Factbox: Countries respond to heart inflammation risk from mRNA shots

(Reuters) – Some countries have halted altogether or are giving only one dose of COVID shots based on so-called mRNA technology to teens following reports of possible rare cardiovascular side effects.

Europe’s drug regulator said in July it had found a possible link between a very rare inflammatory heart condition and COVID-19 vaccines from Pfizer/BioNTech and Moderna.

However, the benefits of mRNA shots in preventing COVID-19 continue to outweigh the risks, European and U.S. regulators and the World Health Organization have said.

Here are some of the steps some countries are taking:

CANADA

The Public Health Agency of Canada said data suggested that reported cases of rare heart inflammation were higher after Moderna’s COVID-19 vaccine compared with the Pfizer/BioNTech shots.

SWEDEN

Sweden paused the use of Moderna’s COVID-19 vaccine for younger groups, citing data from a yet unpublished Nordic study.

The Swedish health agency said it would pause using the shot for people born in 1991 and later as data pointed to an increase of myocarditis and pericarditis among youths and young adults that had been vaccinated.

DENMARK

The Danish Health Agency said on Friday that it was continuing to offer Moderna’s COVID-19 vaccine to under-18s, and that a statement on Wednesday suggesting a suspension had in fact been a miscommunication.

FINLAND

Finland paused the use of Moderna’s vaccines for younger people and instead would give Pfizer’s vaccine to men born in 1991 and later. It offers shots to those aged 12 and over.

HONG KONG

A panel of health experts advising the Hong Kong government has recommended in September children aged 12-17 should get only one dose of BioNTech’s COVID-19 vaccine after reports of heart inflammation as a side effect.

NORWAY

Norway is giving one dose of Pfizer/BioNTech vaccine to children aged 12-15.

UNITED KINGDOM

Britain has been offering all 12-15-year-olds a first a shot of the Pfizer/BioNTech vaccine. Second doses would not be offered to the age group until at least spring when there may be more data from around the world.

(Compiled by Antonis Triantafyllou; Editing by Anna Pruchnicka and Tomasz Janowski)

Pfizer, BioNTech seek U.S. COVID-19 vaccine clearance for children 5-11

WASHINGTON (Reuters) -Pfizer Inc and BioNTech SE have asked U.S. regulators to authorize emergency use of their COVID-19 vaccine for children ages 5 to 11, a group for whom no shot is currently allowed, Pfizer said on Thursday.

The U.S. Food and Drug Administration has set a date of Oct. 26 for its panel of outside advisers to meet and discuss the application, making it possible for children in this age group – numbering around 28 million – to begin receiving the two-dose Pfizer/BioNTech vaccine shortly afterward.

“With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against #COVID19,” Pfizer wrote on Twitter.

The vaccine already has won U.S. emergency use authorization in teens ages 12 to 15 and is fully approved by regulators for people ages 16 and up.

The Pfizer/BioNTech vaccine is one of three in use in the United States, along with the two-dose Moderna vaccine and the single-dose Johnson & Johnson version, neither of which has won full regulatory approval for any age group.

A rapid authorization of the Pfizer/BioNTech vaccine in young kids could help mitigate a potential surge of cases in the coming weeks and months, with schools open nationwide and colder weather driving activities indoors. If given regulatory authorization, the two-dose Pfizer/BioNTech vaccine would become the first COVID-19 shot made available to children 5 to 11 in the United States.

The Pfizer/BioNTech vaccine has been shown to induce a strong immune response in 5 to 11 year old’s in a 2,268-participant clinical trial, the companies said on Sept. 20.

The two drugmakers are also testing the vaccine in children ages 2 to 5 years old and children ages 6 months to 2 years, with data expected in the fourth quarter.

The vaccine could be ready for roll out as early as November pending approval from federal regulatory health agencies, White House COVID-19 response coordinator Jeffrey Zients said on CNN.

Once the authorization is granted, Zients said: “We are ready. We have the supply. We’re working with states to set up convenient locations for parents and kids to get vaccinated including pediatricians’ offices and community sites.”

The United States leads the world in COVID-19 cases and deaths.

Children currently make up about 27% of all U.S. coronavirus cases and an increasing percentage of hospitalizations, according to the American Academy of Pediatrics. That reflects the high contagiousness of the coronavirus Delta variant among unvaccinated people.

While children are less susceptible to severe COVID-19, they can spread the virus to others, including vulnerable populations more at risk of severe illness.

A Pfizer spokesperson said the application to the FDA has been completed.

(Reporting by Susan Heavey in Washington and Manas Mishra and Manojna Maddipatla in Bengaluru; Editing by Will Dunham, Timothy Heritage and Saumyadeb Chakrabarty)

U.S. FDA advisers may vote on COVID-19 boosters for older adults after rejecting broad approval

By Manojna Maddipatla and Michael Erman

(Reuters) – A panel of expert outside advisers to the U.S. Food and Drug Administration voted against broadly approving COVID-19 vaccine booster shots, but may vote on a narrower approval for older adults later on Friday.

The panel voted overwhelmingly against approving boosters for Americans age 16 and older, potentially undermining the Biden administration’s plan to roll out third shots of the Pfizer/BioNTech vaccine as soon as next week.

But there was widespread support among panelists for a third dose for older Americans, who are at higher risk of severe COVID-19 and may be more likely to have waning immunity after the first rounds of shots. FDA officials said that a vote to recommend approval for such groups was possible later on Friday.

The FDA will take the panel’s recommendation into consideration in making its decision on the boosters. But it can reject the advice as it did recently in approving Biogen Inc’s controversial Alzheimer’s drug

Many committee members were critical of the booster plan, arguing that the data presented by Pfizer and the FDA was incomplete and that the request for approval for people as young 16 is too broad. Most of them said they were not needed yet for younger adults.

Top FDA members have been split on the necessity of the boosters, with interim head Janet Woodcock backing them and some of the agency’s top scientists arguing they are not needed yet.

If the FDA goes ahead and approves the booster, a separate panel advising the U.S. Centers for Disease Control and Prevention (CDC) will meet next week to recommend which groups should get them.

The White House said it was ready to roll out boosters next week if health officials approve the plan.

(Reporting by Manojna Maddipatla and Ankur Banerjee in Bengaluru, Mike Erman in New York and Julie Steenhuysen in Chicago; Editing by Caroline Humer and Bill Berkrot)

United States buys 200 million more doses of Pfizer/BioNTech COVID-19 vaccine

(Reuters) -Pfizer Inc and German partner BioNTech said on Friday the U.S. government has purchased 200 million additional doses of their COVID-19 vaccine to help with pediatric vaccination as well as possible booster shots – if they are needed.

A Biden administration official with knowledge of the contract said that as part of the agreement, Pfizer will provide the United States with 65 million doses intended for children under 12, including doses available immediately after the vaccine is authorized for that age group.

The U.S. government also has the option to buy an updated version of the vaccine targeting new variants of the virus.

The deal comes as the Delta variant of the coronavirus sweeps across the country and drives up infections, contributing to the debate over whether or not Americans will need a booster dose this fall.

It also follows the government’s move in June to buy 200 million more doses of Moderna Inc’s COVID-19 vaccine.

The purchase brings the total number of doses of the Pfizer/BioNTech vaccine to be supplied to the United States to 500 million, of which roughly 208 million doses have already been delivered, as of Thursday’s data from the government.

“These additional doses will help the U.S. government ensure broad vaccine access into next year,” Pfizer Chief Executive Officer Albert Bourla said in a statement.

Pfizer last year signed a deal with the U.S. government for 100 million doses of the vaccine for nearly $2 billion, with an option to buy 500 million more doses.

A majority of the new doses will be supplied by the end of the year, and the remaining 90 million will be delivered by April 30, the companies said.

Pfizer and BioNTech have designed a new version of their vaccine targeting the Delta variant, which they plan to test in the coming weeks, but have said the current vaccine could also provide protection against the variant.

Pfizer earlier this month said the companies plan to seek authorization from U.S. and European regulators for a booster dose of their COVID-19 vaccine.

The U.S. government has said Americans who have been fully vaccinated do not need a booster COVID-19 shot at this time.

Advisers to the U.S. Centers for Disease Control and Prevention on Thursday considered evidence suggesting that a booster dose of COVID-19 vaccines could increase protection among people with compromised immune systems.

CDC scientists told advisers that boosters for the immunocompromised would need to wait for regulatory action from the U.S. Food and Drug Administration – either full approval of vaccines or amendments to their current emergency use authorizations – before the CDC could make a recommendation.

(Reporting by Manas Mishra in Bengaluru and Michael Erman in New Jersey; Editing by Sriraj Kalluvila, Maju Samuel and Dan Grebler)

Third-trimester vaccination appears safe; Pfizer/BioNtech vaccine effective in those with chronic illnesses

By Nancy Lapid

(Reuters) -The following is a roundup of some of the latest scientific studies on the novel coronavirus and efforts to find treatments and vaccines for COVID-19, the illness caused by the virus.

Third-trimester vaccination appears safe in early data

Among pregnant women who received COVID-19 vaccines manufactured by Pfizer Inc and BioNTech SE or Moderna Inc and who signed up for an online survey, side effects were no different than what has been seen in the general population, researchers reported Wednesday in The New England Journal of Medicine. But they noted that data of this nature is still sparse. They looked at responses from smartphone users who participated in the U.S. Centers for Disease Control and Prevention (CDC) “v-safe” program, which collects information on COVID-19 vaccination experiences. Compared to non-pregnant women, the 35,691 pregnant responders reported more injection site pain but fewer headaches, muscle aches, chills, and fevers. Among 3,958 women who signed up for a CDC pregnancy registry, no one vaccinated in the first trimester has given birth yet. The Vaccine Adverse Event Reporting System (VAERS), run jointly by the CDC and the U.S. Food and Drug Administration, has recorded 46 miscarriages potentially related to COVID-19 vaccination, including 37 in the first trimester, the researchers said. “Early data from the v-safe surveillance system, the v-safe pregnancy registry, and the VAERS do not indicate any obvious safety signals with respect to pregnancy or neonatal outcomes associated with Covid-19 vaccination in the third trimester of pregnancy,” researchers concluded.

Pfizer/BioNTech vaccine effective in people with chronic illnesses

The Pfizer/BioNTech COVID-19 vaccine is effective at preventing symptomatic and severe disease in people with some chronic illnesses, like diabetes and heart disease, according to a large real-world study published on Wednesday in The New England Journal of Medicine. The analysis of almost 1.4 million people, conducted by Clalit, Israel’s largest healthcare provider, showed the vaccine was 80% effective against symptomatic infection for people with heart or chronic kidney diseases, 86% for people with type 2 diabetes, 75% for cerebrovascular disease, and 84% for people suffering from immunodeficiency. For vaccinated people with at least three chronic conditions or risk factors, the vaccine was 88% effective in preventing symptomatic infection. It was more than 90% effective against severe disease for people with type 2 diabetes, heart or cerebrovascular disease. The results were lower than the 95% overall vaccine effectiveness observed after the second dose in clinical trials last year. “These results are very encouraging, as they suggest that most COVID-19 cases will be prevented by vaccination even in the elderly and chronically ill,” said Ran Balicer, Clalit’s chief innovation officer.

Fever, shortness of breath are COVID-19 red flags in pregnancy

Pregnant women with COVID-19 and their newborns face “consistent and substantial increases” in risks of complications, an international study has found. COVID-19 in newborns is associated with a three-fold risk of severe medical complications, according to the study by scientists at the University of Oxford. And pregnant women with symptomatic COVID-19 face higher risks of preterm delivery, preeclampsia (high blood pressure with organ failure risk), need for intensive care and death. That was particularly true for women with fever and shortness of breath, according to a report published on Friday in JAMA Pediatrics. “Women with COVID-19 during pregnancy were over 50% more likely to experience pregnancy complications compared to pregnant women unaffected by COVID-19,” said co-author Aris Papageorghiou. The study, conducted in 18 countries, included 706 pregnant women with COVID-19 and 1,424 similarly pregnant women without COVID-19 who were giving birth at the same hospital. Findings also showed a delivery by Caesarean section may be associated with an increased risk of virus infection in newborns. Breastfeeding, however, does not seem to heighten risks of transmission from mothers to babies, they found.

(Reporting by Nancy Lapid and Maayan Lubell; Editing by Bill Berkrot)

U.S. pauses J&J COVID-19 vaccine over rare blood clots

By Manas Mishra and Michael Erman

(Reuters) – U.S. federal health agencies on Tuesday recommended pausing the use of Johnson & Johnson’s COVID-19 vaccine after six women under 50 developed rare blood clots after receiving the shot, dealing a fresh setback to efforts to tackle the pandemic.

The move comes a week after European regulators said they had found a possible link between AstraZeneca’s COVID-19 vaccine and a similar rare blood clotting problem that led to a small number of deaths.

Johnson & Johnson’s (J&J) single dose vaccine – most COVID-19 shots are delivered over two doses – and AstraZeneca’s low-cost vaccine are seen as vital tools in the fight against a pandemic that has claimed more than three million lives.

Most of the available J&J vaccine has been used in the United States due to production issues that have limited the company’s supply. As of April 12, more than 6.8 million doses of the J&J vaccine had been administered in the United States, compared with more than 180 million shots combined of the Moderna and Pfizer/BioNTech shots.

An advisory committee to the U.S. Centers for Disease Control and Prevention (CDC) will meet on Wednesday to review the cases, and the U.S. Food and Drug Administration (FDA) will review the analysis, the agencies said in a joint statement.

All six cases involved women between the ages of 18 and 48, and the symptoms occurred six to 13 days after vaccination.

In the cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia).

The CDC and FDA said the adverse events appeared to be extremely rare.

“I think this is a very low risk issue, even if causally linked to the vaccine: 6 cases with about 7 million doses (lower than the risk of clots with oral contraceptives) is not something to panic about,” Dr. Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Security in Baltimore, said in an email.

“People are asking me if they should cancel their J&J vaccine appointments and I have told them not to but I know many will and this will stall progress in controlling the pandemic.”

J&J said it was working closely with regulators and noted no clear causal relationship had been established between the cases and the COVID-19 vaccine made by its Janssen unit.

One woman died and a second in Nebraska has been hospitalized in a critical condition, the New York Times reported, citing officials.

‘ABUNDANCE OF CAUTION’

“The FDA recommendation to pause the administration of the Johnson and Johnson vaccine out of an abundance of caution makes sense in terms of the nature of the unusual and serious side effect not seen with the other vaccines,” said Dr. Robert Klugman at the UMass Memorial Medical Center in Massachusetts in an email.

“While the incidence is very low, the severity and potential for brain damage and other blood clot-related injuries is of great concern.”

J&J’s shares were down 3% before the opening bell.

The U.S. move comes less than a week after Europe’s drugs regulator said it was reviewing rare blood clots in four people in the United States who had received the J&J shot.

The J&J and AstraZeneca vaccines both use an adenovirus vector – a harmless cold virus that instructs human cells to produce a protein found on the surface of the coronavirus, thereby spurring the immune system to prepare an arsenal against the COVID-19-causing virus.

Among leading global COVID-19 vaccine developers, China’s CanSino Biological and Russia’s Gamaleya Institute with its Sputnik V vaccine are also relying on this approach. The Pfizer/BioNtech and Moderna vaccines use mRNA technology.

The rollout of J&J’s vaccine has been slowed by issues at production plants.

The company has supplied the United States with at least 20 million doses but is behind schedule on its deliveries. Problems at a Baltimore, Maryland plant run by outside contractor Emergent BioSolutions forced the companies to trash a batch of vaccine substance.

The plant – meant to be one of J&J’s main U.S. manufacturing facilities – has yet to be approved by U.S. regulators to supply vaccine doses, and J&J shipments to the states were expected to fall sharply next week.

J&J only began delivering its COVID-19 vaccine to European Union countries this week. It has committed to delivering 55 million doses to the bloc by the end of June and another 120 million in the third quarter.

J&J has been doing vaccinations in South Africa to study the effects on health workers, and had vaccinated just under 300,000 people there as of Monday, according to data from the country’s health department. J&J recently struck a deal with the African Union for up to 400 million doses.

Europe’s drugs regulator continues to recommend the use of AstraZeneca’s COVID-19 vaccine, saying the benefits outweigh the risks. Several EU countries, however, have limited its use to certain age groups.

Australia has no current plans to add J&J’s coronavirus vaccine to its immunization drive, authorities said on Tuesday, as it moves away from procuring vaccines under review for potential links to blood clots.

(Reporting by Manas Mishra in Bengaluru and Michael Erman in Maplewood, N.J., additional reporting by Julie Steenhuysen in Chicago and Ludwig Burger in Frankfurt; Editing by Sriraj Kalluvila and Mark Potter)

U.S. administers 168.6 million doses of COVID-19 vaccines: CDC

(Reuters) – The United States has administered 168,592,075 doses of COVID-19 vaccines in the country as of Tuesday morning and distributed 219,194,215 doses, the U.S. Centers for Disease Control and Prevention said.

The tally is for Moderna, Pfizer/BioNTech, and Johnson & Johnson’s vaccines as of 6:00 a.m. ET on Tuesday, the agency said.

According to the tally posted on April 5, the agency had administered 167,187,795 doses of the vaccines, and distributed 207,891,395 doses.

The agency said 108,301,234 people had received at least one dose while 63,016,976 people are fully vaccinated as of Tuesday.

A total of 7,748,620 vaccine doses have been administered in long-term care facilities, the agency said.

(Reporting by Manojna Maddipatla in Bengaluru)

World Bank threatens to cut Lebanon’s vaccine aid over line-jumping

By Ellen Francis and Laila Bassam

BEIRUT (Reuters) – The World Bank threatened on Tuesday to suspend its multi-million dollar financing for Lebanon’s COVID-19 vaccination drive over politicians jumping the line.

The controversy, which echoed favoritism by elites in other countries as the world rushes to inoculate against the coronavirus, added to frustration among Lebanese over delays and violations in the vaccination campaign.

Local media and politicians said that some lawmakers got shots in parliament on Tuesday – despite not necessarily being in priority groups.

“Upon confirmation of violation, World Bank may suspend financing for vaccines and support for COVID19 response across Lebanon!!” the World Bank’s regional director Saroj Kumar Jha tweeted, saying it would be a breach of the national plan.

“I appeal to all, I mean all, regardless of your position, to please register and wait for your turn.”

The World Bank’s reallocation of $34 million has enabled Lebanon to receive its first two batches of about 60,000 Pfizer-BioNTech doses this month. The bank had said it would monitor the vaccine rollout and warned against favoritism in Lebanon, where decades of waste and corruption brought a financial meltdown and protests.

‘SELFISH’

One lawmaker, who asked not to be named, told Reuters that some older current and former lawmakers, as well as administrative staff, were vaccinated in the parliament hall.

“What’s the big deal? … They’re registered,” he said, referring to an online platform for vaccines. He added that doses were also sent last week to the Baabda palace for President Michel Aoun and about 16 others.

Aoun’s office said it would issue a statement.

Deputy parliament speaker Elie Ferzli, who at 71 is not in the first phase priority group, tweeted that he got a shot.

The doctor who heads Lebanon’s COVID-19 vaccination committee, Abdul Rahman Bizri, said it was unaware vaccines would be sent to parliament. “What happened today is unacceptable,” he told reporters.

Around the nation, outrage spread.

“My grandfather is an 85-year-old decent man suffering from heart and cardiovascular problems. My grandfather is a priority and he still did not get the vaccine,” tweeted Jad al-Hamawi.

“What are you? Bunch of hypocrites. Selfish. Criminals.”

Jonathan Dagher added on Facebook: “As our loved ones gasp for oxygen in COVID-19 wards, MPs cut the line today to take the vaccine.”

The health ministry did not immediately comment.

A surge in infections since January has brought Lebanon’s death toll over 4,300.

(Reporting by Ellen Francis and Laila Bassam; Additional reporting by Maha El Dahan; Editing by Andrew Cawthorne)

South African virus variant may resist antibody drugs; Pfizer/BioNTech vaccine seems to work vs UK variant

By Nancy Lapid

(Reuters) – The following is a roundup of some of the latest scientific studies on the novel coronavirus and efforts to find treatments and vaccines for COVID-19, the illness caused by the virus.

South African variant may resist current antibody treatments

The variant of the new coronavirus identified in South Africa can resist, or “escape,” antibodies that neutralize earlier versions of the virus, scientists have found. It “exhibits complete escape” from three classes of monoclonal antibodies manufactured for treating COVID-19 patients, and it shows “substantial or complete” resistance to neutralizing antibodies in blood donated by COVID-19 survivors, the scientists reported on Tuesday on bioRxiv ahead of peer review. Similarities between the South Africa variant and another variant identified in Brazil suggest the Brazilian variant will show similar resistance, they added. Liam Smeeth of the London School of Hygiene and Tropical Medicine, who was not involved in the study, noted that these were laboratory tests, and it would be unwise to extrapolate the findings to humans at this point. “The data do raise the possibility that the protection gained from past infection with COVID-19 may be lower for re-infection with the South African variant,” he said. “The data also suggest that the existing vaccines could be less effective against the South African variant.” He called for large studies among populations where the variant is common.

Pfizer/BioNTech shot likely protects against UK variant

The COVID-19 vaccine from Pfizer Inc and BioNTech SE is likely to protect against the more infectious variant of the virus discovered in Britain and now spreading around the world, according to laboratory tests. Researchers took blood samples from 16 people who had received the vaccine and exposed the blood to a synthetic virus, or pseudovirus, that was engineered to have 10 mutations found in the UK variant. The antibodies that had developed in response to the vaccine effectively neutralized the pseudovirus, according to a report posted on Tuesday on bioRxiv ahead of peer review. “This makes it very unlikely that the UK variant will escape from the protection provided by the vaccine,” said Jonathan Stoye, a virus scientist at Britain’s Francis Crick Institute who was not involved in the research. Similar experiments are needed with the more concerning variant first found in South Africa, he suggested. AstraZeneca Plc, Moderna Inc and CureVac NV are also testing whether their respective vaccines will protect against the fast-spreading variants.

Immune system will remember how to make COVID-19 antibodies

People who have recovered from COVID-19 can likely mount a fast and effective response to the virus if they encounter it again because their immune system’s “B cells” will remember how to make the antibodies needed to fight it, a new study shows. Researchers tracked 87 COVID-19 survivors for six months and found that while levels of antibodies to the virus may decline over time, the number of memory B cells remains unchanged. The antibodies produced by these cells are more potent than the patients’ original antibodies and may be more resistant to mutations in the spike protein the virus uses to break into cells, they said. For example, they found, the antibodies could recognize and neutralize at least one of the mutations in the South African variant of the virus that has caused concern among health experts. Even if antibody levels fall, B cells will remember how to make them when necessary, according to study leader Michel Nussenzweig of Rockefeller University, whose findings were reported on Monday in Nature. If this is true at six months, as in this study, it is safe to assume it is probably still true for longer periods, he added. People who have recovered from COVID-19 “may become infected but the immune system will be prepped to fight off the infection,” Nussenzweig said.

Mortality higher when ICUs are packed with COVID-19 patients

The more full an intensive care unit (ICU) is with COVID-19 patients, the higher the mortality rate among those patients, new data suggest. When researchers tracked outcomes of 8,515 COVID-19 patients admitted to 88 U.S. Veterans Affairs hospitals in 2020, they found that survival rates improved between March and August. Throughout the study period, however, the risk of death was nearly double when at least 75% of ICU beds were filled with COVID-19 patients, compared to when they accounted for no more than 25% of ICU beds. COVID-19 mortality “increases during periods of peak demand,” said Dr. Dawn Bravata of the Richard L Roudebush VA Medical Center in Indianapolis who co-led the study published on Tuesday in JAMA Network Open. “The more the public can do to avoid infections, the better,” she added. In addition, Bravata said, “facilities within a healthcare system or within a geographic region should collaborate to triage critically ill patients with COVID-19 to sites with greater ICU capacity to reduce strain on any one facility.”

(Reporting by Nancy Lapid, Linda Carroll, Kate Kelland and Ludwig Burger; Editing by Bill Berkrot)

New York nurse given COVID-19 vaccine as U.S. rollout begins

By Jonathan Allen and Gabriella Borter

NEW YORK (Reuters) -An intensive care unit nurse became the first person in New York state to receive the Pfizer/BioNTech COVID-19 vaccine on Monday, marking a pivotal turn in the U.S. effort to control the deadly virus.

Sandra Lindsay, who has treated some of the sickest COVID-19 patients for months, was given the vaccine at Long Island Jewish Medical Center in the New York City borough of Queens, an early epicenter of the country’s COVID-19 outbreak, receiving applause on a livestream with New York Governor Andrew Cuomo.

“It didn’t feel any different from taking any other vaccine,” Lindsay said. “I feel hopeful today, relieved. I feel like healing is coming. I hope this marks the beginning of the end of a very painful time in our history. I want to instill public confidence that the vaccine is safe.”

Minutes after Lindsay received the injection, President Donald Trump sent a tweet: “First Vaccine Administered. Congratulations USA! Congratulations WORLD!”

Northwell Health, the largest health system in New York state, operates some of the select hospitals in the United States that were administering the country’s first inoculations of the Pfizer/BioNTech COVID-19 vaccine outside trials on Monday.

The vaccine, developed by Pfizer and its German partner BioNTech, won emergency-use approval from federal regulators on Friday after it was found to be 95% effective in preventing illness in a large clinical trial.

The first 2.9 million doses began to be shipped to distribution centers around the country on Sunday, just 11 months after the United States documented its first COVID-19 infections.

As of Monday, the United States had registered more than 16 million cases and nearly 300,000 deaths from the virus.

Health officials in Texas, Utah, South Dakota, Ohio and Minnesota said they also anticipated the first doses of the vaccine would be received at select hospitals on Monday and be administered right away.

LOGISTICAL CHALLENGE

The first U.S. shipments of coronavirus vaccine departed from Pfizer’s facility in Kalamazoo, Michigan, on Sunday, packed into trucks with dry-ice to maintain the necessary sub-Arctic temperatures, and then were transported to UPS and FedEx planes waiting at air fields in Lansing and Grand Rapids, kicking off a national immunization endeavor of unprecedented complexity.

The jets delivered the shipments to UPS and FedEx cargo hubs in Louisville and Memphis, from where they were loaded onto planes and trucks to be distributed to the first 145 of 636 vaccine-staging areas across the country. Second and third waves of vaccine shipments were due to go out to the remaining sites on Tuesday and Wednesday.

“This is the most difficult vaccine rollout in history. There will be hiccups undoubtedly but we’ve done everything from a federal level and working with partners to make it go as smoothly as possible. Please be patient with us,” U.S. Surgeon General Jerome Adams told Fox News on Monday, adding that he would get the shot as soon as he could.

The logistical effort is further complicated by the need to transport and store the Pfizer/BioNTech vaccine at minus 70 Celsius (minus 94 Fahrenheit), requiring enormous quantities of dry ice or specialized ultra-cold freezers.

Workers clapped and whistled as the first boxes were loaded onto trucks at the Pfizer factory on Sunday.

“We know how much people are hurting,” UPS Healthcare President Wes Wheeler said on Sunday from the company’s command center in Louisville, Kentucky. “It’s not lost on us at all how important this is.”

MORE DOSES ON THE WAY

More than 100 million people, or about 30% of the U.S. population, could be immunized by the end of March, Moncef Slaoui, the chief advisor to the U.S. government’s Operation Warp Speed coronavirus vaccine initiative, said in an interview on Sunday.

Healthcare workers and elderly residents of long-term care homes will be first in line to get the inoculations of a two-dose regimen given about three weeks apart. That would still leave the country far short of the herd immunity that would halt virus transmission, so health officials have warned that masks and social distancing will be needed for months to control the currently rampaging outbreak. Pfizer Chief Executive Officer Albert Bourla told CNN in an interview on Monday that most of the 50 million vaccine doses the company will provide this year have been manufactured, adding that it plans on producing 1.3 billion doses next year. Approximately half will be allocated to the United States, he said. But Bourla said Pfizer is “working very diligently” to increase the amount of doses available because demand is very high. At the same time, he said, the company has not reached an agreement with the U.S. government on when to provide an additional 100 million doses next year. “We can provide them the additional 100 million doses, but right now most of that we can provide in the third quarter,” Bourla said. “The U.S. government wants them in the second quarter so are working very collaboratively with them to make sure that we can find ways to produce more or allocate the doses in the second quarter.” Slaoui said the United States hopes to have about 40 million vaccine doses – enough for 20 million people – distributed by the end of this month. That would include vaccines from both Pfizer and Moderna Inc. An outside U.S. Food and Drug Administration advisory panel is scheduled to consider the Moderna vaccine on Thursday, with emergency use expected to be granted shortly after. On Friday, Moderna announced it had struck a deal with the U.S. government to deliver 100 million additional doses in the second quarter.

(Reporting by Jonathan Allen, Gabriella Borter, Lisa Lambert, Lisa Baertlein and Brendan O’Brien; Editing by Angus MacSwan and Paul Simao)