New York governor asks Pfizer to directly sell COVID-19 vaccine doses

By Kanishka Singh

(Reuters) – New York Governor Andrew Cuomo asked Pfizer Inc Chief Executive Albert Bourla on Monday if the state could buy COVID-19 vaccine doses directly from the U.S. drugmaker.

Pfizer, however, told Reuters that such a proposal would first require approval by the U.S. Department of Health and Human Services.

“With hospitalizations and deaths increasing across the country this winter, we are in a footrace with the virus, and we will lose unless we dramatically increase the number of doses getting to New Yorkers,” Cuomo said in a letter to Pfizer’s CEO.

Cuomo said he was appealing to Pfizer directly as the company was “not bound by commitments” that Moderna Inc made as part of Operation Warp Speed, the U.S. government’s program to distribute COVID-19 vaccines.

No state has purchased vaccines directly from the producer. Cuomo’s letter did not state how many doses he was seeking or how he would pay for it.

Pfizer said it was open to collaborating with the U.S. Department of Health and Human Services in a way that would ensure quick vaccine distribution to as many Americans as possible.

(Reporting by Kanishka Singh in Bengaluru; Editing by Howard Goller)

Mexico aims to make up for Pfizer vaccine shortfall with others

MEXICO CITY (Reuters) – Mexican President Andres Manuel Lopez Obrador said on Monday the government aimed to compensate for a reduction in deliveries of COVID-19 vaccine doses from Pfizer Inc with those from other providers.

The World Health Organization (WHO) said on Monday it was in advanced talks with Pfizer about including its vaccine in the agency’s portfolio of shots to be shared with poorer countries.

Mexico had been expecting weekly deliveries of some 400,000 doses of the Pfizer vaccine developed with Germany’s BioNTech SE. As a result of the U.S. drugmaker’s WHO agreements, Mexico would for now only be receiving half that total, Lopez Obrador told a regular news conference.

It was not clear how long the reduction would last. Pfizer did not immediately reply to a request for comment.

The Pfizer/BioNTech vaccine is currently the only one being administered in Mexico, which has reported the fourth-highest death toll from the pandemic worldwide.

Mexico has also signed deals to acquire vaccines from Britain’s AstraZeneca Plc and China’s CanSino Biologics. Mexico has approved the AstraZeneca shot and expects to have it by March. It is still reviewing the CanSino vaccine.

Lopez Obrador also noted Mexico was about to complete its review of a Russian vaccine, and would soon have it available, an apparent reference to the Sputnik V product.

Mexico suffered a setback to its drive to inoculate the public with the news over the weekend that the official in charge of the program, Miriam Veras Godoy, had stepped down for personal reasons, according to the health ministry.

(Reporting by Raul Cortes; Editing by Bill Berkrot)

Israel sharing COVID-19 data with Pfizer to help fine-tune vaccine rollout

JERUSALEM (Reuters) – Israel is giving weekly data updates on its COVID-19 outbreak to vaccine maker Pfizer under a collaboration agreement that may help other countries fine-tune their inoculation campaigns and achieve “herd immunity,” officials said.

Israelis began receiving first shots of the vaccine developed by Pfizer and its German partner BioNTech on Dec. 19 in one of the world’s fastest vaccination rollouts.

Israel’s Health Ministry made public most of a 20-page collaboration agreement it signed with Pfizer, which said the aim was “to determine whether herd immunity is achieved after reaching a certain percentage of vaccination coverage in Israel”.

Commercial details such as price and quantity of vaccine shots supplied were not made public, but the agreement said that Israel was relying on Pfizer to deliver enough doses at a fast enough rate to allow it to achieve “herd immunity,” meaning a sufficient portion of the population is immune to the virus.

“While this project is conducted in Israel, the insights gained will be applicable around the world and we anticipate will allow governments to maximize the public health impact of their vaccination campaigns,” BioNTech said on Monday in a statement.

This includes determining potential immunization rates needed to stop the virus from spreading, it said.

The goal, BioNTech said, was “to monitor the evolution of the epidemic over time and at different vaccination rates.”

“This will help us understand whether a potential decrease in cases and deaths can be attributed solely to direct vaccine protection or to both direct and indirect (or ‘herd’) protection,” it said.

During weekly status reports, Israel will provide Pfizer with epidemiological data such as: the number of confirmed COVID-19 cases, hospitalizations, how many patients were on ventilators, how many died, as well as an age and other demographic breakdown.

Such data was available to the public and keeps patients anonymous, Israeli officials said.

About a quarter of Israelis have received their first vaccine shot and 3.5% already got their second dose.

Still, the country is in its third lockdown with infection rates remaining high. More than half a million cases have been reported and 4,005 people have died in Israel since the pandemic began.

(Reporting by Ari Rabinovitch, Ludwig Burger, Nikolaj Skydsgaard and Steven Scheer; Editing by Alex Richardson)

Pfizer, U.S. strike 100 million COVID-19 vaccine deal with 70 million due by June

By Ankur Banerjee and Vishwadha Chander

(Reuters) – The U.S. government will pay Pfizer Inc nearly $2 billion for 100 million additional doses of its COVID-19 vaccine to bolster its supply as the country grapples with a nationwide spike in infections.

Under the new agreement, Pfizer will deliver at least 70 million doses by June 30 and the rest no later than July 31, the company said on Wednesday, bringing the total number of doses to 200 million for a total price of about $4 billion.

The purchase price amounts to $19.50 per shot and is slightly higher than the $18.90 per dose that Reuters has reported the European Union has agreed to pay. The shot has been authorized for use in EU and the United States.

The U.S. deal comes after growing concern that the government had not done enough to secure doses of one of the two authorized vaccines, made more pressing amid a COVID-19 surge that has left hospitals struggling to find beds for the sick.

Pfizer’s two-dose vaccine, developed with German partner BioNTech, is being rolled out across the United States after the shot won emergency use authorization earlier this month. The country has also authorized a vaccine from Moderna Inc.

Pfizer and the government have said that they had been negotiating the terms of the agreement, with the company indicating it was trying to work out how to deliver the doses in the second quarter.

Pfizer and BioNTech have said they expect to produce 1.3 billion doses in 2021, but executives at the German biotech have said they were trying to boost manufacturing. Governments around the world are scrambling to get enough supplies of the vaccine to tame the pandemic that has killed about 1.7 million people globally and crushed economies.

“This new federal purchase can give Americans even more confidence that we will have enough supply to vaccinate every American who wants it by June 2021,” U.S. Department of Health and Human Services Secretary Alex Azar said in a statement.

“Securing more doses from Pfizer and BioNTech for delivery in the second quarter of 2021 further expands our supply of doses across the Operation Warp Speed portfolio.”

Pfizer said last week it may need the U.S. government to help it secure some components needed to make the vaccine. While the company halved its 2020 production target due to manufacturing issues, it said last week its manufacturing is running smoothly now.

The government also has the option to acquire up to an additional 400 million doses of the vaccine.

More than 600,000 Americans have received their first COVID-19 vaccine doses as of Monday, according to the Centers for Disease Control and Prevention (CDC).

The first wave of shots have so far gone to healthcare workers and nursing home residents, as well as some top government officials. Americans in “essential” jobs and those over 75 will likely start to receive vaccines in January while general population vaccinations will start in a few months.

(Reporting by Ankur Banerjee and Vishwadha Chander in Bengaluru; Editing by Caroline Humer and Sriraj Kalluvila)

In COVID-19 milestone for West, Britain starts mass vaccination

By Alistair Smout

LONDON (Reuters) – A 90-year-old grandmother became the world’s first person to receive a fully-tested COVID-19 shot on Tuesday, as Britain began mass-vaccinating its people in a global drive that poses one of the biggest logistical challenges in peacetime history.

Health workers started inoculating the most vulnerable with the vaccine developed by Pfizer and BioNTech, with the country a test case for the world as it contends with distributing a compound that must be stored at -70C (-94F).

Margaret Keenan, who turns 91 in a week, was the first to receive the shot, at a hospital in Coventry, central England.

“It’s the best early birthday present I could wish for because it means I can finally look forward to spending time with my family and friends in the new year after being on my own for most of the year,” she said.

The launch of the vaccine, one of three shots that have reported successful results from large trials, will fuel hope that the world may be turning a corner in the fight against a pandemic that has killed more than 1.5 million people.

Britain, the worst-hit in Europe with over 61,000 deaths, is the first Western nation to begin mass-vaccinations and the first globally to roll out the Pfizer/BioNTech shot.

But despite the relief of people receiving the first dose of the two-dose regimen, they will have to wait three weeks for their second shot, and there is no evidence immunization will reduce transmission of the virus.

“It will gradually make a huge, huge difference. But I stress gradually, because we’re not there yet. We haven’t defeated this virus yet,” Prime Minister Boris Johnson said.

Health Secretary Matt Hancock said he expected millions to be vaccinated by the end of the year, and described the start of the drive as “V-Day.” But he cautioned people should respect social-distancing rules until spring at least, when he hoped the most vulnerable people would be vaccinated.

The country has ordered enough supplies of the Pfizer/BioNTech shot to vaccinate 20 million people. The developers said it was 95% effective in preventing illness in final-stage trials.

Russia and China have both already started giving domestically produced vaccine candidates to their populations, though before final safety and efficacy trials have been completed.

FIVE DAYS IN A FRIDGE

In Britain, about 800,000 doses are expected to be available within the first week, with care-home residents and carers, the over-80s and some health workers prioritized. Hancock said he had a “high degree of confidence” Britain would take delivery of another batch of the vaccine next week.

“I know we’re absolutely bursting at the doors with COVID patients, so I more than anybody wants it to happen quickly,” said Ami Jones, a hospital intensive-care consultant from Wales who received the jab before going to work.

The country is relatively small with good infrastructure. Yet the logistical challenges in distributing the vaccine, which only lasts five days in a regular fridge, mean it will first go to dozens of hospitals and cannot yet be taken into care homes.

Bigger tests could await for the Pfizer/BioNTech shot, as well as a vaccine from Moderna, which was found to have a similar level of success in trials and is based on the same mRNA genetic technology that requires such ultra-cold storage.

Transport and distribution could prove more challenging in hot countries and bigger nations such as the United States and India, which have been worst-hit by COVID-19 and are expected to approve the shot for emergency use in the coming days or weeks.

South Korea, which has coped relatively well with the pandemic, sounded a note of caution, saying it would not hurry vaccine rollouts, partly to give it time to observe potential side-effects in other countries. Vaccinations may start in the first half of 2021, the health ministry added.

The third vaccine to have had trial success, developed by AstraZeneca and Oxford University, is viewed as offering one of the best hopes for many developing countries because it is cheaper and can be transported at normal fridge temperatures. Late-stage trials found it had an average success rate of 70%.

Britain hopes for regulatory approval of the Oxford/AstraZeneca shot in the next couple of weeks.

A SHOT FOR SHAKESPEARE

Britain approved the Pfizer/BioNTech vaccine for emergency use less than a week ago, and is rolling it out ahead of the United States and European Union.

The Pfizer/BioNTech vaccine is being imported from Belgium, while initial supplies of the AstraZeneca/Oxford shot are being shipped from Germany.

“Of course, it adds complexity,” Steve Bates, chief executive of the BioIndustry Association, told reporters of the possible impact of Brexit. “But there is a robust plan for alternative routes and mitigation.”

In total Britain has ordered 40 million doses of the Pfizer/BioNTech shot, enough to vaccinate 20 million people in the country of 67 million. It has ordered 357 million doses of seven different COVID-19 vaccines in all.

Amid the gravity of the pandemic, the vaccination on Tuesday of one William Shakespeare, an 81-year-old of Warwickshire in England, was greeted with humor on social media.

Twitter users joked about “The Taming of the Flu” and “The Two Gentlemen of Corona”. Some asked, if Margaret Keenan was patient 1A, was Shakespeare “Patient 2B or not 2B?”.

(Reporting by Alistair Smout; Additional reporting by Sarah Young, Kate Holton and Natalie Thomas; Editing by Guy Faulconbridge and Pravin Char)

Moderna to seek U.S. and EU authorization for its vaccine on Monday

By Julie Steenhuysen and Michael Erman

(Reuters) – Moderna Inc will apply for U.S. and European emergency authorization for its COVID-19 vaccine on Monday after full results from a late-stage study showed it was 94.1% effective with no serious safety concerns, the company said.

Moderna also reported that its vaccine’s efficacy rate was consistent across age, race, ethnicity and gender demographics as well as having a 100% success rate in preventing severe cases of a disease that has killed nearly 1.5 million people.

The filing sets Moderna’s product up to be the second vaccine likely to receive U.S. emergency use authorization this year following a shot developed by Pfizer and BioNTech which had a 95% efficacy rate.

“We believe that we have a vaccine that is very highly efficacious. We now have the data to prove it,” Moderna Chief Medical Officer Tal Zaks said. “We expect to be playing a major part in turning around this pandemic.”

Of the 196 people who contracted COVID-19 out of over 30,000 volunteers, 185 had received a placebo and 11 got the vaccine. Moderna reported 30 severe cases, all in the placebo group, which means the vaccine was 100% effective against severe cases.

Moderna shares opened 13% higher at a record $144 following the results and then went on to hit a peak of $150.14, or a gain of 668% so far this year.

“As the numbers of cases reported grows, confidence grows that this amazing protection will be maintained in a product that can be rolled out to protect the public,” said Alexander Edwards, associate professor in biomedical technology at Britain’s University of Reading.

In addition to filing its U.S. application, Moderna said it would seek conditional approval from the European Medicines Agency, which is already reviewing its data, and would continue to talk with other regulators doing similar rolling reviews.

“Although we await the full details of these results in published form, we can now assume that this vaccine will be approved for use in December,” said Gillies O’Bryan-Tear, chair of policy and communications at Britain’s Faculty of Pharmaceutical Medicine.

He expected Britain’s Medicines and Healthcare products Regulatory Agency to approve the vaccine within two weeks.

Pfizer has already applied for emergency use authorization in the United States and Europe, putting it about a week ahead of Moderna.

‘JUST OVERWHELMING’

Moderna said it was on track to have about 20 million doses of its vaccine ready to ship in the United States by the end of 2020, enough to inoculate 10 million people.

Switzerland’s Lonza, which has a contract with Moderna to supply ingredients for the vaccine, rose 4.4%.

The vaccines developed by both Moderna and Pfizer/BioNTech use a new technology called synthetic messenger RNA (mRNA) whereas others, such as Britain’s AstraZeneca, are using more traditional methods.

AstraZeneca has announced an average efficacy rate of 70% for its shot and as much as 90% for a subgroup of trial participants who got a half dose, followed by a full dose. But some scientists have expressed doubts about the robustness of the 90% efficacy figure for the smaller group.

Moderna’s latest efficacy result is slightly lower than an interim analysis released on Nov. 16 of 94.5% effectiveness, a difference that Zaks said was not statistically significant.

“At this level of effectiveness, when you just do the math of what it means for the pandemic that’s raging around us, it’s just overwhelming,” said Zaks, who said he cried when he saw the final results over the weekend.

Both the Moderna and Pfizer vaccines proved more effective than anticipated and were far superior to the 50% benchmark set by the U.S. Food and Drug Administration (FDA).

The past few weeks of positive vaccine results have ignited hopes for an end to a pandemic that has battered economies and come as new infections and COVID-19 hospitalizations are at record levels across the United States.

Independent advisers to the FDA are scheduled to meet on Dec. 10 to review Pfizer’s data and make a recommendation to the U.S. regulator. They will review Moderna’s data a week later.

Soon after getting the green light, Moderna expects its vaccine to be shipped to distribution points across the United States by the government’s Operation Warp Speed program and drug distributor McKesson Corp.

The distribution is expected to be easier than Pfizer’s because while it needs to be stored in a freezer, it does not require the ultra-cold temperature needed by Pfizer’s vaccine.

CONSISTENT ACROSS AGE AND ETHNICITY

Moderna said the 196 COVID-19 cases in its trial included 33 adults over 65 years old and 42 volunteers from racially diverse groups, including 29 Latinos, 6 Blacks, 4 Asian Americans and 3 multiracial participants. There was one death related to COVID-19 in the placebo group during the trial.

“This is as black and white as an effect on a population will be. Your chances of actually being sick if you’ve been vaccinated are decreased 20-fold,” said Moderna’s Zaks.

Azra Ghani, chair in infectious disease epidemiology at Imperial College London, said Monday’s details confirmed the vaccine was highly effective, including against severe cases.

“Whilst this does not exclude some risk of severe disease after vaccination given the relatively small number of severe cases, these results suggest very high efficacy,” she said.

Moderna reported no new side effects since its interim analysis, which showed the most common side effects were fatigue, injection site redness and pain, headache and body aches, which rose after the second dose and were short-lived.

Zaks said the vaccine caused significant flu-like symptoms in some participants which, “goes hand-in-hand with having such a potent vaccine.” But it has not caused any significant safety concerns so far, he said.

Moderna plans to start a new trial to test the vaccine in adolescents before the end of the year, followed by another in even younger volunteers early in 2021. It hopes to have the vaccine available for adolescents by September, Zaks said.

Other vaccine makers have said they are studying their vaccines in young people as well.

(Reporting by Julie Steenhuysen and Michael Erman; Additional reporting by Ankur Banerjee and Manas Mishra in Bengaluru and Kate Kelland in London; Editing by Bill Berkrot, Edwina Gibbs and David Clarke)

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)

Pfizer is first to apply for U.S. emergency use for COVID-19 vaccine

By Vishwadha Chander

(Reuters) – Pfizer Inc. said it will apply to U.S. health regulators on Friday for emergency use authorization (EUA) of its COVID-19 vaccine, the first such application in a major step toward providing protection against the new coronavirus.

The application to the U.S. Food and Drug Administration (FDA) comes just days after Pfizer and German partner BioNTech SE reported final trial results that showed the vaccine was 95% effective in preventing COVID-19 with no major safety concerns.

Pfizer’s shares rose 1.6% and BioNTech climbed 6% on the news that a vaccine could soon be available, raising hopes for the end of a pandemic that has claimed more than a quarter of a million lives in the United States and over 1.3 million worldwide.

The application also includes safety data on about 100 children 12-15 years of age. The company said 45% of U.S. trial participants are 56-85 years old.

If the data is solid, “we literally could be weeks away from the authorization of a 95% effective vaccine,” U.S. Health Secretary Alex Azar said on CBS’ “This Morning”.

The companies expect the FDA to grant the EUA by mid-December and said they will begin shipping doses almost immediately. Pfizer has said it expects to have 50 million vaccine doses ready this year, enough to protect 25 million people.

An FDA advisory committee tentatively plans to meet Dec. 8-10 to discuss the vaccine, a source familiar with the situation told Reuters, though the dates could change.

The final trial data showed the vaccine provided a similar level of protection across different ages and ethnicities – an encouraging result as the disease disproportionately hurts the elderly and minorities.

Of the 170 volunteers who contracted COVID-19 in Pfizer’s trial involving over 43,000 people, 162 had received only a placebo, meaning the vaccine was 95% effective, far higher than originally expected. U.S. FDA had set minimum bar for efficacy of 50%.

Pfizer said nearly 42% of global participants and 30% of U.S. participants in the Phase 3 study have racially and ethnically diverse backgrounds.

“Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine,” Pfizer Chief Executive Officer Albert Bourla said in a statement.

Moderna Inc. is expected to be the next company to seek a U.S. emergency use nod for a COVID-19 vaccine. An initial analysis of data from its late-stage trial showed the vaccine was 94.5% effective. Final results and safety data are expected in the coming days or weeks.

Both the Pfizer/BioNTech and Moderna vaccines work using a new technology to trigger an immune response known as synthetic messenger RNA that can be produced at scale much more quickly than traditional vaccines.

Of dozens of drugmakers and research institutions racing to develop COVID-19 vaccines, the next late-stage data is expected to come from AstraZeneca Plc, which is working with the University of Oxford, in November or December.

Johnson & Johnson said it expects to have data needed to seek U.S. authorization for its experimental vaccine by February.

(Reporting by Vishwadha Chander in Bengaluru, additional reporting by Ankur Banerjee in Bengaluru and Doina Chiacu in Washington; Editing by Bill Berkrot, Shinjini Ganguli and Chizu Nomiyama)

COVID-19 survivors may have long lasting immunity; Pfizer vaccine is 95% effective in trial

COVID-19 survivors may have long lasting immunity; Pfizer vaccine is 95% effective in trial
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.

Immune protection against severe reinfection appears lasting

Regardless of their detectable antibody levels, most COVID-19 survivors are likely to have lasting protection against severe COVID-19 if they become re-infected, thanks to other components of the body’s immune response that remember the new coronavirus in different ways, researchers say. In a study of 185 patients, including 41 who had been infected more than six months earlier, scientists at La Jolla Institute for Immunology in California found that multiple branches of the immune system – not just antibodies – recognized the novel coronavirus for at least eight months. For example, so-called memory B cells that could recognize the virus and produce antibodies to fight it were more abundant six months after infection than at one month, they reported in a paper posted on Monday on bioRxiv ahead of peer review. The new findings “suggest that the immune system can remember the virus for years, and most people may be protected from severe COVID-19 for a substantial time,” said study leaders Shane Crotty and Alessandro Sette.

Final data from Pfizer vaccine trial shows 95% efficacy

Final results from Pfizer Inc’s pivotal COVID-19 vaccine trial show it had a 95% success rate – even higher than an earlier analysis – and two months of follow-up data without serious side effects, the company said on Wednesday. In the study involving about 43,000 volunteers, 162 of the 170 who contracted COVID-19 had received a placebo, not the vaccine. Of the 10 participants who had severe COVID-19, only one had received the vaccine. The final analysis of the trial’s data comes a week after interim results showed the vaccine was more than 90% effective. Moderna Inc on Monday released preliminary data for its vaccine, showing 94.5% effectiveness. Pfizer said the efficacy its two-dose vaccine, developed with German partner BioNTech SE, was consistent across different age and ethnic groups. Efficacy in adults over age 65 was over 94%. Pfizer said it expects to make up to 50 million vaccine doses this year – enough to inoculate 25 million people – and up to 1.3 billion doses in 2021.

Respiratory muscle damage linked to severe COVID-19

Critically ill COVID-19 patients develop virus-induced damage of respiratory muscles, scientists at Amsterdam UMC in The Netherlands reported on Monday in JAMA Internal Medicine. They performed autopsy studies of the diaphragm, the main respiratory muscle, in 26 COVID-19 patients who died in the intensive care unit (ICU) and 8 ICU patients who died without COVID-19. In everyone, the diaphragm muscle cell membranes contained a protein called ACE2, which the new coronavirus uses as an entryway into cells. The researchers found genetic evidence of the virus in diaphragm muscle cells in some of those who died from COVID-19, and microscopy analyses showed much more connective tissue scarring (fibrosis) in COVID-19 patients’ diaphragms, indicating damage, study coauthor Coen Ottenheijm told Reuters. He said the diaphragm damage may help explain why it is often difficult for COVID-19 patients to breathe on their own again after they have been on mechanical ventilators in the ICU. It may also explain the persistent shortness of breath in patients recovering from COVID-19.

Cardiac arrest survival is down during the pandemic

U.S. data from early this year suggest the pandemic has led to decreased survival rates after “out-of-hospital” cardiac arrest. Based on nationwide data, the proportion of patients whose hearts could be restarted was 21% lower in March-April 2020 than in the same period in 2019, researchers reported on Saturday at the annual American Heart Association meeting, held virtually this year, and in JAMA Cardiology. The proportion of patients who survived to be discharged from hospitals was also lower in 2020, at 6.6%, versus 9.8% in 2019. Survival rates after out-of-hospital cardiac arrest had nearly doubled in the last 20 years, and “we want to make sure we don’t lose those gains,” said coauthor Dr. Paul Chan of St. Luke’s Mid-America Heart Institute in Missouri. Dr. Clifton Callaway of the University of Pittsburgh, who viewed the presentation but was not involved in the study, said other viewers noted it is more difficult for paramedics to work wearing full personal protective gear as it takes time to put on and can impede emergency care. Furthermore, some patients may have delayed calling for help over concerns of becoming infected with the coronavirus. And some may have also had COVID-19, making their medical condition more severe.

(Reporting by Nancy Lapid, Linda Carroll and Michael Erman; Editing by Bill Berkrot)

Air France-KLM prepares COVID-19 vaccine airlift

PARIS (Reuters) – Air France-KLM is among airlines gearing up for the challenge of transporting millions of doses of temperature-sensitive COVID-19 vaccines in the midst of a travel slump.

Breakthrough vaccines developed by Pfizer and Moderna have yet to win final approval, but the drugmakers, their logistics and cargo providers are not waiting for a green light to activate freight plans.

Air France-KLM, which has decades of experience shipping medicines and vaccines in temperature-controlled conditions, is preparing a test run in coming days to fly out dummy vaccine shipments from KLM’s Amsterdam-Schiphol hub.

The task is complicated by the conditions required by the Pfizer and Moderna shots – with respective storage temperatures of minus 80 Celsius and minus 20C.

“It’s going to be a major logistics challenge,” said Air France cargo chief Christophe Boucher, citing the “massive” volume of vaccines to be distributed globally.

“Another difficulty is the temperature control,” Boucher said in an interview at Paris-Charles de Gaulle airport – where cargo specialists were preparing to load consignments of super-cooled rabies vaccines bound for Brazil.

The COVID-19 airlift is being planned amid a partial shutdown of global air travel. Airlines have warned that travel curbs could hamper the effort, since around 45% of global cargo typically travels in passenger plane holds.

Air France-KLM does not rule out bringing idled jets back into service for the vaccine shipments, pharma cargo manager Florent Gand said. “We have some planes currently grounded that we can use if necessary to transport the COVID-19 vaccines around the world.”

(Reporting by Noemie Olive and Laurence Frost; Editing by Mark Potter)