Tag Archives: booster shots

Statins may slightly lower COVID-19 death risk; using a different vaccine as booster may offer more protection

By Nancy Lapid

(Reuters) – The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that have yet to be certified by peer review.

Statins may protect slightly against COVID-19 death

Widely-used statin drugs for lowering cholesterol may be linked to a slightly lower risk of dying from COVID-19, new data suggest. Researchers at Karolinska Institute in Sweden reviewed the medical records of nearly 1 million residents of Stockholm over the age of 45 between March and November 2020, roughly 18% of whom had been prescribed a statin, such as Pfizer Inc’s Lipitor (atorvastatin) and Merck & Co’s Zocor (simvastatin). The people prescribed statins had more risk factors for poor COVID-19 outcomes: they were older, more often male, had more medical conditions, lower education levels and less disposable income. After taking all that into account, statin users were still 12% less likely to have died of COVID-19 during the study period, according to a report published on Thursday in PLOS Medicine. The researchers did not compare outcomes in people who actually got infected with the virus, however. And they only had data on prescriptions – not on whether patients took the medicine as prescribed. A formal clinical trial would be needed to confirm the findings. Still, they conclude, their data “suggest that statin treatment may have a modest preventive therapeutic effect on COVID-19 mortality.”

Boosting with a different vaccine is safe, may be better

People who got Johnson & Johnson’s COVID-19 vaccine as a first shot had a stronger immune response when boosted with vaccines from either Pfizer Inc/BioNTech SE or Moderna Inc, according to a study run by the National Institutes of Health. The trial, which included more than 450 adults who received initial shots from Pfizer/BioNTech, Moderna, or J&J, also showed that “mixing and matching” booster shots using different vaccine technology is safe in adults, the researchers reported in a paper posted on medRxiv on Wednesday ahead of peer review. Moderna’s and Pfizer’s vaccines are based on messenger RNA (mRNA) while J&J’s uses viral vector technology. The trial looked at a total of nine combinations of initial shots and boosters. Using different types of shots as boosters generally produced a comparable or higher antibody response than using the same type, the researchers reported. Mixing booster doses “may offer immunological advantages to optimize the breadth and longevity of protection achieved with currently available vaccines,” they said.

Old age alone does not predict COVID-19 mortality risk

Older patients are known to be at higher risk for poor outcomes after infection with the coronavirus, but among those hospitalized with COVID-19, other characteristics help predict who is likely to do poorly, new data suggest. In a review of data on 4,783 people age 65 and older who were hospitalized for COVID-19 early in the pandemic, researchers at Northwell Health hospitals in New York found that age itself did not independently predict whether a patient was more likely to die. Instead, they reported on Thursday in BMC Geriatrics, more important predictors of death for elderly patients were factors such as how independent they were before the infection, how sick they were when they arrived at the hospital, and their pre-existing medical conditions, such as high blood pressure, kidney disease, lung disease and dementia. The researchers noted that in facilities forced to ration care or facing resource shortages, some guidelines use advanced age as a reason to deny care. “Our findings support the American Geriatrics Society position statement indicating age alone should never be used to make decisions regarding resource allocation under conditions of resource scarcity,” the researchers said. “Although age is still an important factor in the overall risk of COVID-19 mortality… a comprehensive approach that accounts for the above factors is essential in preventing ageism.”

(Reporting by Nancy Lapid and Carl O’Donnell; Editing by Bill Berkrot)

U.S. to begin offering COVID-19 vaccine booster shots in September

By Carl O’Donnell and Ahmed Aboulenein

(Reuters) -The U.S. government said on Wednesday it plans to make COVID-19 vaccine booster shots widely available starting on Sept. 20 as infections rise from the coronavirus Delta variant, citing data indicating diminishing protection from the vaccines over time.

U.S. officials are prepared to offer a third shot to Americans who completed their initial inoculation in two-dose COVID-19 vaccines made by Moderna Inc and by Pfizer Inc and BioNTech AG at least eight months ago, the Department of Health and Human Services said in a statement.

Initial booster doses will be given to Americans who received the two-dose vaccines, but U.S. health officials said they anticipate that people who received the single-dose Johnson & Johnson shot, the other COVID-19 vaccine approved in the United States, will also need boosters. The United States did not begin administering J&J shots until March.

The booster shots initially will focus upon healthcare workers, nursing home residents and older people, among the first groups to be vaccinated in late 2020 and early 2021, top U.S. health officials said in a joint statement.

There is mounting evidence that protection from the vaccines wanes after six or more months, particularly in older people with underlying health conditions. The officials cited this in their decision on boosters, but stressed that the U.S.-approved shots have proven “remarkably effective” in reducing the risk of severe disease, hospitalizations and deaths.

The officials included President Joe Biden’s chief medical adviser Anthony Fauci as well as the heads of the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA) and the National Institutes of Health.

“The available data make very clear that protection against SARS-CoV-2 infection begins to decrease over time … and in association with the dominance of the Delta variant, we are starting to see evidence of reduced protection against mild and moderate disease,” the officials said.

“We conclude that a booster shot will be needed to maximize vaccine-induced protection and prolong its durability,” they added.

U.S. officials previously authorized a third dose of the vaccines from Pfizer/BioNTech and Moderna for people with weak immune systems.

In recent weeks, several other countries also have decided to offer booster shots to older adults as well as people with weak immune systems, including Israel, France and Germany.

DELTA VARIANT CONCERNS

Vaccinations have been widely available in the United States, unlike many other countries, but the highly infectious Delta variant has caused what experts describe as a pandemic of the unvaccinated as a significant number of people choose not to get inoculated.

The United States leads the world in reported COVID-19 cases and deaths. Daily U.S. cases soared from fewer than 10,000 in early July to more than 150,000 in August as the Delta variant took hold. The new cases include some vaccinated people, though they are far less likely to experience severe disease or death than the unvaccinated.

According to CDC data, more than 72% of Americans 18 and older have received at least one vaccine dose and nearly 62% are fully vaccinated. Of the total population, the CDC said 59.9% have received at least one dose and 50.9% are fully vaccinated.

More than a million Americans independently sought an extra vaccine dose before the official decision on boosters was announced, according to federal data.

A study by an Israeli healthcare provider released on Wednesday found that a third dose of the Pfizer/BioNTech shot is 86% effective in people over age 60.

It followed another Israeli study released this week that showed evidence of waning immunity from COVID-19 vaccines in the months after inoculation, raising the risk of serious infection among the elderly and people with compromised immune systems.

“The surprise factor is the vaccine vulnerability – people who are vaccinated became vulnerable much earlier than expected,” Dr. Eric Topol, a cardiologist and director of the Scripps Research Translational Institute in California, said about the study.

“The whole dynamic of boosters is being rewritten,” Topol added.

The U.S. announcement goes against guidance from the World Health Organization, whose chief scientist said on Wednesday current data does not indicate the need for booster shots. A WHO adviser said vaccine doses should first go to people in poorer countries who have not yet received an initial inoculation.

The decision represented a shift from the optimism of U.S. health authorities in May in curbing the pandemic when Biden set a goal to vaccinate 70% of American adults with at least one dose by July 4. That goal was achieved about a month late.

The U.S. booster plan is dependent on the FDA determining that a third dose of the two-dose vaccines is safe and effective, and a favorable recommendation from CDC advisers.

(Reporting by Carl O’Donnell in New York and Ahmed Aboulenein in Washington; Editing by Will Dunham and Grant McCool)

Factbox-Latest on the worldwide spread of the coronavirus

(Reuters) – Drugmakers Pfizer, BioNTech and Moderna are expected to make billions of dollars from COVID-19 booster shots in a market that could for years rival the $6 billion in annual sales for flu vaccines, analysts and healthcare investors say.

DEATHS AND INFECTIONS

EUROPE

* The German government has designated the Israel, Turkey and the United States as high-risk countries, triggering a minimum five-day quarantine requirement for those who are unvaccinated, the Funke media group reported.

* Russia reported a record 815 coronavirus-related deaths in the last 24 hours, but Moscow’s mayor said hospitalizations from the disease in the capital had halved over the last six weeks.

* Norway’s government will end some restrictions related to the pandemic, it said, but stopped short of announcing a full reopening of the economy.

ASIA-PACIFIC

* Indonesia’s capital reopened its retail malls this week to an exclusive crowd – shoppers vaccinated against coronavirus.

* China reported declining numbers of new locally transmitted cases for the third consecutive day. However, ports and shipping companies are diverting vessels from a container terminal in the country’s busiest marine transportation hub, which was forced to close after a case emerged.

* Japanese Prime Minister Yoshihide Suga urged people to refrain from travelling as COVID-19 cases spiked to records in Tokyo and nationwide, heaping pressure on the medical system.

* South Korea signed a deal to buy 30 million doses of Pfizer vaccine for 2022, and the government urged people to cut holiday travel amid a worsening fourth wave of infections and a slow inoculation campaign.

AMERICAS

* The U.S. Food and Drug Administration authorized a third dose of vaccines from Pfizer and Moderna for people with compromised immune systems.

* The United States has started shipping nearly 569,000 Pfizer vaccine doses to member countries of the Caribbean Community (CARICOM), the U.S. State Department said.

MIDDLE EAST AND AFRICA

* Morocco received a shipment of 600,000 doses of the Pfizer-BioNTech vaccine as it expands its inoculation campaign to younger people following a surge in cases, said Said Afif, a member of the health ministry’s scientific committee.

* South Africa’s health minister Joe Phaahla said authorities would not would recommend a relaxation of lockdown measures from its current Level 3, despite an overall downward trend in infections as the country grapples with a third wave.

* Israel lowered to 50 from 60 the minimum age of eligibility for a vaccine booster shot and will also offer it to health workers, hoping to stem a surge in Delta variant infections.

MEDICAL DEVELOPMENTS

* The World Health Organization said it was setting up a new group to trace the origins of the coronavirus, seeking to end what it called “political point scoring” that had hampered investigations.

* Indian vaccine maker Bharat Biotech’s nasal vaccine candidate has received regulatory approval for mid- to late-stage trials, the government’s ministry of science and technology said in a statement.

* A two-dose vaccine from China’s Sinopharm was 50.4% effective in preventing infections in health workers in Peru when it saw a surge in cases fueled by virus variants, and booster shots can be considered, a study found.

ECONOMIC IMPACT

* Global stock markets hit record highs on Friday, capping another bumper week as investors seized on a dip in U.S. inflation and more forecast-beating corporate earnings.

(Compiled by Veronica Snoj and Federico Maccioni; Editing by Shounak Dasgupta and Barbara Lewis)

BioNTech says vaccine repeats beat devising new one for now

By Ludwig Burger

FRANKFURT (Reuters) -BioNTech said that repeat shots of its COVID-19 vaccine, of which more than a billion doses have now been supplied worldwide, was a better strategy than tailoring the product it developed with Pfizer to new variants.

The German biotech firm said that offering a third dose of its established two-shot vaccine remained the best response to concerns over waning immune protection in the face of the highly contagious Delta variant, as worse strains may emerge.

BioNTech said the more than one billion supply tally as per July 21 was up from 700 million-plus doses it announced in June.

This compares with AstraZeneca saying last month that it and manufacturing partner Serum Institute of India had supplied a billion doses of its vaccine globally.

Based on delivery contracts signed for more than 2.2 billion doses so far, BioNTech said in a statement detailing its second quarter earnings that it expects to accrue 15.9 billion euros ($18.7 billion) in revenue from the vaccine this year, up from a May forecast of 12.4 billion euros.

That includes sales, milestone payments and a share of gross profit in its partners’ territories, BioNTech added.

Pfizer late last month raised its forecast for its share of 2021 vaccine sales to $33.5 billion and said at the time it believes people will need a third dose of the shot.

Pfizer and BioNTech’s decision in early July to seek authorization for a third dose drew criticism from U.S. health regulators, who said there was not yet enough data to show booster shots are needed.

U.S. health agencies have since discussed additional doses for people with compromised immune systems, while Germany and France said they would roll out a third dose for the most vulnerable from September.

That jars with a call by the World Health Organization to use doses instead to jump-start vaccination campaigns in poorer nations which have so far been left behind.

BioNTech Chief Executive Ugur Sahin said that although work was ongoing to adjust the vaccine to variants it was not clear whether yet another version of the pathogen would supplant the now prevalent Delta variant.

“Making a decision at the moment might turn out to be wrong in three or six months if another variant is dominating,” Sahin said during an analyst call.

Chief Medical Officer Oezlem Tuereci said lab experiments had shown that a third shot of the established product generated neutralizing antibodies against a range of strains and that the antibody boost was above the one following a second dose.

Still, the company reiterated plans to start testing a vaccine adjusted to the Delta variant on humans this month, part of a “comprehensive strategy to address variants.”

($1 = 0.8509 euros)

(Reporting by Ludwig BurgerEditing by Chizu Nomiyama and Alexander Smith)

U.S. plans to give extra COVID-19 shots to at-risk Americans – Fauci

By Trevor Hunnicutt and Carl O’Donnell

WASHINGTON (Reuters) – The United States is working to give additional COVID-19 booster shots to Americans with compromised immune systems as quickly as possible, as cases of the novel coronavirus continue to rise, top U.S. infectious disease expert Dr. Anthony Fauci said Thursday.

The United States is joining Germany, France and Israel in giving booster shots, ignoring a plea by the World Health Organization to hold off until more people around the world can get their first shot.

U.S. regulators need to fully authorize the COVID-19 vaccines or amend their emergency use authorizations before officials can recommend additional shots, but the U.S. Centers for Disease Control and Prevention is working to make third doses available sooner under certain circumstances, officials said at a July meeting.

“It is extremely important for us to move to get those individuals their boosters and we are now working on that,” Fauci said on a press call, adding that immunocompromised people may not be sufficiently protected by their existing COVID-19 vaccinations.

Fauci said rising cases resulting from the spread of the contagious Delta variant in the United States can be turned around with additional vaccinations.

The Biden administration has been eager to thaw opposition by some Americans, including those who distrust the government, to taking the vaccine as the highly infectious Delta variant sweeps the country.

Seven U.S. states with the lowest COVID-19 vaccination rates account for half of the country’s new cases and hospitalizations in the last week, the White House said on Thursday.

The states are Florida, Texas, Missouri, Arkansas, Louisiana, Alabama and Mississippi, according to President Joe Biden’s COVID-19 coordinator, Jeff Zients, who spoke at the press briefing

Of those, Florida and Texas account for about a third of new coronavirus cases and an even higher share of hospitalizations in the country.

COVID cases are up about 43% over the previous week and daily deaths are up more than 39%, according to U.S. Centers for Disease Control and Prevention Director Dr. Rochelle Walensky, who also spoke on the call.

The United States hit a six-month high for new COVID cases with over 100,000 infections reported on Wednesday, according to a Reuters tally.

Some 864,000 vaccinations have been given in the past 24 hours, the highest since early July, the White House said.

Zients said the Biden administration supports U.S. businesses and other institutions requiring that their employees get vaccinated.

He added that the White House is considering requiring foreign visitors to be vaccinated as it plans to eventually reopen international travel but said it had made no final decision.

(Reporting by Jeff Mason, Susan Heavey, Carl O’Donnell and Trevor Hunnicutt; editing by Jonathan Oatis and Lisa Shumaker)

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)

Governments support AstraZeneca shot after South Africa halts roll-out

By Guy Faulconbridge and Kate Holton

LONDON (Reuters) – Western governments rushed to offer support for the AstraZeneca COVID-19 vaccination after South Africa halted its roll-out when research showed it offered minimal protection against mild infection from a variant spreading there.

The arrival of vaccines has given hope that scientists can tame a pandemic that has killed 2.3 million people worldwide. But if vaccines are less effective against new variants, they may need to be tweaked and people may need booster shots.

South Africa announced its pause after researchers from the University of Witwatersrand and the University of Oxford found that the AstraZeneca vaccine provided only minimal protection against mild or moderate infection from the B.1.351 variant, now the dominant form of the virus in that country.

The research is not yet peer reviewed and did not provide data on older people most likely to die or need hospitalization. There was no data on whether the vaccine would prevent severe illness, and researchers said that was still possible.

“This study confirms that the pandemic coronavirus will find ways to continue to spread in vaccinated populations, as expected,” said Andrew Pollard, chief investigator on the Oxford vaccine trial.

“But, taken with the promising results from other studies in South Africa using a similar viral vector, vaccines may continue to ease the toll on health care systems by preventing severe disease.”

SERIOUS INFECTIONS

French Health Minister Olivier Veran voiced support for the AstraZeneca vaccine, arguing it provided sufficient protection against “nearly all the variants” of the virus.

German Health Minister Jens Spahn said current evidence suggests all three vaccines approved in Europe – which include AstraZeneca – provided effective protection against serious infections.

Britain and Australia urged calm, citing evidence that the vaccines prevented grave illness and death, while AstraZeneca said it believed its vaccine could protect against severe disease.

“We think that both the vaccines that we’re currently using are effective in, as I say, in stopping serious disease and death,” British Prime Minister Boris Johnson told reporters. Britain also uses the Pfizer shot.

“We also think in particular in the case of the Oxford AstraZeneca vaccine that there’s good evidence that it is stopping transmission, as well, I think 67% reduction in transmission.”

Australia is expected approve the use of the AstraZeneca vaccine within days and expressed confidence in it.

“There is currently no evidence to indicate a reduction in the effectiveness of either the AstraZeneca or Pfizer vaccines in preventing severe disease and death. That is the fundamental task, to protect the health,” Health Minister Greg Hunt said.

But if vaccines do not work as effectively as hoped against new and emerging variants, then the world could be facing a much longer – and more expensive – battle against the virus than previously thought.

The AstraZeneca vaccine was the big hope for Africa as it is cheap and easy to store and transport. South Africa, which had hoped to roll out the AstraZeneca shot this month, is storing around 1 million doses it has received from the Serum Institute of India.

The B.1.351 variant dominant in South Africa, also known as 20I/501Y.V2, is also circulating in at least 40 other countries, including the United States. Other major variants include one first found in Britain, known as 20I/501Y.V1, and one found in Brazil known as P.1.

Austria warned against non-essential travel to its Alpine province of Tyrol because of an outbreak of the South African variant there. Cases were also detected north of Paris, forcing one school to close.

VACCINE SHOCK

An analysis of infections by the South African variant showed there was only a 22% lower risk of developing mild-to-moderate COVID-19, more than 14 days after being vaccinated with the AstraZeneca shot, versus those given a placebo.

Protection against moderate-severe disease, hospitalization or death could not be assessed in the study of around 2,000 volunteers who had a median age of 31, as the target population were at such low risk.

Professor Shabir Madhi, lead investigator on the AstraZeneca trial in South Africa, said the vaccine’s similarity to another produced by Johnson & Johnson, which reduced severe disease by 85%, suggested it would still prevent serious illness or death.

“There’s still some hope that the AstraZeneca vaccine might well perform as well as the Johnson & Johnson vaccine in a different age group demographic that I address of severe disease,” he told BBC radio.

Sarah Gilbert, professor of vaccinology at the University of Oxford, said efforts were under way to develop a new generation of booster shot vaccines that will allow protection against emerging variants.

“This is the same issue that is faced by all of the vaccine developers, and we will continue to monitor the emergence of new variants that arise in readiness for a future strain change.”

(Reporting by Guy Faulconbridge and Kate Holton; editing by Michael Holden, Angus MacSwan, Nick Macfie and Giles Elgood)