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)

Pfizer, Moderna COVID-19 vaccines highly effective after first shot in real-world use, -U.S. study

By Ankur Banerjee and Vishwadha Chander

(Reuters) – COVID-19 vaccines developed by Pfizer Inc with BioNTech SE and Moderna Inc reduced the risk of infection by 80% two weeks or more after the first of two shots, according to data from a real-world U.S. study released on Monday.

The risk of infection fell 90% by two weeks after the second shot, the study of just under 4,000 vaccinated U.S. healthcare personnel and first responders found.

The study by the U.S. Centers for Disease Control and Prevention (CDC) evaluated the vaccines’ ability to protect against infection, including infections that did not cause symptoms. Previous clinical trials by the companies evaluated their vaccine’s efficacy in preventing illness from COVID-19.

The findings from of the real-world use of these messenger RNA (mRNA) vaccines confirm the efficacy demonstrated in the large controlled clinical trials conducted before they received emergency use authorizations from the U.S. Food and Drug Administration.

The study looked at the effectiveness of the mRNA vaccines among 3,950 participants in six states over a 13-week period from Dec. 14, 2020 to March 13, 2021.

“The authorized mRNA COVID-19 vaccines provided early, substantial real-world protection against infection for our nation’s healthcare personnel, first responders, and other frontline essential workers,” CDC Director Rochelle Walensky said in a statement.

The new mRNA technology is a synthetic form of a natural chemical messenger being used to instruct cells to make proteins that mirror part of the novel coronavirus. That teaches the immune system to recognize and attack the actual virus.

The CDC study comes weeks after real-world data from Israel suggested that the Pfizer/BioNTech vaccine was 94% effective in preventing asymptomatic infections.

Some countries, including Britain and Canada, are allowing extended gaps between doses that differ from how the vaccines were tested in clinical trials in order to alleviate supply constraints. In the trials, there was a three-week gap between Pfizer shots and four weeks for the Moderna vaccine.

In Britain, authorities said in January that data supported its decision to move to 12 weeks between the first and second Pfizer/BioNtech shots. Pfizer and its German partner have warned that they had no evidence to prove that.

(Reporting by Ankur Banerjee and Vishwadha Chander in Bengaluru; Editing by Peter Henderson and Bill Berkrot)

Moderna plans trial of altered COVID-19 vaccine booster to address South Africa variant

(Reuters) – Moderna said on Monday it plans to start clinical trials of an altered booster version of its COVID-19 vaccine aimed at the South African variant after tests showed its authorized vaccine may produce a diminished antibody response.

It will also test an additional booster shot of its authorized vaccine in trials to see if it boosts antibody reaction against the South Africa variant. The current regimen is for two shots four weeks apart.

The company said in a press release that it was being cautious and that the two-dose regimen of the vaccine was still expected to be protective against the South African and other variants detected to date.

The company said the vaccine did not see any impact from the U.K. variant – which has been shown to be more transmissible – in the tests.

The company said it plans to publish data from its tests against the South African and U.K. variants on the website bioRxiv.

(Reporting by Manas Mishra in Bengaluru and Caroline Humer in New York; Editing by Maju Samuel and Saumyadeb Chakrabarty)

Moderna says possible allergic reactions to COVID-19 vaccine under investigation

(Reuters) – Moderna Inc said on Tuesday it had received a report from California’s health department that several people at a center in San Diego were treated for possible allergic reactions to its COVID-19 vaccine from a particular batch.

The company’s comments come after California’s top epidemiologist on Sunday issued a statement recommending providers pause vaccination from lot no. 41L20A due to possible allergic reactions that are under investigation.

“A higher-than-usual number of possible allergic reactions were reported with a specific lot of Moderna vaccine administered at one community vaccination clinic. Fewer than 10 individuals required medical attention over the span of 24 hours,” the epidemiologist said in a statement.

The vaccine maker said it was unaware of comparable cases of adverse events from other vaccination centers which may have administered vaccines from the same lot or from other lots of its vaccine.

A total of 307,300 doses from the lot remain in storage, Moderna said, of the total 1,272,200 doses that were produced in the batch.

Moderna said it was working closely with U.S. health regulators to understand the cases and whether pausing the use of the lot was warranted.

Nearly a million doses from the lot have already been distributed to about 1,700 vaccination sites in 37 states, Moderna said.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Vinay Dwivedi and Shinjini Ganguli)

Moderna raises 2021 vaccine output forecast to at least 600 million doses

(Reuters) – Moderna Inc said on Monday it would produce at least 600 million doses of its COVID-19 vaccine in 2021, up by 100 million doses from its previous forecast, as the United States continues to roll-out the vaccine.

The company was working to invest and hire in order to deliver up to 1 billion doses this, the higher end of its production forecast, it said.

Moderna said it has so far supplied about 18 million doses to the U.S. government as part of a deal for 200 million doses. It has also signed a deal with the Canadian government for 40 million doses.

(Reporting by Manas Mishra in Bengaluru; Editing by Arun Koyyur)

Drugmakers rush to test whether vaccines stop coronavirus variant

By John Miller and Patricia Weiss

ZURICH/FRANKFURT (Reuters) – Drug makers including BioNTech and Moderna are scrambling to test their COVID-19 vaccines against the new fast-spreading variant of the virus that is raging in Britain, the latest challenge in the breakneck race to curb the pandemic.

Ugur Sahin, chief executive of Germany’s BioNTech which with partner Pfizer took less than a year to get a vaccine approved, said on Tuesday he needs another two weeks to know if his shot can stop the mutant variant of the virus.

Moderna expects immunity from its vaccine to protect against the variant and is performing more tests in coming weeks to confirm, the company said in a statement to CNN. Moderna did not immediately respond to Reuters’ requests for comment.

The mutation known as the B.1.1.7 lineage may be up to 70% more infectious and more of a concern for children. It has sown chaos in Britain, prompting a wave of travel bans that are disrupting trade with Europe and threatening to further isolate the island country.

Sahin said there are nine mutations on the virus.

While he does not believe any are significant enough to skirt the protection afforded by BioNTech’s mRNA vaccine, which was approved by the European Union on Monday, he said another 14 days or so of study and data collection are needed before offering a definitive answer.

“Scientifically it is highly likely that the immune response by this vaccine can also deal with this virus variant,” he said on a call with reporters.

“The vaccine contains more than 1,270 amino acids, and only 9 of them are changed (in the mutant virus). That means that 99% of the protein is still the same.”

Germany’s CureVac said it does not expect the variant to affect the efficacy of its experimental shot, which is based on the same messenger RNA (mRNA) technology used by Pfizer-BioNTech.

It started late stage clinical trials on its vaccine candidate last week and is constantly reviewing variants, which the company said are common as viruses spread.

Even though there are multiple mutations, BioNTech’s Sahin said, most of the sites on the virus that are recognized by the body’s T-cell response are unchanged, and multiple antibody binding sites are also conserved.

MRNA ADVANTAGE

In the event that the variant presents vaccine developers with an unexpected challenge, an advantage of mRNA is that scientists can quickly re-engineer genetic material in the shot to match that of the mutated protein, whereas modifying traditional vaccines would require extra steps.

“In principle, the beauty of the mRNA technology is we can directly start to engineer a vaccine which completely mimics this new mutation,” Sahin said.

“We could be able to provide a new vaccine technically within six weeks. Of course, this is not only a technical question. We have to deal with how regulators… would see that.”

Britain’s chief scientific adviser Patrick Vallance said on Saturday vaccines appeared to be adequate in generating an immune response to the variant of the coronavirus.

The World Health Organization (WHO) said on Tuesday it will convene a meeting of members to discuss strategies to counter the mutation.

Moderna’s coronavirus vaccine faces U.S. FDA expert panel review

(Reuters) – A panel of outside advisers to the U.S. Food and Drug Administration is expected to endorse emergency use of Moderna Inc’s coronavirus vaccine during a meeting on Thursday, as the nation prepares to roll out a second vaccine.

The panel vote on whether the vaccine’s benefits outweigh its risks is likely to come some time after 3 pm ET (2000 GMT), with an FDA authorization expected as soon as Friday.

This is the same committee of expert advisers that last week backed the COVID-19 vaccine from Pfizer Inc and German partner BioNTech SE, clearing the way for the FDA emergency use authorization (EUA) a day later.

That vaccine is being distributed throughout the country. A massive inoculation program began at U.S. hospitals on Monday.

The Moderna vaccine uses similar messenger RNA technology but with less onerous cold storage requirements than the Pfizer/BioNTech shot, making it a better option for remote and rural areas. Both vaccines were about 95% effective in preventing illness in pivotal clinical trials.

The FDA advisory committee is likely to discuss Moderna’s reports of side effects from its 30,000-person trial, which were more frequent than those reported by Pfizer. These were primarily relatively short-lived reactions to the vaccination rather than serious adverse events.

SVB Leerink analysts said the Moderna vaccine appears less tolerable than the Pfizer/BioNTech shot, but noted that is not a proper comparison across trials and unlikely to stand in the way of an EUA.

The FDA staff did not raise any serious concerns about safety in documents published on Tuesday in preparation for the meeting. It said a link between Bell’s palsy, which causes temporary paralysis of facial muscles, and the vaccine could not be ruled out after some cases were reported in trials of both vaccines.

Pfizer and BioNTech said those cases occurred at the same rate as in the general population.

Moderna is seeking authorization for people aged 18 and older. That could sidestep the lively discussion last week among panel members about whether there was enough data to authorize use of the Pfizer/BioNTech vaccine in adolescents aged 16 and 17. They ultimately voted to back that vaccine for those 16 and older.

Initial Moderna vaccine supply would likely go to the United States, which has signed deals to secure as many as 200 million doses and is expecting the first 20 million this month. The vaccine is administered in two doses about four weeks apart.

The company has also signed supply deals with Canada, the European Union and the UK. The vaccine is undergoing a “rolling review” by regulators for all three.

(Reporting by Manas Mishra in Bengaluru; Editing by Caroline Humer and Bill Berkrot)

Moderna to supply four million more doses of COVID-19 vaccine to Israel

(Reuters) – Moderna Inc said on Friday it has extended its contract with the Israeli health ministry to supply an additional 4 million doses of its COVID-19 vaccine candidate.

Israel has now secured access to 6 million doses of Moderna’s mRNA-1273, currently under review in the country.

Financial terms and delivery timelines related to the deal were not disclosed.

In June, Israel signed an agreement with Moderna for its vaccine to protect its people from the new coronavirus. The country, with a population of 9 million, has reported 339,942 cases and 2,890 deaths, according to a Reuters tally.

It has also reached an understanding with AstraZeneca Plc to receive about 10 million doses of its experimental COVID-19 vaccine.

Moderna said it continues to scale up its global manufacturing to boost delivery by about 500 million doses per year, and possibly up to 1 billion doses a year, beginning 2021.

The company has submitted applications seeking emergency use authorization in the United States and EU after full results from a late-stage study showed the vaccine was 94.1% effective with no serious safety concerns.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Shinjini Ganguli)

AstraZeneca vaccine can be up to 90% effective; COVID-19 reinfection unlikely for at least six months

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.

AstraZeneca COVID-19 vaccine shows up to 90% efficacy

An interim analysis of late-stage trials of AstraZeneca’s COVID-19 vaccine finds it prevented 70% of COVID-19 cases with no confirmed serious adverse effects, the company announced on Monday. In 8,895 participants who got two full doses, the efficacy was 62%. But due to a dosing error that proved to be a happy accident, among 2,741 volunteers who got a half dose followed by a full dose, efficacy rose to 90%. Pfizer and Moderna reported that their vaccines were about 95% effective at preventing illness. But AstraZeneca’s vaccine is cheaper, easier to make, and can be stored at normal refrigerator temperatures. Investment analysts at SVB Leerink said Astra’s vaccine was unlikely to gain U.S. approval because safety data so far are inadequate and the trial design did not meet U.S. requirements for representation of high-risk groups such as the elderly and minorities. AstraZeneca said it plans to seek approval to modify its U.S. study to get more data on the smaller initial dose. Eventually, all three vaccines could prove comparable. “My suspicion is that by the time we are a year down the line, we’ll be using all three vaccines with about 90% protection,” said immunologist Danny Altmann of Imperial College London.

COVID-19 reinfection appears unlikely for at least 6 months

People who have had COVID-19 are unlikely to contract it again for at least six months, British researchers said on Thursday in a report posted on medRxiv ahead of peer review. Between April and November, they tracked more than 12,000 frontline healthcare workers at high risk for infection with the new coronavirus. COVID-19 with symptoms occurred in 89 of 11,052 workers who did not already have antibodies showing exposure to the virus, whereas none of the 1,246 staff with antibodies developed a recurrent infection. Staff with antibodies were also less likely to test positive for COVID-19 without symptoms, the researchers said. “This is really good news because we can be confident that, at least in the short term, most people who get COVID-19 won’t get it again,” said coauthor David Eyre of Oxford’s Nuffield Department of Population Health. Maria van Kerkhove of the World Health Organization added, “We still need to follow these individuals for a longer period of time to see how long immunity lasts.”

Delirium may signal COVID-19 in elderly

Delirium is common among older patients with COVID-19 and may be their only symptom, U.S. researchers warned on Thursday in JAMA Network Open. Among more than 800 COVID-19 patients over age 65 who showed up at emergency departments around the country, nearly 30% had delirium, they found. Overall, delirium was the sixth most common of all the symptoms and signs in these older patients. Those most at risk for delirium included elders with vision or hearing impairment, stroke, Parkinson’s disease and residents of assisted living or skilled nursing facilities. Delirium is not on any official list of COVID-19 signs and symptoms, but the U.S. Centers for Disease Control and Prevention (CDC) should add it, said coauthor Dr. Maura Kennedy of Massachusetts General Hospital in Boston. “Sometimes delirium is the chief complaint when these patients arrive at the emergency department,” Kennedy said. “But there can be a number of reasons they come, including falls that occurred because of the delirium. They may present without what we consider typical COVID-19 symptoms, such as fever, shortness of breath and cough.”

New data help distinguish COVID-19 from flu

Certain findings can help distinguish COVID-19 from influenza or other respiratory illnesses, a new study suggests. Israeli doctors studied 693 hospitalized patients with COVID-19, plus more than 8,000 adults who had been hospitalized in previous years for the flu or severe respiratory infections. Compared to the other patients, those with COVID-19 were on average younger, more overweight, and had fewer preexisting conditions other than dementia, which was more prevalent in COVID-19 patients. Upon hospital admission, COVID-19 patients had overall lower levels of infection-fighting white blood cells and neutrophils, but their hearts were beating faster, they had less oxygen in their blood, and they had higher percentages of immune-system B cells, which produce antibodies to attack invading germs, and T cells, which destroy cells that have become infected. During the first two days of hospitalization, white blood cell and neutrophil levels rose in COVID-19 patients but fell in the other groups, the researchers said in a paper posted on Sunday on medRxiv ahead of peer review. “At the dawn of winter, recognizing the characteristics discriminating COVID-19 from influenza, will be critical to support the management of the current pandemic,” they conclude.

(Reporting by Nancy Lapid, Linda Carroll, Kate Holton, Josephine Mason and Kate Kelland; Editing by Bill Berkrot)

AstraZeneca COVID-19 vaccine shows promise in elderly, trial results by Christmas

By Kate Kelland and Alistair Smout

LONDON (Reuters) – AstraZeneca and Oxford University’s potential COVID-19 vaccine produced a strong immune response in older adults, data published on Thursday showed, with researchers expecting to release late-stage trial results by Christmas.

The data, reported in part last month but published in full in The Lancet medical journal on Thursday, suggest that those aged over 70, who are at higher risk of serious illness and death from COVID-19, could build robust immunity.

“The robust antibody and T-cell responses seen in older people in our study are encouraging,” said Maheshi Ramasamy, a consultant and co-lead investigator at the Oxford Vaccine Group.

“We hope that this means our vaccine will help to protect some of the most vulnerable people in society, but further research will be needed before we can be sure.”

Late-stage, or Phase III, trials are ongoing to confirm the findings, researchers said, and to test whether the vaccine protects against infection with SARS-CoV-2 in a broad range of people, including people with underlying health conditions.

Results of those trials should definitely be known by Christmas, the Oxford Vaccine Group’s director, Andrew Pollard, said, adding it was too early to know whether and how well the vaccine works in preventing COVID-19 disease.

“We’re still waiting to get to the point where we can do the analysis to just work out how well the vaccine can protect people, and we’re getting ever closer to that,” he told journalists.

“We are optimistic that we’ll be able to do that before Christmas, and obviously we’ll share that with you as soon as we can at that point.”

The Oxford-AstraZeneca COVID-19 vaccine candidate, called AZD1222 or ChAdOx1 nCoV-19, had been among the front-runners in global efforts to develop shots to protect against infection with the novel coronavirus, or SARS-CoV-2.

But rival drugmakers Pfizer Inc, BioNTech and Moderna Inc have in the past 10 days edged ahead, releasing data from late-stage COVID-19 vaccine trials that shows more than 90% efficacy.

“We’re not in a rush. We and it’s not a competition with the other developers,” Oxford’s Pollard said, adding that AstraZeneca would release headline efficacy data before it was published in an academic journal.

Oxford University has set a target of 53 infections to start the interim analysis of its late-stage trial results, though “lots of cases” in its trial arms in Britain, South Africa and Brazil mean the exact number of infections reported could differ.

Unlike the Pfizer-BioNTech and Moderna shots, both of which use new technology known as messenger RNA (mRNA), AstraZeneca’s is a viral vector vaccine made from a weakened version of a common cold virus found in chimpanzees.

The Phase II trial reported in The Lancet involved a total of 560 healthy volunteers, with 160 aged 18-55, 160 aged 56-69, and 240 aged 70 or over.

Volunteers got two doses of the vaccine or a placebo, and no serious side effects related to the AZD1222 vaccine were reported, the researchers said.

AstraZeneca has signed several supply and manufacturing deals with companies and governments around the world.

(Reporting by Kate Kelland; Additional reporting by Alistair Smout; Editing by Matthew Lewis, Alexander Smith and Nick Macfie)