Tag Archives: Anthony Fauci

U.S. CDC recommends vaccinated Americans wear masks indoors in many cases

By David Shepardson and Julie Steenhuysen

WASHINGTON (Reuters) -Americans fully vaccinated against COVID-19 should go back to wearing masks in indoor public places in regions where the coronavirus and especially the Delta variant are spreading rapidly, U.S. authorities said on Tuesday.

The U.S. Centers for Disease Control and Prevention (CDC) also recommended all students and teachers at kindergarten through 12th grade schools wear masks regardless of vaccination status. The CDC said children should return to full-time, in-person learning in the fall with proper prevention strategies.

The changes mark a reversal of the CDC’s announcement in May that prompted millions of vaccinated Americans to shed their face coverings.

The United States leads the world in the daily average number of new infections, accounting for one in every nine cases reported worldwide each day. The seven-day average for new cases has been rising sharply and stands at 57,126, still about a quarter of the pandemic peak.

“In areas with substantial and high transmission, CDC recommends that fully vaccinated individuals wear a mask in public indoor settings to help prevent spread of Delta and protect others,” the agency said.

The CDC said that 63% of U.S. counties had high transmission rates that warranted mask wearing. The Delta variant is highly transmissible.

In May, the agency advised that fully vaccinated people do not need to wear masks outdoors and can avoid wearing them indoors in most places, guidance the agency said would allow life to begin to return to normal.

Dr. David Doudy, an epidemiologist at Johns Hopkins University, said the CDC guidance was motivated by a change in infection patterns. “We’re seeing this doubling in the number of cases every 10 days or so,” he said.

‘A NECESSARY PRECAUTION’

American Federation of Teachers President Randi Weingarten praised the new CDC mask guidance in a statement, saying it was needed “to deal with the changing realities of virus transmission.”

She called it “a necessary precaution until children under 12 can receive a COVID vaccine and more Americans over 12 get vaccinated.”

The new CDC recommendations are not binding and many Americans, especially in Republican-leaning states, may choose not to follow them. At least eight states bar schools from requiring masks.

Dr. Isaac Weisfuse, a medical epidemiologist and adjunct professor at Cornell University Public Health, said resistance was likely among some people. “I think we will get blowback because I think people might view it as backtracking,” he said.

On Monday, the Biden administration confirmed it will not lift any existing international travel restrictions, citing the rising number of COVID-19 cases and the expectation that they will continue to rise in the weeks ahead.

Masks became a political issue in the United States under former President Donald Trump, who resisted mandating face coverings. President Joe Biden has embraced masks and mandated them for transit hubs days after taking office.

(Reporting by David Shepardson; Additional reporting by Nandita Bose; Editing by Rosalba O’Brien, Bill Berkrot and Cynthia Osterman)

U.S. vaccinated 600,000 12-15 year old’s last week

By Carl O’Donnell

(Reuters) -The United States administered COVID-19 vaccinations to around 600,000 children ages 12 to 15 last week after regulators cleared Pfizer Inc’s and BioNTech’s shots for use in that age group, U.S. Centers for Disease Control and Prevention Director Rochelle Walensky said in a media call on Tuesday.

In total, more than 4 million people under 17 have been vaccinated in the United States so far, she added. Top U.S. infectious disease specialist Anthony Fauci said he expects that by the end of 2021 the United States will have enough safety data to vaccinate children of any age.

U.S. regulators last week authorized Pfizer’s COVID-19 vaccine for use in children as young as 12. Most states began issuing shots to children last Thursday but some, including Georgia, started sooner.

Pfizer’s shot is the first to be cleared in the United States for children 12 to 15. Vaccinating younger ages is considered important for getting children back into schools safely. U.S. President Joe Biden has asked states to make the vaccine available to younger adolescents immediately.

The vaccine has been available under an emergency use authorization to people as young as 16 in the United States since December.

Most children with COVID-19 develop only mild symptoms or no symptoms. Yet children remain at risk of becoming seriously ill, and they can spread the virus.

Widely vaccinating 12- to 18-year old’s could allow U.S. schools and summer camps to relax masking and social distancing measures suggested by the CDC.

Fauci also said on Tuesday that existing COVID-19 shots probably also protect against the new variant of the coronavirus first found in India, which has been battling the world’s biggest jump in COVID-19 infections.

(Reporting by Carl O’Donnell, additional reporting by Jeff Mason; Editing by Chizu Nomiyama and David Gregorio)

U.S. likely to start COVID-19 vaccination in children by late spring or early summer – Fauci

(Reuters) – The United States will likely start vaccinating children by late spring or early summer, top U.S. infectious disease expert Anthony Fauci said on Friday, as studies are underway to test the safety and effectiveness of Pfizer Inc and Moderna Inc’s COVID-19 vaccines in children under 16.

“Over the next couple of months, we will be doing trials in an age de-escalation manner so that hopefully by the time we get to the late spring and early summer we will have children being able to be vaccinated according to the FDA guidance,” Fauci said, speaking at a White House press briefing.

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

J&J adds to COVID-19 vaccine armory with 66% efficacy in global trial

By Julie Steenhuysen

(Reuters) – Johnson & Johnson said on Friday that its single-dose vaccine was 66% effective in preventing COVID-19 in a large global trial against multiple variants which will give health officials another weapon to tackle the coronavirus.

In the trial of nearly 44,000 volunteers, the level of protection against moderate and severe COVID-19 varied from 72% in the United States, to 66% in Latin America and just 57% in South Africa, from where a worrying variant has spread.

A high bar has been set by two authorized vaccines from Pfizer/BioNTech and Moderna, which were around 95% effective in preventing symptomatic illness in pivotal trials when given in two doses.

Those trials, however, were conducted mainly in the United States and before new variants emerged.

The top U.S. infectious disease specialist Anthony Fauci said the variations in effectiveness around the world underlined the need to vaccinate as many people as quickly as possible to prevent new variants from emerging.

“It’s really a wake up call for us to be nimble and to be able to adjust as this virus will continue for certain to evolve,” Fauci said.

J&J’s main goal was the prevention of moderate to severe COVID-19, and the vaccine was 85% effective in stopping severe disease and preventing hospitalization across all geographies and against multiple variants 28 days after immunization.

That “will potentially protect hundreds of millions of people from serious and fatal outcomes of COVID-19,” Paul Stoffels, J&J’s chief scientific officer, said of the results, which were based on 468 symptomatic cases.

SEEKING APPROVAL

J&J plans to seek emergency use authorization from the U.S. Food and Drug Administration next week. It has said it plans to deliver 1 billion doses in 2021 and will produce the vaccine in the United States, Europe, South Africa and India.

Public health officials are counting on the J&J vaccine to increase much-needed supply and simplify immunization in the United States, which has a deal to buy 100 million doses of J&J’s vaccine and an option for an additional 200 million.

J&J said the vaccine would be ready immediately upon emergency approval, but Stoffels declined to say how many doses.

“Right now, any protection and additional vaccine is great. The key is not only overall efficacy but specifically efficacy against severe disease, hospitalization, and death,” Walid Gellad, a health policy associate professor at the University of Pittsburgh, said.

Michael Breen, Director of Infectious Diseases and Ophthalmology at research firm GlobalData said “Most countries are still desperate to get their hands on doses, regardless of whether or not the vaccine is considered highly effective. Moderately effective will do just fine for now.”

None of the vaccine recipients in the J&J trial died from COVID-19, compared with 5 in the placebo group, the National Institutes of Health said. Three deaths in the vaccine group overall, but none were determined to be from the virus. That compares with 16 deaths overall in the placebo arm, it added.

Unlike the Pfizer and Moderna vaccines, J&J’s does not require a second shot weeks after the first or need to be kept frozen, making it a strong candidate for use in parts of the world where transportation and cold storage are an issue.

SOUTH AFRICAN VARIANT

Several studies have emerged this month showing that a South African variant has mutated in areas of the virus that are key targets of vaccines, reducing their efficacy.

“What we are learning is there is different efficacy in different parts of the world,” Stoffels told Reuters.

In a sub-study of 6,000 volunteers in South Africa, Stoffels said, the J&J vaccine was 89% effective at preventing severe disease. In the South Africa portion of the trial, 95% of cases were infections with the South African variant.

“I am overwhelmed by the fact that this vaccine protected against severe disease even in South Africa,” said Glenda Gray, the joint lead investigator of the South African vaccine trial.

Gray, who is the chief executive of the South African Medical Research Council, said this is by far the best vaccine for South Africa to fight the mutant strain and can prevent a large number of hospitalizations and deaths.

A mid-stage trial of a Novovax coronavirus vaccine in South Africa also showed lower efficacy, proving to be 60% effective among volunteers who didn’t have HIV. In a separate, late-stage trial in Britain it was 89.3% effective.

In the J&J trial, which was conducted in eight countries, 44% of participants were from the United States, 41% from Central and South America and 15% from South Africa. Slightly more than a third of the volunteers were over 60.

J&J’s vaccine uses a common cold virus to introduce coronavirus proteins into cells in the body and trigger an immune response, whereas the Pfizer/BioNTech and Moderna vaccines use a new technology called messenger RNA (mRNA).

(Reporting by Julie Steenhuysen; Additional reporting by Manas Mishra, Dania Nadeem and Manojna Maddipatla in Bengalaru and Rebecca Spalding and Michael Erman in New York; Writing by Alexander Smith; Editing by Caroline Humer, Peter Henderson, Edwina Gibbs and Keith Weir)

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)

Alarmed by soaring COVID-19 hospitalizations, some U.S. states tighten curbs

By Sharon Bernstein and Maria Caspani

SACRAMENTO (Reuters) – Several U.S. states on Tuesday imposed restrictions to curb the spread of the coronavirus as hospitalizations soared, straining hospitals and medical resources across much of the country.

The number of patients hospitalized with COVID-19 in California has risen by 32% over the past two weeks, and intensive-care admissions have spiked by 30%, Dr. Mark Ghaly, the state’s health and human services secretary, told reporters.

As a result, Ghaly announced that three counties that are home to about 5.5 million people – San Diego, Sacramento and Stanislaus – must reverse their reopening plans and go back to the most restrictive category of regulations under which indoor dining in restaurants is not allowed and gyms and religious institutions are also not permitted to hold indoor activities.

“We anticipate if things stay they way they are … over half of California counties will have moved into a more restrictive tier” by next week, Ghaly said.

In Minnesota, Governor Tim Walz announced new restrictions as the Midwestern state reported a fresh record high in daily COVID-19 hospitalizations, and medical systems in Minnesota expressed concerns about their ability to cope with the surge.

The state reported 1,224 coronavirus hospitalizations on Tuesday, up from 1,084 the previous day and a new daily record, according to a Reuters tally.

Beginning Friday, restaurants and bars in Minnesota must close dine-in services between 10 p.m. and 4 a.m., and keep the number of patrons below 50% of capacity. The governor’s order also includes private social gatherings, which must be limited to 10 people from three households or less.

“We’ve turned our dials, we’re going to have to turn them back a little bit today,” Walz told a briefing.

In Illinois, which recorded its highest number of daily cases on Tuesday with 12,626 new infections, Governor J.B. Pritzker told reporters the majority of the state’s regions were seeing higher hospitalization rates than last spring.

Faced with rampant coronavirus infections and a strained healthcare system, Iowa Governor Kim Reynolds also took steps to curb the disease’s spread by limiting the size of social gatherings and imposing a targeted mask-wearing requirement for certain situations.

U.S. Health Secretary Alex Azar expressed concern about rising hospitalizations that were straining medical facilities in areas hardest hit by the surge, and said health officials will work to set up temporary medical facilities where they might be needed.

“As you get more cases, you get more hospitalizations,” Azar said in an interview with MSNBC. “It’s just simple math.”

There were just over 59,000 COVID-19 patients in hospitals across the United States on Monday, the country’s highest number ever of in-patients being treated for the disease. Daily new infections exceeded 100,000 for the sixth consecutive day.

Hospitalizations are a key metric of how the pandemic is progressing because, unlike case counts, they are not influenced by the number of tests performed.

The harsh statistics tallied by Reuters cemented the United States’ position as the country worst affected by the coronavirus pandemic, even as drugmaker Pfizer Inc. on Monday provided some hope: successful late-stage tests of its vaccine.

U.S. infectious disease expert Anthony Fauci welcomed the Pfizer vaccine announcement but warned the winter months promise to bring more infections as people stay indoors.

Fauci said health officials were reporting more infections from small gatherings, an indication the virus is being spread by asymptomatic people.

“There are people out there, innocently and unwittingly, who are infected, don’t have any symptoms, who are infecting others,” he told MSNBC on Tuesday. “So, much more widespread testing of asymptomatic individuals is going to be very important as we enter, and go into, these months of indoor-type gathering.”

The American Health Care Association and National Center for Assisted Living warned about a spike in COVID-19 cases in nursing homes.

“As we feared, the sheer volume of rising cases in communities across the U.S., combined with the asymptomatic and pre-symptomatic spread of this virus, has unfortunately led to an increase in new COVID cases in nursing homes,” Mark Parkinson, president and chief executive of the American Health Care Association and National Center for Assisted Living, said in a statement.

Nursing homes in the hard-hit Midwest saw a 120% increase in weekly COVID-19 cases since mid-September, the group said.

(Reporting by Doina Chiacu in Washington, Anurag Maan in Bengaluru, Sharon Bernstein in Sacramento, California; additional reporting by Maria Caspani, Peter Szekely and Gabriella Borter in New York; writing by Maria Caspani; editing by Jonathan Oatis)

Split screen: Trump and Biden to headline dueling town halls

By Joseph Ax

(Reuters) – U.S. President Donald Trump and Democratic challenger Joe Biden will hold dueling prime-time town halls on Thursday instead of their second presidential debate, which was canceled after Trump declined to take part in a virtual matchup.

With less than three weeks to go until the Nov. 3 vote, the Republican president is searching for ways to change the dynamics of a race in which Biden has a double-digit advantage in some national polls.

Nearly 15 million Americans, a record for this date, have cast ballots, according to the U.S. Elections Project at the University of Florida, as voters seek to avoid in-person lines on Election Day because of concerns about the novel coronavirus.

North Carolina, a highly competitive state, began more than two weeks of in-person early voting on Thursday. Local news reports showed long lines of voters eager to cast ballots, and Trump was due to hold an afternoon rally in Greenville in the eastern part of the state.

Trump’s campaign is counting on a surge of last-minute votes. But Reuters/Ipsos polling conducted between Oct. 9 and Oct. 13 shows there are far fewer undecided likely voters this year – around 8% – and they are just as likely to pick Biden as they are Trump.

Four years ago at this stage of the campaign, more than twice as many people were similarly wavering between Trump and his Democratic opponent, Hillary Clinton.

The Reuters/Ipsos polling shows Biden holding a 10 percentage-point lead nationally, with a tighter margin in the battleground states that will help decide the election.

Both candidates have been visiting those states this week, with Trump holding rallies in Florida, Pennsylvania and Iowa and Biden traveling to Ohio and Florida.

Trump has pulled into a statistical tie with Biden in Florida, a key battleground, with 47% support versus Biden’s 49%, and a credibility interval of 4 points, a Reuters/Ipsos opinion poll showed.

Thursday’s town halls, in which each candidate will field questions from voters, will take place at 8 p.m. EDT (0000 GMT), with Trump on NBC from Miami and Biden on ABC from Philadelphia.

Trump pulled out of the scheduled debate when the commission in charge of organizing the event said it would be held virtually after the president contracted the coronavirus. A final debate is still scheduled for Oct. 22 in Nashville, Tennessee.

On Thursday, the Biden campaign said two people involved in the campaign had tested positive for COVID-19, including one on the staff of U.S. Senator Kamala Harris, Biden’s running mate.

Although neither Biden nor Harris was in close contact with the people, the campaign said it was cancelling Harris’ travel until after Sunday, “in line with our campaign’s commitment to the highest levels of precaution.”

Trump has returned to the campaign trail after spending several days being treated for the virus in a military hospital.

NBC said on Wednesday that Clifford Lane, clinical director at the National Institutes of Health, and the government’s top infectious disease specialist, Anthony Fauci, had concluded “with a high degree of confidence” that Trump was no longer “shedding infectious virus.”

The election could be the most closely contested in recent memory due to a deeply divided electorate and the possibility that Trump will challenge widely used mail-in ballots, claiming without evidence they are fraudulent.

(Reporting by Trevor Hunnicutt and Chris Kahn in New York and Doina Chiacu and James Oliphant in Washington; Writing by Joseph Ax and Sonya Hepinstall; Editing by Colleen Jenkins and Matthew Lewis)

Defying critics, Trump says Americans are learning to live with COVID-19

By Alexandra Alper and Deena Beasley

WASHINGTON (Reuters) – Defying critics, U.S. President Donald Trump on Tuesday said Americans were learning to live with COVID-19, a day after returning to the White House for further intensive treatment after being hospitalized with the coronavirus.

Trump, who returned late on Monday after nearly four days at Walter Reed Medical Center outside Washington, was due to receive a fifth transfusion of the antiviral drug remdesivir while being treated with the steroid dexamethasone, normally used only in the most severe cases.

The Republican president, who is running against Democrat Joe Biden in an election four weeks away, has repeatedly played down the disease, which has killed more than 1 million people worldwide. The United States has the world’s highest death toll from the pandemic, with more than 209,000 deaths.

“Many people every year, sometimes over 100,000, and despite the Vaccine, die from the Flu. Are we going to close down our Country? No, we have learned to live with it, just like we are learning to live with Covid, in most populations far less lethal!!!” Trump tweeted on Tuesday.

About 22,000 people are estimated to die from influenza in the 2019-2020 season, according to U.S. government statistics. Even before he contracted COVID-19, Trump acknowledged in taped conversations with a journalist that the disease was deadlier than the flu.

White House physician Dr. Sean Conley has also stressed Trump would have world-class medical care available around the clock, something many health experts have noted is unavailable to millions of other Americans.

“Don’t let it dominate you. Don’t be afraid of it,” Trump said in a video after his return on Monday night.

“I’m better, and maybe I’m immune – I don’t know,” he added, flanked by American flags and with the Washington Monument in the background. “Get out there. Be careful.”

He returned to the White House in a made-for-television spectacle, descending from his Marine One helicopter wearing a white surgical mask, only to remove it as he posed, saluting and waving, on the mansion’s South Portico.

Trump has repeatedly flouted social-distancing guidelines meant to curb the virus’ spread and ignored his own medical advisers. He mocked Biden at last Tuesday’s presidential debate for wearing a mask when campaigning.

“I was aghast when he said COVID should not be feared,” said William Schaffner, a professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center in Nashville.

“This is a disease that is killing around a thousand people a day, has torpedoed the economy, put people out of work. This is a virus that should be both respected and feared.”

Democrats also weighed in. “This is a tragic failure of leadership,” Democratic Senator Chris Coons tweeted.

But Trump depicted himself as a man who vanquished the disease and emerged stronger.

“If the President bounces back onto the campaign trail, he will be an invincible hero, who not only survived every dirty trick the Democrats threw at him, but the Chinese virus as well,” he wrote on Twitter.

White House spokesman Judd Deere said every precaution was being taken to protect the president and his family. Physical access to Trump would be limited and appropriate protective equipment would be worn by those near him.

Questions swirled around the true state of Trump’s health after a weekend when his doctors offered contradictory or opaque assessments of his condition.

His oxygen saturation dipped enough to require supplemental oxygen on Friday and Saturday, his doctors said, but have not answered key questions about his lung function, his blood work, or when he lasted tested negative.

SETBACK POSSIBLE

Many aides and confidants have been diagnosed with the disease since his announcement last week that he had tested positive for it, intensifying scrutiny and criticism of the administration’s handling of the pandemic.

Trump had no public events listed for Tuesday and it was unclear when he would be able to resume a full schedule.

“I’m sure he’ll rest the next two days. And he’ll get going as soon as they say it’s OK to get going,” Trump’s personal attorney Rudy Giuliani told Fox News on Tuesday, adding that Trump would still do light work like making phone calls.

“You never know with this disease, but it seems like he is making a very rapid recovery and a strong one. And certainly his spirit is back. He’s raring to go,” Giuliani said.

Republican Senator Thom Tillis, who also tested positive for COVID-19 after a Sept. 26 White House visit, said on Twitter that Trump called him Monday night and said he was “feeling great and working hard.”

After recent opinion polls showed Trump slipping further behind Biden, early voting data indicated that nearly 4 million Americans have already cast ballots four week before election day, suggesting there may be a record turnout.

The severity of Trump’s illness has been the subject of intense speculation, with some experts noting that, as an overweight, elderly man, he was in a high risk category.

#GaspingForAir began trending on Twitter after video showed Trump appearing to take several deep breaths while standing on the White House balcony.

Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, told CNN Trump looked good when he came out of the hospital, but noted that patients sometimes have a setback five days after they get sick.

“Sometimes when you’re five days in you’re going to have a reversal … It’s unlikely that it will happen, but they need to be heads-up (alert) for it,” Fauci said.

(Additional reporting by Alexandra Alper, Doina Chiacu, Ross Colvin, Steve Holland and Mohammad Zargham in Washington and by Deena Beasley in Los Angeles; Writing by Arshad Mohammed; Editing by Ross Colvin, Catherine Evans and Howard Goller)

U.S. CDC tells states to prep for COVID-19 vaccine distribution as soon as late October

By Manojna Maddipatla

(Reuters) – The U.S. Centers for Disease Control and Prevention (CDC) has asked state public health officials to prepare to distribute a potential coronavirus vaccine to high-risk groups as soon as late October, documents published by the agency showed on Wednesday.

The timing of a vaccine has taken on political importance as U.S. President Donald Trump seeks re-election in November, after committing billions of federal dollars to develop a vaccine to prevent COVID-19, which has killed more than 180,000 Americans.

“For the purpose of initial planning, CDC provided states with certain planning assumptions as they work on state specific plans for vaccine distribution, including possibly having limited quantities of vaccines in October and November,” a CDC spokeswoman told Reuters.

The New York Times had earlier reported that the CDC had contacted officials in all 50 states and five large cities with the planning information.

The country’s top infectious disease expert Anthony Fauci earlier on Wednesday said on MSNBC that based on the patient enrollment rate in COVID-19 vaccine trials underway, there could be enough clinical data to know by November or December that one of the vaccines is safe and effective.

The documents put online by the New York Times showed the CDC is preparing for one or two vaccines for COVID-19 to be available in limited quantities as soon as late October.

The vaccines would be made available free of cost first to high-risk groups including healthcare workers, national security personnel, and nursing home residents and staff, the agency said in the documents.

Regulators around the world have repeatedly said development speed will not compromise vaccine safety, as quicker results would stem from conducting parallel trials that are usually done in sequence. But such reassurances have not convinced everyone.

Preliminary results of a survey conducted over the last three months in 19 countries showed that only about 70% of British and U.S. respondents would take a COVID-19 vaccine if available, Scott Ratzan, co-leader of a group called Business Partners to Convince, told Reuters in August.

Drug developers including Moderna Inc., AstraZeneca Plc and Pfizer Inc. are leading the race to develop a safe and effective vaccine for the respiratory illness.

The CDC documents describe two vaccine candidates that must be stored at temperatures of minus 70 and minus 20 degrees Celsius. Those storage requirements match profiles of candidates from Pfizer and Moderna.

Last month, the U.S. health department said the CDC was executing an existing contract option with McKesson Corp. to support potential vaccine distribution.

CDC Director Robert Redfield has asked state governors to expedite McKesson’s requests for building vaccine distribution centers and to consider waiving requirements that would stop them from becoming fully operational by Nov. 1, according to a recent letter obtained by Reuters.

(Reporting by Manojna Maddipatla in Bengaluru and Deena Beasley in Los Angeles; Editing by Maju Samuel, Tom Brown and Subhranshu Sahu)

Next big COVID-19 treatment may be manufactured antibodies

By Deena Beasley

(Reuters) – As the world awaits a COVID-19 vaccine, the next big advance in battling the pandemic could come from a class of biotech therapies widely used against cancer and other disorders – antibodies designed specifically to attack this new virus.

Development of monoclonal antibodies to target the virus has been endorsed by leading scientists. Anthony Fauci, the top U.S. infectious diseases expert, called them “almost a sure bet” against COVID-19.

When a virus gets past the body’s initial defenses, a more specific response kicks in, triggering production of cells that target the invader. These include antibodies that recognize and lock onto a virus, preventing the infection from spreading.

Monoclonal antibodies – grown in bioreactor vats – are copies of these naturally-occurring proteins.

Scientists are still working out the exact role of neutralizing antibodies in recovery from COVID-19, but drugmakers are confident that the right antibodies or a combination can alter the course of the disease that has claimed more than 675,000 lives globally.

“Antibodies can block infectivity. That is a fact,” Regeneron Pharmaceuticals executive Christos Kyratsous told Reuters.

Regeneron is testing a two-antibody cocktail, which it believes limits the ability of the virus’ to escape better than one, with data on its efficacy expected by late summer or early fall. “Protection will wane over time. Dosing is something we don’t know yet,” said Kyratsous.

The U.S. government in June awarded Regeneron a $450 million supply contract. The company said it can immediately begin production at its U.S. plant if regulators approve the treatment.

Eli Lilly and Co, AstraZeneca, Amgen, and GlaxoSmithKline were cleared by the U.S. government to pool manufacturing resources in order to scale up supplies if any of these drugs prove successful.

Even with that unusual cooperation among rivals, manufacturing these medicines is complex and capacity is limited. There is also a debate over whether a single antibody will be powerful enough to stop COVID-19.

AstraZeneca said it plans to start human trials of its dual-antibody combination within weeks.

Lilly, which began human testing in June of two antibody candidates in separate trials, is focusing on a one-drug approach.

“If you need a higher dosage or more antibodies, fewer people can be treated,” Lilly Chief Scientific Officer Dan Skovronsky said.

‘INSTANT IMMUNITY’

Unlike vaccines, which activate the body’s own immune system, the impact of infused antibodies eventually dissipates.

Still, drugmakers say monoclonal antibodies could temporarily prevent infection in at-risk people such as medical workers and the elderly. They could also be used as a therapeutic bridge until vaccines become widely available.

“In a prophylactic setting we think we may achieve coverage for up to six months,” said Phil Pang, chief medical officer of Vir Biotechnology, which aims to start testing an antibody in non-hospitalized patients next month with partner GSK.

“The advantage of an antibody is that it is basically instant immunity,” said Mark Brunswick, senior vice president at Sorrento Therapeutics, which aims to begin human trials next month of a single antibody candidate.

Safety risks for monoclonal antibodies are considered low, but their cost can be quite high. These type of drugs for cancer can cost over $100,000 a year.

There is also concern that the coronavirus could become resistant to specific antibodies. Researchers are already at work on second-generation compounds with targets other than the crown-like spikes the virus uses to invade cells.

“We are trying to develop something that is complementary,” Amgen research chief David Reese said. Amgen is working with Adaptive Biotechnologies Corp.

Researchers in a recent paper published in the journal Nature said they had discovered several new, very potent, antibodies directed to an area where the virus attaches to human cells and to a region of the spike that has not attracted attention.

“To avoid development of resistance you want to target different sites,” study author and Columbia University professor David Ho told Reuters.

There are also questions about when in the course of the illness it might be best to employ these new weapons.

“Giving an antibody later on after infection might not be that helpful, said Florian Krammer, microbiology professor at New York’s Icahn School of Medicine. “Given early, they probably work well.”

(Reporting By Deena Beasley, editing by Peter Henderson and Bill Berkrot)