying condition that put them at high risk from COVID-19, according to a public health department spokesperson.
Initial data in Israel suggests the booster shots administered in the last few weeks are reducing the risk of infection in older people compared with those who have received only two doses.
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Even without boosters, Israeli doctors say that vaccinated patients tend to recover more quickly.
“The vaccinated patients I’ve treated usually left the ICU in about three days. The unvaccinated patients took a week or two until they stabilized,” said Yael Haviv-Yadid, head of the critical care ward at Sheba Medical Centre near Tel Aviv.
Even if the vaccine did not stop them getting ill, it may have mitigated their illness, said Alex Rozov, head of the coronavirus ward at Barzilai Medical Centre in Ashkelon.
“Our cautious impression is that the vaccinated patients suffer an easier course of illness – the treatment is more effective among those who have antibodies.”
(Additional reporting by Alistair Smout and Josephine Mason in London, Carl O’Donnell in New York; Editing by Michele Gershberg and Dan Grebler)
© 2021 Reuters
FDA panel rejects plan to offer Pfizer booster shots against COVID-19 to most Americans – WAGM
WASHINGTON (AP) — Dealing the White House a stinging setback, a government advisory panel overwhelmingly rejected a plan Friday to give Pfizer COVID-19 booster shots across the board, and instead endorsed the extra vaccine dose only for those who are 65 or older or run a high risk of severe disease.
The twin votes represented a heavy blow to the Biden administration’s sweeping effort, announced a month ago, to shore up nearly all Americans’ protection amid the spread of the highly contagious delta variant.
The nonbinding recommendation — from an influential committee of outside experts who advise the Food and Drug Administration — is not the last word. The FDA will consider the group’s advice and make its own decision, probably within days. And the Centers for Disease Control and Prevention is set to weigh in next week.
In a surprising turn, the advisory panel rejected, 16-2, boosters for almost everyone. Members cited a lack of safety data on extra doses and also raised doubts about the value of mass boosters, rather than ones targeted to specific groups.
Then, in an 18-0 vote, it endorsed extra shots for people 65 and older and those at risk of serious disease. Panel members also agreed that health workers and others who run a high risk of being exposed to the virus on the job should get boosters, too.
That would help salvage part of the White House’s campaign but would still be a huge step back from the far-reaching proposal to offer third shots of both the Pfizer and Moderna vaccines to Americans eight months after they get their second dose.
The White House sought to frame the action as progress.
“Today was an important step forward in providing better protection to Americans from COVID-19,” said White House spokesman Kevin Munoz. “We stand ready to provide booster shots to eligible Americans once the process concludes at the end of next week.”
The CDC has said it is considering boosters for older people, nursing home residents and front-line health care workers, rather than all adults.
The FDA and CDC will most likely decide at some later point whether people who received the Moderna or Johnson & Johnson shots should get boosters.
During several hours of vigorous debate Friday, members of the panel questioned the value of offering boosters to almost everybody 16 and over.
“I don’t think a booster dose is going to significantly contribute to controlling the pandemic,” said Dr. Cody Meissner of Tufts University. “And I think it’s important that the main message we transmit is that we’ve got to get everyone two doses.”
Dr. Amanda Cohn of the CDC said, “At this moment it is clear that the unvaccinated are driving transmission in the United States.”
In a statement, Kathrin U. Jansen, Pfizer head of vaccine research and development, said the company continues to believe that boosters will be a “critical tool in the ongoing effort to control the spread of this virus.”
Scientists inside and outside the government have been divided recently over the need for boosters and who should get them, and the World Health Organization has strongly objected to rich nations giving a third round of shots when poor countries don’t have enough vaccine for their first.
While research suggests immunity levels in those who have been vaccinated wane over time and boosters can reverse that, the Pfizer vaccine is still highly protective against severe illness and death, even amid the delta variant.
The unexpected turn of events could reinforce criticism that the Biden administration got out ahead of the science in its push for boosters. President Joe Biden promised early on that his administration would “follow the science,” in the wake of disclosures of political meddling in the Trump administration’s coronavirus response.
The FDA panel’s overwhelming initial rejection came despite full-throated arguments about the need for boosters from both Pfizer and health officials from Israel, which began offering boosters to its citizens in July.
Sharon Alroy-Preis of Israel’s Ministry of Health said the booster dose improves protection tenfold against infection in people 60 and older.
“It’s like a fresh vaccine,” bringing protection back to original levels and helping Israel “dampen severe cases in the fourth wave,” she said.
Representatives for Pfizer argued that it is important to start shoring up immunity before protection begins to erode. A company study of 44,000 people showed effectiveness against symptomatic COVID-19 was 96% two months after the second dose, but had dropped to 84% by around six months.
Both Pfizer and the Israeli representatives faced pushback from panelists. Several were skeptical about the relevance of Israel’s experience to the U.S. Another concern was whether third doses would exacerbate serious side effects, including rare instances of heart inflammation in younger men.
Pfizer pointed to Israeli data from nearly 3 million boosters to suggest side effect rates would be similar to those already reported.
Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia, said he was supportive of a third dose for adults over 60 or 65, but “I really have trouble” supporting it for anyone down to age 16.
While an extra shot would probably at least temporarily reduce cases with mild or no symptoms, “the question becomes what will be the impact of that on the arc of the pandemic, which may not be all that much,” Offit said.
Biden’s top health advisers, including the heads of the FDA and CDC, first announced plans for widespread booster shots in mid-August, setting the week of Sept. 20 as an all-but-certain start date. But that was before FDA staff scientists had completed their own assessments of the data.
Earlier this week, two top FDA vaccine reviewers joined a group of international scientists in publishing an editorial rejecting the need for boosters in healthy people. The scientists said studies show the shots are working well.
On Friday, U.S. Surgeon General Dr. Vivek Murthy said the Biden administration announcement was not aimed at pressuring regulators to act but was instead an attempt to be transparent with the public and be prepared in the event that boosters won approval.
“We have always said that this initial plan would be contingent on the FDA and the CDC’s independent evaluation,” Murthy said.
The Biden plan has also raised major ethical concerns about impoverished parts of the world still clamoring for vaccine. But the administration argued that the plan was not an us-or-them choice, noting that the U.S. is supplying large quantities of vaccine to the rest of the globe.
The U.S. has already approved Pfizer and Moderna boosters for certain people with weakened immune systems, such as cancer patients and transplant recipients.
Some Americans, healthy or not, have managed to get boosters, in some cases simply by showing up and asking for a shot. And some health systems already are offering extra doses to high-risk people.
The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.
Copyright 2021 The Associated Press. All rights reserved.
'You'll see': Quebec health minister promises bold proposals to solve critical nurse shortage – CTV News Montreal
QUEBEC CITY —
Quebec Health Minister Christian Dube is promising a plan with bold and original ideas to try to attract thousands of nurses back to the public health network and prevent a breakdown of services.
On Friday, during a scrum with journalists in Lévis, Minister Dube reaffirmed his commitment to doing everything possible to offer nurses a more attractive work environment, different from what they’ve known until now, to convince them to return to the public system.
For years, nurses have complained about the widespread practice of demanding mandatory overtime, which regularly forces them to work exhausting double shifts.
The magnitude of the current crisis, with a shortage of over 4,000 nurses keeping the network from functioning normally, is now pushing the Legault government to pay closer attention to their grievances.
Minister Dube promised to announce new incentives next week, both financial and professional, that he believes will bring back nurses who have opted for early retirement in recent years or who have chosen to practice in the private sector.
He intends to be bold in the way he goes about it, he said.
“You’ll see,” said the minister.
“We’re going to make announcements that might have surprised us a few months or a few years ago, but which will be prompted by the fact that we’ve looked at new ways of doing things with the pandemic.”
While he waits for nurses’ reaction to these soon-to-be-announced short-term incentives, Dube is also planning to implement a more long-term, global reorganization, he said, with “much more structural proposals on the table.”
The day before, the minister had pledged to prevent any service disruptions in the health network, despite the significant shortage of personnel.
He’s also contending with the likelihood the problem will worsen as of October 15, the date by which all health-care staff in Quebec will have to be double vaccinated against COVID-19 to stay on the job.
Those who don’t comply will be suspended without pay for an indefinite period. It’s a scenario that suggests the situation will become even more difficult to manage, as there are an estimated 20,000 unvaccinated employees in the network, at least half of whom provide direct patient care.
This report by The Canadian Press was first published in French on Sept. 17, 2021.
COVID-19 booster debate in US heads to FDA vaccine advisory committee – National | Globalnews.ca – Global News
The debate over whether Americans should receive a booster dose of the Pfizer/BioNTech COVID-19 vaccine moves to a panel of independent expert advisers to the U.S. Food and Drug Administration on Friday.
While U.S. health officials, some other countries and vaccine makers have said boosters are needed, many scientists and vaccine experts disagree.
The FDA staff said in documents prepared for the committee this week that the vaccine Pfizer Inc developed with Germany’s BioNTech SE is still very effective at preventing severe illness and death and that the evidence is mixed on whether its efficacy declines over time.
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Pfizer, which is arguing for broad use of a third shot, submitted data from an analysis of over 300 participants in its late stage clinical trial showing that the vaccine’s efficacy diminished by around 6% every two months after the second dose, and that an additional shot boosted immunity.
The FDA’s Vaccines and Related Biological Products Advisory Committee will also consider data from Israel, which has been administering booster doses of the Pfizer/BioNTech vaccine.
It began offering a COVID-19 booster to people as young as age 12 last month, expanding a campaign that began in July for people over 60.
An analysis by Israeli scientists published on Wednesday in the New England Journal of Medicine found that among 1.1 million people age 60 or older who had been fully vaccinated at least 5 months earlier, those who received a booster were less likely to be infected or become severely ill than those who did not get the third shot.
The Israeli Health Ministry said in documents on Friday that immunity against infection declined during July among all age groups, but particularly among people aged 60 and over who had been vaccinated in January.
Immunity against severe disease dropped in that older group, and such a decline may occur in younger groups aged 50 to 59 as well as 40 to 49, it said. The ministry also said the booster dose did not raise new safety issues.
The booster debate gained urgency as U.S. COVID-19 hospitalizations and deaths surged due to the highly transmissible Delta variant of the virus, mostly among the unvaccinated. But infections among fully vaccinated people have risen and they can spread the virus on occasion, mostly to unvaccinated people.
‘LARGER POPULATIONS MAY TAKE LONGER’
Wall Street analysts see the additional shots ultimately getting approved for a broad population.
“We expect a potential positive FDA support for boosters for elderly ahead of Biden’s rollout, but larger populations may take longer for broad support and approval,” Jefferies analyst Michael Yee said in an email.
Scientists say the strongest evidence for boosters is for older adults and other high risk populations.
“My guess is we are going to end up with a recommendation for booster doses for a certain subpopulation, such as adults older than 65,” said Bill Moss, executive director of the International Vaccine Access Center at the Johns Hopkins Bloomberg School of Public Health.
Immunocompromised offered vaccine booster shot. Who is eligible?
More than 1.9 million Americans have already gotten a booster dose after the government authorized them for people with compromised immune systems, according to the U.S. Centers for Disease Control and Prevention (CDC).
The panel will vote on if safety and effectiveness data support approval of a booster at least 6 months after the second dose for people aged 16 and older. The vote is scheduled for between 2:25 pm ET and 4:45 pm ET.
Eight top health officials in the Biden Administration – including the heads of the FDA and the CDC – said in August they believe booster shots will be needed because emerging data shows that protection against COVID-19 decreases over time.
The U.S. is planning a booster campaign for the week of Sept. 20, contingent on backing by the FDA and CDC.
Moderna Inc has also asked for approval of a booster and released data on Wednesday showing that protection from its vaccine also wanes over time. That is not expected to be discussed at Friday’s meeting.
(Reporting by Manojna Maddipatla and Ankur Banerjee in Bengaluru; Editing by Caroline Humer and Bill Berkrot)
© 2021 Reuters
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