Tag Archives: pfizer

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)

Pfizer to start pilot delivery program for its COVID-19 vaccine in four U.S. states

(Reuters) – Pfizer Inc. has launched a pilot delivery program for its experimental COVID-19 vaccine in four U.S. states, as the U.S. drugmaker seeks to address distribution challenges facing its ultra-cold storage requirements.

Pfizer’s vaccine, which was shown to be more than 90% effective in preventing COVID-19 based on initial data, must be shipped and stored at -70 degrees Celsius (minus 94°F), significantly below the standard for vaccines of 2-8 degrees Celsius (36-46°F).

“We are hopeful that results from this vaccine delivery pilot will serve as the model for other U.S. states and international governments, as they prepare to implement effective COVID-19 vaccine programs,” Pfizer said in a statement on Monday.

It picked Rhode Island, Texas, New Mexico, and Tennessee for the program after taking into account their differences in overall size, diversity of populations, immunization infrastructure, and need to reach individuals in varied urban and rural settings.

The four states will not receive vaccine doses earlier than other states by virtue of the pilot, nor will they receive any differential consideration, Pfizer said.

The company expects to have enough safety data on the vaccine from the ongoing large scale late-stage trials by the third week of November before proceeding to apply for emergency use authorization (EUA).

Pfizer and its partner BioNTech SE have a $1.95 billion deal to supply 100 million doses of the vaccine to the U.S. government, which has an option to acquire up to an additional 500 million doses.

Earlier on Monday, rival Moderna Inc. said its experimental vaccine was 94.5% effective in preventing COVID-19 based on interim data from a late-stage trial, boosting hopes that vaccines against the disease may be ready for use soon.

Both the Pfizer and Moderna vaccines use a new technology called synthetic messenger RNA to activate the immune system against the virus.

(Reporting by Shubham Kalia in Bengaluru; Editing by Anil D’Silva and Richard Pullin)

Breakthrough COVID vaccine tech could help defeat other diseases

By John Miller and Ludwig Burger

ZURICH/FRANKFURT (Reuters) – Breakthrough technology that transforms the body into a virus-zapping vaccine factory is poised to revolutionize the fight against COVID-19 but future pandemics and even cancer could be next, scientists say. The initial success of so-called messenger ribonucleic acid (mRNA) vaccines in late-stage trials by Moderna as well as Pfizer and its German partner BioNTech is the first proof the concept works.

Both experimental vaccines had efficacy rates above 90% based on interim findings, which was far higher than expected and well above the 50% threshold U.S. regulators insist upon for vaccines.

Now scientists say the technology, a slow-motion revolution in the making since the discovery of mRNA nearly 60 years ago, could speed up the development of new vaccines.

The traditional method of creating vaccines – introducing a weakened or dead virus, or a piece of one, to stimulate the body’s immune system – takes over a decade on average, according to a 2013 study. One pandemic flu vaccine took over eight years while a hepatitis B vaccine was nearly 18 years in the making.

Moderna’s vaccine went from gene sequencing to the first human injection in 63 days.

With BioNTech and Pfizer’s COVID-19 candidate on a similar trajectory, both could win regulatory approval this year, barely 12 months since the coronavirus first emerged.

Other companies are pursuing the technology such as Germany’s CureVac also has an mRNA vaccine candidate, though has yet to start a late-stage trial and is hoping it will get the green light after July 2021. “We’ll look back on the advances made in 2020 and say: ‘That was a moment when science really did make a leap forward’,” said Jeremy Farrar, director of the Oxford University Clinical Research Unit, which is backed by the Wellcome Trust.

THE LAST LAUGH

Discovered in 1961, mRNA carries messages from the body’s DNA to its cells, telling them to make the proteins needed for critical functions, such as coordinating biological processes like digestion or fighting disease.

The experimental vaccines from Moderna as well as Pfizer and BioNTech use lab-made mRNA to instruct cells to make the coronavirus’s spike proteins, which spur the immune system into action without replicating like the actual virus. Back in 1990, scientists managed to get mice to generate proteins by injecting mRNA, an early sign of the technology’s potential.

But early proponents such as Katalin Kariko, a Hungarian-born scientist and senior vice president at BioNTech, were hampered by obstacles such as mRNA’s instability in the body and its propensity to cause inflammatory responses.

A breakthrough came around 2005 when Kariko, along with colleagues at the University of Pennsylvania, figured out how to deliver mRNA without kicking the immune system into overdrive.

Still, it took another 15 years – and a pandemic that brought the world’s economy to its knees – to reach the cusp of success. Kariko said her years of dogged pursuit once made her the butt of jokes for some university colleagues.

“The last time they laughed at me and ridiculed me was when they learned that I was going to join BioNTech seven years ago and they realized this company (didn’t) even have a website,” she told Reuters. “But now, they learn of BioNTech and that we can do good things.”

Kariko said her life’s work could pay dividends, not just against COVID-19, but other diseases.

“It could be easier sailing for the next anti-viral product, a vaccine for influenza and other infectious disease,” said Kariko, whose daughter is a U.S. Olympic gold medalist rower.

CANCER NEXT?

Moderna and BioNTech, for example, are also applying mRNA technology to experimental cancer medicines.

BioNTech is testing an anti-melanoma mRNA with Swiss pharmaceutical giant Roche in a Phase II trial.

Among Moderna’s most advanced projects, besides its COVID-19 vaccine, are mRNA compounds to treat ovarian cancer or Myocardial ischemia, which are also in the second test phase.

None of the potential mRNA cancer therapies have reached the critical large-scale Phase III trials, however, and Kariko acknowledges that cancer presents a bigger challenge.

While a virus is a foreign intruder, cancer cells, however malignant, come from within the body, making them tougher to seek out and expose so they can be attacked.

“Sometimes cancer is just caused by gene and chromosome duplication and then everything about it looks normal and the cell is just dividing more than it should,” she said.

For vaccines against infectious diseases, the pharmaceutical industry’s traditional approach has been to whip them up in large bioreactors, a time-consuming, expensive process in facilities that can cost up to $700 million to build.

By contrast, Zoltan Kis, an Imperial College London researcher who models vaccine manufacturing, estimates that one five-liter bioreactor inside a $20 million facility could make a billion doses of some kinds of mRNA vaccines a year.

Drug manufacturer Lonza, enlisted to make ingredients for 400 million doses of Moderna’s vaccine annually at U.S. and Swiss sites, is due to start production this year with manufacturing lines costing $60 million to $70 million each.

“We are producing mRNA at smaller scales and in smaller facilities when compared to traditional larger-scale equipment and facilities,” Andre Goerke, Lonza’s global lead for the Moderna project, told Reuters. “The manufacturing ramp-up is quicker and more economical.”

‘ULTRA-FAST RESPONSE’

Raymond Schiffelers, of University Medical Center Utrecht in the Netherlands, who heads a European Union program for mRNA therapeutics, said the major advantage of the technology was that vaccine developers could mount an “ultra-fast response”.

“Within weeks, testing can start, a major advantage over conventional vaccines,” he said.

The moment a pathogen’s genomic sequence is known, synthetic mRNAs can be designed that encode key parts of the virus, such as the coronavirus’s potentially lethal spike protein.

Risks and challenges for mRNA remain.

Some candidates must be stored at extremely cold temperatures, making delivery potentially difficult in countries with limited infrastructure. They also may be fragile to transport, Schiffelers said.

BioNTech’s vaccine, for example, must be transported at minus 70 degrees Celsius, though Moderna said on Monday it can ship its candidate in normal refrigerators.

Francis Collins, director of the U.S. National Institutes of Health (NIH), which funded Moderna’s vaccine development, also said mRNA vaccines may not be a silver bullet for flu, since it mutates so swiftly that reaching 90% efficacy is unlikely.

But for COVID-19, Collins said mRNA is likely to be a revolution.

“It’s clearly several months faster than any of the other methods,” Collins said. “In a crisis moment, several months really matter.”

(Reporting by John Miller in Zurich, Allison Martell in Toronto, Ludwig Burger in Frankfurt, Kate Kelland in London, Michael Erman in New York, Julie Steenhuysen in Chicago and Marton Dunai in Budapest; Editing by Josephine Mason and David Clarke)

Moderna vaccine is second to exceed expectations; mutated virus may be more vulnerable to new vaccines

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.

Vaccine from Moderna is second to exceed expectations in pivotal trial

Moderna Inc’s experimental vaccine was 94.5% effective in preventing COVID-19 based on interim data from a late-stage trial, the company said on Monday. That followed last week’s news that Pfizer Inc’s vaccine was also more than 90% effective based on initial data. Pending more safety data and regulatory review, the United States could have two vaccines authorized for emergency use in December. Both vaccines employ synthetic messenger RNA (mRNA), which coaxes cells to make certain virus proteins that the immune system sees as a threat and mounts a response against. Moderna’s trial involved 30,000 racially diverse U.S. adults, including people at high risk for severe COVID-19. Only five of the 95 COVID-19 cases in the initial analysis occurred in participants who received the vaccine, while the rest had received a placebo. The vaccine, administered in two shots 28 days apart, also appeared to prevent cases of severe COVID-19. Side effects, largely occurring after the second shot, included muscle aches, fever, headache and redness at the injection site. Moderna’s vaccine does not need ultra-cold storage like Pfizer’s, making it easier to distribute. Moderna expects it to be stable at normal refrigerator temperatures of 2 to 8 degrees Celsius (36 to 48°F) for 30 days and can be stored for up to 6 months at -20C.

Mutated virus may be more vulnerable to new vaccines

The mutated form of the new coronavirus that is now the most common strain worldwide is more infectious but may also be more vulnerable to vaccines under development, new research suggests. In experiments reported on Thursday in Science, researchers saw that the newer strain, which originated in Europe, is more efficient at infecting airway cells and at making copies of itself, although it does not appear to produce more severe illness. The D614G mutation causes a “flap” to open on the tip of a spike on the surface of the virus, improving its ability to break into cells, but also creating a pathway for antibodies in vaccines to enter the virus and disable it, the researchers explained in a statement. New SARS-CoV-2 mutations are continually emerging, “like the recently discovered mink SARS-CoV-2 cluster 5 variant in Denmark that also encodes D614G,” coauthor Ralph Baric of the University of North Carolina School of Medicine said in the statement. “We must continue to track and understand the consequences of these new mutations on disease severity, transmission, host range and vulnerability to vaccine-induced immunity,” he added.

Paper forms pose coronavirus risk for lab staff

When laboratory personnel are processing COVID-19 tests, there is a small risk that the paper forms accompanying the specimens can be contaminated with the new coronavirus, a new report cautions. Researchers at the Birmingham Public Health Laboratory in the UK analyzed randomly selected paper forms and specimen packaging during a period when the team was processing about 700 COVID-19 tests daily. Of the 37 items they tested, one piece of paperwork carried genetic material from the coronavirus. The form had come from a low-risk hospital ward, and the specimen from the patient was negative for the virus, “indicating contamination may be occurring as a result of environmental or healthcare worker contamination,” the researchers wrote on Thursday in the Journal of Hospital Infection. They call for “stringent laboratory practices” – hand hygiene, appropriate personal protective equipment – and “use of electronic test requesting where possible.”

(Reporting by Nancy Lapid, Julie Steenhuysen and Michael Erman; Editing by Bill Berkrot)

Fauci not advising Biden, sees no reason to quit Trump now: Reuters interview

By Julie Steenhuysen

CHICAGO (Reuters) – Dr. Anthony Fauci, the top U.S. infectious disease expert, said he has had no contact with President-elect Joe Biden’s coronavirus transition team and sees no reason to quit to join that effort when there is so much to do now to fight the surging pandemic.

“I stay in my lane. I’m not a politician. I do public health things,” he said in an interview on Thursday ahead of next week’s Reuters Total Health conference.

Since January, Fauci has served on President Donald Trump’s White House Coronavirus Task Force, a position that has frequently put him at odds with the president, who has sought to downplay the pandemic and focused instead on opening the economy.

“There’s absolutely no reason and no sense at all for me to stop doing something in the middle of a pandemic that is playing a major role in helping us get out of the pandemic,” Fauci said.

His advice for the president-elect, he said, is “exactly the same” as what he is recommending now – social distancing, avoiding crowds, wearing masks, washing hands. “Public health principles don’t change from one month to another or from one administration to another.”

Fauci has served six administrations and came to prominence fighting the AIDS epidemic in the 1980s under President Ronald Reagan.

His “day job” is developing vaccines and therapeutics as director of the National Institute of Allergy and Infectious Diseases, work that is starting to bear fruit.

On Monday, Pfizer Inc and German partner BioNTech SE announced that their experimental coronavirus vaccine was more than 90% effective – significantly higher than most experts had anticipated.

Moderna Inc, a company developing a similar vaccine with support from the White House’s Operation Warp Speed program, is expected to report results from their late-stage vaccine trial in the next week or so.

Both vaccines use messenger RNA (mRNA) technology, an entirely new rapid vaccine platform that uses synthetic genes to trigger an immune response. Older methods typically use some form of inactivated or killed virus particles.

“It was a home run for the Pfizer product, more than 90% – close to 95% – effective. I have every reason to believe that the Moderna product is going to be similar,” Fauci said.

“It’s an almost identical platform to the Pfizer vaccine, so I would not be surprised at all if it was highly effective,” Fauci added.

The next big question about mRNA technology is safety. Fauci took as a good sign the fact that neither the Pfizer trial, which has enrolled more than 43,000 people so far, nor the Moderna trial, which involves 30,000, had to pause to investigate safety issues.

“That’s really good news,” he said. People in both trials will be followed for two years to make sure there are no long-term side effects. Barring that, “I think that the mRNA platform is here to stay,” he predicted.

In spite of the high bar set by the Pfizer vaccine so far, Fauci said he believes there is still “plenty of room for multiple vaccines, even though there may be a modest degree of difference in total efficacy.”

(Reporting by Julie Steenhuysen, Editing by Peter Henderson and Bill Berkrot)

Moderna could begin analyzing COVID-19 vaccine data within days, says Fauci

By Manas Mishra and Dania Nadeem

(Reuters) – Moderna Inc. could have data from a large trial of its experimental COVID-19 vaccine anywhere between “a couple of days” to “a little more than a week”, the top U.S. infectious disease expert said on Wednesday.

A high degree of effectiveness for the vaccine would make sense as it was “almost identical” to the Pfizer shot, Anthony Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases, said at a conference organized by the Financial Times.

“It may not be 95%, it might be 90%, or 96%, or 89%, but it is going to be up there,” he said.

Hopes of the world soon getting an effective vaccine against the virus that has killed over a million people were raised on Monday after Pfizer Inc. said its COVID-19 vaccine was more than 90% effective based on interim trial results.

Moderna, which uses a technology similar to Pfizer’s, said earlier on Wednesday that its November timeline for initial data was on track.

It did not immediately respond to a Reuters request for comment on when it would disclose the data, though the company has said it would publish the data as soon as it is available.

The company would still have to wait for two-month follow up data on safety, which is expected in the second half of this month, before applying for U.S. emergency use authorization.

Earlier in the day, Chief Executive Officer Stephane Bancel said at a Credit Suisse conference the world would have to wait for more data to understand whether the use of a particular vaccine would be more widespread.

There are no vaccines that have gained global approval yet, although a handful, including Moderna’s, are in late-stage studies.

Moderna’s shares were up roughly 7% at $81.25 in afternoon trading.

(Reporting by Manojna Maddipatla, Manas Mishra and Dania Nadeem in Bengaluru; Editing by Saumyadeb Chakrabarty and Sriraj Kalluvila)

Russia says its Sputnik V COVID-19 vaccine is 92% effective

By Polina Ivanova

MOSCOW (Reuters) – Russia’s Sputnik V vaccine is 92% effective at protecting people from COVID-19 according to interim trial results, the country’s sovereign wealth fund said on Wednesday, as Moscow rushes to keep pace with Western drugmakers in the race for a shot.

Russia’s results are only the second from a late-stage human trial, following on swiftly from data released on Monday by Pfizer Inc. and BioNTech, which said their shot was also more than 90% effective.

While experts said the Russian data was encouraging and reinforced the idea the pandemic could be halted by vaccines, they warned that the results were only based on a small number of trial volunteers who had contracted COVID-19.

The analysis was conducted after 20 participants developed the virus and examined how many had received the vaccine versus a placebo. That is significantly lower than the 94 infections in the trial of the vaccine being developed by Pfizer and BioNTech.

“I assume there was political pressure after the press release from Pfizer and BioNTech earlier in the week to now draw level with their own data,” said Bodo Plachter, deputy director of the Institute of Virology at the Mainz University. “What is missing for now is an analysis of statistical significance.”

To confirm the efficacy rate of its vaccine, Pfizer said it would continue its trial until there were 164 COVID-19 cases.

The Russian Direct Investment Fund (RDIF), which has been backing Sputnik V’s development, said the Russian trial would continue for six months.

Alexander Gintsburg, director of the Gamaleya Institute which developed the vaccine, said the interim results demonstrated that Sputnik V was effective and mass vaccinations would be rolled out in Russia in the coming weeks.

European stocks and U.S. stock futures extended their gains slightly after Russia’s announcement though the reaction was far more muted than after Pfizer’s results.

China’s Sinopharm, which is running large-scale late-stage clinical trials for two COVID-19 vaccine candidates, said on Wednesday that its data was better than expected, though it did not give further details.

‘NOT A COMPETITION’

Successful vaccines are seen as crucial to restoring daily life around the world by helping end the pandemic that has killed more than 1.26 million people, shuttered businesses and put millions out of work.

However, experts said knowledge about the Russian trial’s design was sparse, making it hard to interpret the data.

Scientists have raised concerns about the speed at which Moscow has worked, giving the regulatory go-ahead for the shot and launching mass vaccinations before full trials to test its safety and efficacy had been completed.

“This is not a competition. We need all trials to be carried out to the highest possible standards and it is particularly important that the pre-set criteria for un-blinding the trial data are adhered to avoid cherry picking the data,” said Eleanor Riley, a professor of immunology and infectious disease at the University of Edinburgh.

“Anything less than this risks a public loss of trust in all vaccines, which would be a disaster.”

The results are based on data from the first 16,000 trial participants to receive both shots of the two-dose vaccine.

“We are showing, based on the data, that we have a very effective vaccine,” said RDIF head Kirill Dmitriev, adding that it was the sort of news that the vaccine’s developers would talk about one day with their grandchildren.

The so-called Phase III trial of the shot is taking place in 29 clinics across Moscow and will involve 40,000 volunteers in total, with a quarter receiving a placebo shot.

The chances of contracting COVID-19 were 92% lower among people vaccinated with Sputnik V than those who received the placebo, the RDIF said.

That’s well above the 50% effectiveness threshold for COVID-19 vaccines set by the U.S. Food and Drug Administration.

The RDIF said data from the study would be published in a leading medical journal following a peer review. The results of the early-stage Russian trials were peer reviewed and published in September in The Lancet medical journal.

Experts said that as with the Pfizer results, it was not yet clear how long immunity would last after taking the Russian vaccine, nor how efficient it would be for different age groups.

“We certainly need longer-term observations to draw valid conclusions about efficacy and side effects. The same goes for Pfizer’s and BioNTech’s numbers,” said Plachter in Mainz.

As Moscow seeks partners abroad to boost output, China’s Tibet Rhodiola Pharmaceutical Holding announced a deal soon after the results to released to make, sell and test the shot in China.

SPUTNIK V

The Russian drug is named Sputnik V after the Soviet-era satellite that triggered the space race, a nod to the project’s geopolitical importance for Russian President Vladimir Putin.

Russia registered the vaccine for public use in August, the first country to do so, ahead of the start of the large-scale trial in September.

So far, it has inoculated 10,000 members of the public considered at high risk of contracting COVID-19 such as doctors and teachers, outside of the trial.

The vaccine is designed to trigger a response from two shots administered 21 days apart, each based on different viral vectors that normally cause the common cold: human adenoviruses Ad5 and Ad26.

The Pfizer and BioNTech vaccine uses messenger RNA (mRNA) technology and is designed to trigger an immune response without using pathogens, such as actual virus particles.

Russia is also testing a different vaccine, produced by the Vector Institute in Siberia, and is on the cusp of registering a third, Putin said on Tuesday, adding that all of the country’s vaccines were effective.

RDIF said as of Nov. 11 no serious side effects had been reported during the Sputnik V Phase III trial.

Some volunteers had short-term minor adverse events such as pain at the injection site, flu-like syndrome including fever, weakness, fatigue, and headache, it said.

In late October, the vaccination of new volunteers was temporarily paused due to high demand and a shortage of doses.

Russia’s deputy prime minister said on Wednesday that the Vector Institute vaccine was expected to start post-registration trials on Nov. 15.

She also said that Russia would produce 500,000 doses of Sputnik V in November, lower than a previous forecast of 800,000 doses given by Trade and Industry Minister Denis Manturov.

Russia reported 19,851 new coronavirus infections in the past 24 hours and a record high of 432 deaths. At 1,836,960, its overall case tally is the fifth largest in the world, behind the United States, India, Brazil and France.

(Reporting by Polina Ivanova; Additional reporting by Kate Kelland, Ludwig Burger, Josephine Mason and Thyagaraju Adinarayan; Editing by David Clarke)