Tag Archives: Pfizer-BioNTech

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)

In world first, UK approves Pfizer-BioNTech COVID-19 vaccine

By Guy Faulconbridge and Paul Sandle

LONDON (Reuters) – Britain approved Pfizer’s COVID-19 vaccine on Wednesday, jumping ahead of the rest of the world in the race to begin the most crucial mass inoculation program in history with a shot tested in wide-scale clinical trials.

Prime Minister Boris Johnson touted the greenlight from the UK’s medicine authority as a global win and a ray of hope amid a pandemic, though he recognized the logistical challenges of vaccinating an entire country of 67 million.

Britain’s move raised hopes that tide could soon turn against a virus which has killed nearly 1.5 million people, hammered the world economy and upended normal life for billions.

Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) granted emergency use approval to the Pfizer-BioNTech vaccine, which they say is 95% effective in preventing illness, just 23 days since Pfizer published the first data from its final stage clinical trial.

“Fantastic news,” Johnson told parliament, though he cautioned that people should not get too carried away.

“At this stage it is very, very important that people do not get their hopes up too soon about the speed with which we will be able to roll out this vaccine.”

The world’s big powers have been racing for a vaccine for months to begin the long road to recovery, and getting there first may be seen as a coup for Johnson’s government, which has faced criticism over its handling of the crisis.

The approval of a shot for use close to a year since the novel coronavirus emerged in Wuhan, China, is a triumph for science, Pfizer boss Albert Bourla and his German biotechnology partner BioNTech.

Both the United States and the European Union’s regulator are sifting through the same Pfizer vaccine trial data, but have not yet given their approval.

Britain’s breakneck speed drew criticism from Brussels where, in an unusually blunt statement, the EU’s drugs regulator said its longer procedure was more appropriate as it was based on more evidence and required more checks.

British leaders said that, while they would love to get a shot themselves, priority had to be given to those most in need – the elderly, those in care homes and health workers.

Amid the celebratory rhetoric, Germany’s ambassador to Britain Andreas Michaelis publicly scolded a British minister for presenting it as a national triumph.

“I really don’t think this is a national story. In spite of the German company BioNTech having made a crucial contribution, this is European and transatlantic,” Michaelis said.

‘NO CORNERS CUT’

The U.S. drugmaker said Britain’s emergency use authorization marked a historic moment in the fight against COVID-19. Pfizer announced its vaccine breakthrough on Nov. 9 with stage III clinical trial results.

“This authorization is a goal we have been working toward since we first declared that science will win, and we applaud the MHRA for their ability to conduct a careful assessment and take timely action to help protect the people of the UK,” said CEO Bourla.

Britain’s medicines regulator approved the vaccine in record time by doing a “rolling” concurrent analysis of data and the manufacturing process while Pfizer raced to conclude trials.

“No corners have been cut,” MHRA chief June Raine said in a televised briefing from Downing Street, adding that the first data on the vaccine had been received in June and undergone a rigorous analysis to international standards. “Safety is our watchword.”

“With 450 people dying of COVID-19 infection every day in the UK, the benefits of rapid vaccine approval outweigh the potential risks,” said Andrew Hill, senior visiting research fellow in the Department of Pharmacology at the University of Liverpool.

The U.S. Food and Drug Administration (FDA) will make a decision on emergency use authorization on the Pfizer/BioNTech vaccine in days or weeks after a panel of outside advisors meets on Dec. 10 to discuss whether to recommend it. The FDA often but not always follows the panel’s advice.

The European Medicines Agency (EMA) said it could give emergency approval for the shot by Dec. 29.

“The data submitted to regulatory agencies around the world are the result of a scientifically rigorous and highly ethical research and development program,” said Ugur Sahin, chief executive and co-founder of BioNTech.

BioNTech said it expected FDA and EMA to make a decision in mid-December.

Anti-poverty campaigners, meanwhile, warned against rich countries hoarding vaccines at the expense of poorer ones. “The worst thing we can do at this moment is allow a small number of countries to monopolize access to vaccines like this,” said Romilly Greenhill, UK director of the ONE organization.

FIRST IN LINE?

Britain said it would start vaccinating those most at risk of dying early next week after it gets 800,000 doses from Pfizer’s manufacturing center in Belgium.

“I strongly urge people to take up the vaccine but it is no part of our culture or our ambition in this country to make vaccines mandatory,” Johnson said.

The speed of the rollout depends on how fast Pfizer can manufacture and deliver the vaccine – and the extreme temperature of -70C (-94F) at which the vaccine must be stored.

Britain has ordered 40 million doses of the Pfizer vaccine – enough for just under a third of the population as two shots are needed per person to gain immunity.

Health Secretary Matt Hancock said hospitals were ready to receive the shots and vaccination centers would be set up across the country, but he admitted distribution would be a challenge given storage at temperature typical of an Antarctic winter.

Pfizer has said the shots can be kept in thermal shipping boxes for up to 30 days. Afterwards, the vaccine can be kept at fridge temperatures for up to five days.

Other frontrunners in the vaccine race include U.S. biotech firm Moderna, which has said its shot was 94% successful in late-stage clinical trials, and AstraZeneca, which said last month its COVID-19 shot was 70% effective in pivotal trials and could be up to 90% effective.

(Reporting by Guy Faulconbridge and Paul Sandle; Additional reporting by Kate Kelland, Alistair Smout and Estelle Shirgon; Editing by Kate Holton, Carmel Crimmins, Alex Richardson and Nick Macfie)

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)