Tag Archives: Vaccine

Over 900,000 U.S. kids to get first COVID-19 shot by end of Wed -White House

WASHINGTON (Reuters) -Over 900,000 U.S. children aged 5-11 are expected to have received their first COVID-19 vaccine shot by the end of Wednesday, White House COVID-19 coordinator Jeff Zients said, as the government ramped up vaccinations of younger children.

The United States on Wednesday began administering Pfizer/BioNTech’s COVID-19 vaccine to children ages 5 to 11, the latest group to become eligible for the shots that provide protection against the illness to recipients and those around them.

“While our program is just fully up and running this week, by the end of the day today, we estimate that over 900,000 kids aged five through 11 will have already gotten their first shot,” Zients said during a briefing with reporters.

The figure comes from a White House analysis of available data from pharmaceutical partners, some states, and localities, Zients said, adding the CDC has not yet collected the full tally.

COVID-19 is the largest vaccine-preventable killer of children in that age group, with 66 children dying from it over the past year, U.S. Centers for Disease Control and Prevention Director Dr. Rochelle Walensky said at the same briefing.

The seven-day average of total COVID-19 cases in the U.S. was flat at about 73,300 over the past week, she said, with the hospitalization rate also flat at 5,000 a day. The seven-day average of daily deaths fell 11% to around 1,000 per day.

(Reporting by Susan Heavey, Alexandra Alper, and Ahmed Aboulenein; Editing by Nick Zieminski and David Gregorio)

Factbox – Latest on the worldwide spread of the coronavirus

(Reuters) – New York City Mayor Bill de Blasio declared his coronavirus vaccination order for emergency responders a success, with no disruption to city services, despite a sickout by some firefighters who officials said were protesting the mandate.

DEATHS AND INFECTIONS

EUROPE

* Leaders of the world’s 20 biggest economies endorsed in Rome a global minimum tax aimed at stopping big business from hiding profits in tax havens, and also agreed to get more COVID vaccines to poorer nations.

* Britain will send 20 million vaccine doses to developing countries by the end of this year in what Prime Minister Boris Johnson will tell other world leaders is a much needed step to speed up the post-pandemic economic recovery.

* President Vladimir Putin said Russia may need the army’s help to build field hospitals for COVID-19 patients as the country battles a surge in infections that has led to a nationwide workplace shutdown.

* The Netherlands will impose new coronavirus restrictions this week in a bid to curb a recent surge in infections.

* Latvia has received shipments of emergency medical equipment from the Netherlands, Finland, Hungary and Sweden as it fights the worst surge in new COVID-19 cases in the European Union amid a low take-up of vaccinations.

AMERICAS

* The Biden administration said a planned rule requiring private-sector employers with 100 or more employees to mandate COVID-19 vaccines or regular testing will be published in the coming days.

* The United States is rolling out Pfizer/BioNTech COVID-19 vaccines for children aged 5 to 11 this week, but most of the 15 million shots being shipped initially are unlikely to be available before next week.

* U.S. states with the highest adult vaccination rates against COVID-19 are planning a big push to get children inoculated compared to states where hesitancy remains strong, potentially widening the gaps in protection nationwide, public health officials and experts said.

ASIA-PACIFIC

* Thailand, Australia and Israel eased international border restrictions significantly Monday for the first time in 18 months, offering a broad test of demand for travel worldwide amid the pandemic.

* New Zealand will extend coronavirus curbs for another week in its largest city of Auckland but ease some after that, with the country logging another day of record new infections.

* A declassified U.S. intelligence report saying it was plausible that the COVID-19 pandemic originated in a laboratory is unscientific and has no credibility, a Chinese foreign ministry spokesman said.

* Indonesia has approved the Sinovac Biotech vaccine for children aged 6-11, its food and drug agency said, following the U.S. Food and Drug Administration’s approval of the Pfizer/BioNTech vaccine for younger children.

MIDDLE EAST AND AFRICA

* The United Arab Emirates has approved for emergency use the Pfizer-BioNtech vaccine for children aged 5-11, the health ministry said in a statement carried by state media.

MEDICAL DEVELOPMENTS

* Novavax Inc expects regulators in India, the Philippines and elsewhere to make a decision on its COVID-19 vaccine within “weeks,” its chief executive told Reuters, after the shot received its first emergency use authorization from Indonesia.

ECONOMIC IMPACT

* Global equity markets rose at the start of a big week for central bank meetings, helped by bets of fiscal stimulus in Japan and undeterred by concerns of future interest rate hikes that have tempered bonds.

(Compiled by Aditya Soni and Federico Maccioni; Edited by Angus MacSwan and Arun Koyyur)

Cuba to welcome tourists as home-grown vaccine drive takes hold

By Marc Frank and Nelson Acosta

HAVANA (Reuters) – Cuba will open its borders and ease entry requirements next month after vaccinating most of its people with home-grown COVID-19 drugs, allowing it to welcome back overseas visitors and giving a shot in the arm to its ailing tourist industry.

Tough restrictions due to the pandemic, a drastic reduction in flights to Cuba, and a U.S. ban on most travel to the Communist-run island under former U.S. President Donald Trump have hobbled the business and left it trailing behind regional competitors such as the Dominican Republic, Puerto Rico, the Bahamas and Cancun.

But as Nov. 15, Cuba will only require visitors to carry proof of vaccination or a recent PCR to enter the country, replacing what were previously among the strictest protocols in the Caribbean, involving a quarantine period and multiple PCR tests.

A fully vaccinated population will prove a key selling point for an island already well-regarded for its safety, beaches and turquoise waters, said Francisco Camps, who supervises Spanish firm Sol Melia’s 32 hotels in Cuba.

“Cuba will be one of the safest sanitary destinations and we believe that we can reach visitations similar to 2019 by the end of next year,” he said.

Cuba’s home-grown vaccines are currently under review by the World Health Organization and most trial data has yet to be peer reviewed.

But among countries with more than 1 million people, Cuba is vaccinating faster than any other, according to a Reuters tally of official data.

The government says the pace is paying dividends, with COVID-19 cases and deaths falling off at least 80% since their peak mid-summer. At least 90% of the population has received at least one dose of one of the country’s three-dose homegrown vaccines.

“We are in a favorable moment as we begin to recover our customs, to be able to visit relatives and go on vacation, as well as improve economic activity,” Tourism Minister Juan Carlos Garcia said this month.

The pandemic closed schools, entertainment venues and restaurants as it reduced to near zero the all-important tourism industry – freezing foreign trips by Cubans and visits to the country from Cubans living overseas – exacerbating an economic crisis that has left residents short of food and medicine.

Cuba received more than four million tourists in 2019, contributing 10.6 percent to gross domestic product (GDP), and much more through supply chains and informal economic activity.

But this year just 200,000 guests have arrived and only another 100,000 are expected, Minister Garcia said.

Cuban economist Ricardo Torres said those numbers meant a “devastating” 92% drop in tourism this year, compared to 2019.

“So we are talking about next year for any real tourism recovery…which generates a knock-on effect and so is decisive to economic recovery,” said Torres, a visiting professor at American University in Washington.

The U.S. embargo sharply limits trade with Cuba, so the country depends heavily on flows of foreign currency and basic goods that travelers and the Cuban diaspora bring to the island.

Despite mounting optimism as tourism resumes, officials have cautioned economic recovery will be more gradual than initially thought following a sharp drop of 10.9% last year and another 2% through June.

The Varadero beach resort is already partially open, including for the domestic market, for which it is the favorite destination.

And life is slowly returning to the colonial district of Havana as it prepares to once more welcome visitors after a 19-month hiatus.

“Old Havana has been sad all this time because there have been no tourists,” said Ernesto Alejandro Labrada, owner of the Antojos restaurant, now packed with Cubans enjoying a meal before the visitors return.

(Reporting by Marc Frank; additional reporting by Nelson Acosta, editing by Dave Sherwood and Angus MacSwan)

U.S. FDA advisers weigh Pfizer/BioNTech COVID-19 vaccine in children

By Manas Mishra and Michael Erman

(Reuters) -An expert panel will weigh authorization of Pfizer Inc and BioNTech’s COVID-19 vaccine for U.S. children aged 5 to 11 on Tuesday as it prepares to vote on a recommendation for the federal Food and Drug Administration.

An authorization is an important regulatory step toward reaching about 28 million children of these ages, most of them back in school for in-person learning.

The FDA need not follow the advice of its outside experts, but usually does.

While children rarely become seriously ill or die from COVID-19, some develop complications, and COVID-19 cases in unvaccinated children have risen due to the contagious Delta variant.

The age group is “far from being spared from the harm of COVID-19,” with the virus now one of the top 10 causes of deaths in American children, FDA official Peter Marks told the panel. He said there had been close to 100 deaths in that age group so far, and 1.9 million infections.

“In addition, infections have caused many school closures and disrupted the education and socialization of children,” he said.

FDA staff, in documents posted before the meeting, said the likely vaccine benefits in that age group clearly outweigh the potential harms, including the rare risk of heart inflammation.

Only a few other countries, including China, Cuba and the United Arab Emirates, have cleared COVID-19 vaccines for children in this age group and younger.

Since May, the World Health Organization has been urging rich countries to reconsider plans to vaccinate children and instead donate COVID-19 shots to the COVAX scheme for poorer countries.

The advisers are expected to pay close attention to the rate of the rare cases of heart inflammation called myocarditis that have been linked to both the Pfizer/BioNTech and Moderna vaccine, particularly in young men.

Pfizer and BioNTech are seeking clearance for a lower, 10-microgram dose version of the vaccine in children, versus 30 micrograms for everyone over the age of 12. The shot has been authorized for ages 12-15 since May and cleared for everyone over 16 since December.

The companies have said their vaccine showed 90.7% efficacy against the coronavirus in a clinical trial of children aged 5 to 11.

After the FDA, a panel to the U.S. Centers for Disease Control and Prevention will make a recommendation on the administration of the vaccine. The director of the agency will make the final call.

Top U.S. infectious disease expert Anthony Fauci said on Sunday that it was likely the vaccine will be available to children in the first week or two of November.

If the number of myocarditis cases in the younger age group turns out to be similar to that in 12- to 15-year-olds, the hospitalizations prevented for COVID-19 would outnumber those prevented for myocarditis in most scenarios analyzed, FDA staff reviewers said.

“No matter what size of the safety database, there will always be uncertainties regarding benefits and risks, including for example, the risk of vaccine-associated myocarditis,” said Doran Fink, the FDA’s deputy director for vaccine development.

These uncertainties have to be addressed in surveillance data and studies following authorization, Fink told the panel.

Pediatric vaccinations are an important public health tool to prevent infectious diseases, even ones that do not cause high rates of mortality or hospitalization for children.

(Reporting by Manas Mishra in Bengaluru and Michael Erman in New Jersey; Editing by Caroline Humer, Richard Chang and Jonathan Oatis)

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)

New York must allow religious exemptions to COVID-19 vaccine mandate, judge rules

By Tom Hals and Nate Raymond

(Reuters) -A federal judge ruled on Tuesday that New York state cannot impose a COVID-19 vaccine mandate on healthcare workers without allowing their employers to consider religious exemption requests.

U.S. District Judge David Hurd in Albany, New York, ruled that the state’s workplace vaccination requirement conflicted with healthcare workers’ federally protected right to seek religious accommodations from their employers.

The ruling provides a test case as vaccine mandate opponents gear up to fight plans by President Joe Biden’s administration to extend COVID-19 inoculation requirements to tens of millions of unvaccinated Americans.

Vaccines have become highly politicized in the United States, where only 66% of Americans are vaccinated, well short of the initial goals of the Biden administration.

Seventeen healthcare workers opposed to the mandate sued, saying the requirement violated their rights under the U.S. Constitution and a federal civil rights law requiring employers to reasonably accommodate employees’ religious beliefs.

Hurd agreed, saying the state’s order “clearly” conflicted with their right to seek religious accommodations.

“The court rightly recognized that yesterday’s ‘front line heroes’ in dealing with COVID cannot suddenly be treated as disease-carrying villains and kicked to the curb by the command of a state health bureaucracy,” said Christopher Ferrara, a lawyer for the workers at the conservative Thomas More Society.

New York Governor Kathy Hochul, a Democrat, vowed in a statement to fight the decision, saying her “responsibility as governor is to protect the people of this state, and requiring health care workers to get vaccinated accomplishes that.”

At least 24 states have imposed vaccine requirements on workers, usually in healthcare.

New York’s Department of Health on Aug. 26 ordered healthcare professionals to be vaccinated by Sept. 27 and the order did not allow for the customary religious exemptions.

Hurd issued a temporary restraining order on Sept. 14 in favor of the workers while he considered whether to issue a preliminary injunction.

(Reporting by Tom Hals in Wilmington, Delaware and Nate Raymond in Boston; Editing by Noeleen Walder and Peter Cooney)

Pfizer study to vaccinate whole Brazilian town against COVID-19

BRASILIA (Reuters) -Pfizer Inc will study the effectiveness of its vaccine against COVID-19 by inoculating the whole population over the age of 12 in a town in southern Brazil, the company said on Wednesday.

The study will be conducted in Toledo, population 143,000, in the west of Parana state, together with Brazil’s National Vaccination Program, local health authorities, a hospital and a federal university.

Pfizer said the purpose was to study transmission of the coronavirus in a “real-life scenario” after the population has been vaccinated.

“The initiative is the first and only of its kind to be undertaken in collaboration with the pharmaceutical company in a developing country,” Pfizer said.

A similar study was conducted by the Butantan Institute, one of Brazil’s leading biomedical research centers, in the smaller town of Serrana, in Sao Paulo state, to test the CoronaVac shot developed by China’s Sinovac Biotech Ltd.

In May, Butantan said mass vaccination had reduced COVID-19 death by 95% in the town with a population of 45,644 people. The institute is considering extending the study for a third dose.

“Here we believe in science and we lament the almost 600,000 deaths from COVID-19 in Brazil,” Toledo Mayor Beto Lunitti said at a news conference announcing the Pfizer study.

Regis Goulart, a researcher at Toledo’s Moinhos de Vento Hospital, said its aim was to validate the real-world efficacy and safety of the vaccine seen in clinical trials.

The observational study will also be an opportunity to do long-term monitoring for up to one year of participants and to answer lingering questions such as the duration of vaccine protection against COVID-19 and new variants, Goulart said.

(Reporting by Anthony Boadle; Editing by Jason Neely and Mark Porter)

Genes may add to ethnic COVID-19 disparities; sickest patients unwell a year later

By Nancy Lapid

(Reuters) – Here 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.

Genes may explain some ethnic differences in COVID-19 impact

The varying impacts of COVID-19 among ethnic groups might be partially due to genetic differences in the cell-surface protein the virus uses as a gateway, an international research team found. They analyzed genetic information from more than 85,000 volunteers, including 6,274 who were tested for the new coronavirus and 1,837 who tested positive. In the gene for ACE2 – the “receptor” protein through which the virus breaks into cells – they found rare variants that would alter the part of the protein to which the virus attaches itself. These variant genes “appear to vary in frequency between different ethnic groups,” said Jamal Nasir of the University of Northampton in the UK. Two were more common in Europeans than in East Asians, for example. Nasir and colleagues also found variants that appear to increase or decrease an individual’s ACE2 protein levels, which could affect vulnerability to infection, or severity. People who were not infected with the coronavirus were more likely to have a variant that decreases ACE2 levels, according to a report posted on Wednesday on medRxiv ahead of peer review. The next steps, Nasir said, are to confirm the findings by exposing human cells to the virus in lab experiments and to identify small molecules that can be used as drugs to block harmful genetic mutations’ effects.

Severe COVID-19 still affects patients a year later

Among 1,276 COVID-19 patients hospitalized in China early in the pandemic, 49% still had at least one symptom 12 months after first becoming ill, researchers reported on Friday in The Lancet. Most common were fatigue or muscle weakness. About a third still had shortness of breath or other lung problems, especially those who had been the most severely ill. In some patients, doctors saw a reduced flow of oxygen from the lungs to the bloodstream. Roughly one in four survivors reported depression. Among patients who had been employed before they were hospitalized, 88% had returned to work by 12 months – but overall, the survivors were not as healthy as people from the community who had not been infected with the coronavirus. The study only looked at patients from one hospital, and not many of them had been sick enough to require intensive care. Nevertheless, the fact that some patients still had symptoms “should be taken into account when planning delivery of healthcare services post-pandemic,” coauthor Bin Cao from the China-Japan Friendship Hospital said in a statement.

Pfizer vaccine safe in small study of very sick kids

In adolescents with serious neurological conditions, the side effects of the Pfizer/BioNTech vaccine are likely to be mild to moderate and clear up quickly, a small study suggests. The 27 children in the study, ages 12 to 15, had muscular dystrophy, cerebral palsy, or other neurological diseases, plus other conditions such as heart defects and immune deficiency – all of which put them at very high risk for severe COVID-19. They would not have been included in the main trials of the vaccine because they were too sick, the researchers said. Eleven children had averse events after the first or second dose, such as mild rash, fever, headache, gastrointestinal upset, difficulty sleeping, and low blood sugar. Most problems resolved within 72 hours, and the rest cleared up within a week, according to a report published on Thursday in Archives of Disease in Childhood. Although the study involved only a few children, “these data are especially important as they are representative of the children who are most likely to benefit from vaccination, and parents and clinicians may have concerns regarding an increased risk of unexpected events,” the authors said.

(Reporting by Nancy Lapid; Editing by Tiffany Wu)

Factbox – Latest on the worldwide spread of the coronavirus

(Reuters) – The World Health Organization’s (WHO) pandemic program plans to ship 100 million doses of Sinovac and Sinopharm COVID-19 shots by the end of next month, mostly to Africa and Asia, in its first delivery of Chinese vaccines, a WHO document showed.

EUROPE

* Britain’s Health Department said it has not made any decision on COVID-19 vaccines for 12 to 15-year-olds after the Telegraph reported the National Health Service planned vaccinations from the first week children return to school in September.

* The British public’s view of the government’s management of the coronavirus crisis has turned negative for the first time since February and they are worried about the risk of a new wave of infections, according to a survey.

* Hundreds of Greek frontline health workers protested against a plan to make COVID-19 vaccinations mandatory for the care sector as infection rates remained high.

* Students and teachers who have not been inoculated against COVID-19 or recovered from the disease will have to take weekly tests, as infections in the country rose to their highest since May.

ASIA-PACIFIC

* Vilified by Indian Prime Minister Narendra Modi’s party for its high COVID-19 cases, Kerala’s apparent poor record may actually hold crucial lessons for the country in containing the outbreak as authorities brace for a possible third wave of infections.

* Vietnam will deploy troops to industrial Binh Duong province, a major manufacturing hub in the Southeast Asian country, to help contain an expected 50,000 additional coronavirus infections there over the next two weeks, the government said.

* Thailand is in talks with European countries to purchase millions of doses of COVID-19 vaccines.

AMERICAS

* Illinois will require all eligible students and school employees to be vaccinated and re-instituted an indoor mask mandate under an order announced by Governor J.B. Pritzker.

* Public support for stronger measures to require COVID vaccinations is strong, according to a new Reuters/IPSOS poll, but for Detroit automakers the debate over vaccination policy is far from over.

MIDDLE EAST AND AFRICA

* A third wave of COVID-19 infections in Africa has stabilized and the continent’s slow vaccination drive has picked up pace, the WHO said.

* Qatar is offering COVID-19 vaccines to evacuees from Afghanistan who are temporarily staying in the Gulf Arab state, which has been facilitating global evacuation efforts since the Taliban seized Kabul.

MEDICAL DEVELOPMENTS

* Inovio Pharmaceuticals Inc said it would start a large study for its experimental COVID-19 vaccine in the next few weeks, after the drugmaker received authorization from Brazil’s regulatory agency.

* Pfizer Inc and BioNTech signed on Brazil’s Eurofarma Laboratorios as a manufacturer of their COVID-19 vaccine doses for Latin America.

* Pfizer said a booster dose of its two-shot COVID-19 vaccine spurs a more than threefold increase in antibodies against the coronavirus, as the company seeks U.S. regulatory approval for a third injection.

ECONOMIC IMPACT

* Global equity markets slipped while U.S. Treasury yields rose to two-week highs on Thursday after two hawkish Federal Reserve officials called for the U.S. central bank to start ending its bond-buying program ahead of a key speech by Fed Chair Jerome Powell.

(Compiled by Aditya Soni and Krishna Chandra Eluri; Editing by Subhranshu Sahu and Arun Koyyur)

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)