Tag Archives: Operation Warp Speed

U.S. plans for first COVID vaccines as pandemic deaths surge again

By Julie Steenhuysen and Doina Chiacu

WASHINGTON (Reuters) – Top U.S. health officials announced plans on Tuesday to begin vaccinating Americans against the coronavirus as early as mid-December, as nationwide deaths hit the highest number for a single day in six months.

Some 20 million people could be inoculated against COVID-19 by the end of 2020 and most Americans will have access to highly effective vaccines by mid-2021, the chief adviser of President Donald Trump’s Operation Warp Speed program said.

“Within 24 hours, maybe at most 36 to 48 hours, from the approval, the vaccine can be in people’s arms,” Moncef Slaoui, a former GlaxoSmithKline executive who is overseeing the vaccine portion of the U.S. program, said at an event conducted by The Washington Post newspaper.

His comments came on the same day that another 2,295 fatalities nationwide were linked to COVID-19, even before California, the most populous U.S. state, reported full results. Officials in several states said numbers were higher in part due to a backlog from the Thanksgiving holiday.

A statement from the public health director for Los Angeles County highlighted the ravages of the surging pandemic. Barbara Ferrer, the public health director, said that while Tuesday was the county’s “worst day thus far” of the pandemic, “…it will likely not remain the worst day of the pandemic in Los Angeles County. That will be tomorrow, and the next day and the next as cases, hospitalizations and deaths increase.”

Health officials pleaded with Americans to stick with coronavirus restrictions even with a vaccine in sight.

The U.S. Centers for Disease Control and Prevention is moving to shorten the length of self-quarantine recommended after potential exposure to the coronavirus to 10 days, or seven days with a negative test, a federal spokesperson said on Tuesday. The CDC currently recommends a 14-day quarantine in order to curb the transmission of the virus.

TIMELINE ON A VACCINE

Some 60 million to 70 million doses of COVID-19 vaccine could be available per month beginning in January, after the expected regulatory approval of products from Pfizer Inc and Moderna Inc, Slaoui said.

A Food and Drug Administration panel of outside advisers will meet on Dec. 10 to discuss whether to recommend emergency use authorization of the Pfizer vaccine, developed with German partner BioNTech SE. Moderna’s vaccine candidate is expected to be reviewed a week later.

The timeline described by Slaoui and Health and Human Services Secretary Alex Azar appeared to assume that the FDA’s authorization of the first vaccine would come within days of the Dec. 10 meeting.

But the head of the FDA’s Center for Biologics Evaluation and Research, Dr. Peter Marks, told patient advocacy groups last week that it might take “a few days to a few weeks.”

FDA Commissioner Stephen Hahn, likewise, has said the process could take longer.

The U.S. Transportation Department said on Tuesday it has made preparations to enable the “immediate mass shipment” of COVID-19 vaccines and completed all necessary regulatory measures.

An estimated 21 million healthcare workers and 3 million residents of long-term care facilities should be first in line to receive a vaccine, according to a recommendation voted on by a CDC panel of advisers on Tuesday.

Nursing homes are experiencing the worst outbreak of weekly coronavirus cases since the spring, according to the American Health Care Association and National Center for Assisted Living.

HOLIDAY TRAVEL SPIKE

State and local officials have returned to imposing restrictions on businesses and activities in response to the latest surge of a pandemic that killed 37,000 people in November.

A record nearly 96,000 COVID-19 patients were reported in U.S. hospitals on Tuesday, according to a Reuters tally.

Hospitalizations and deaths are expected to spike even higher during the holiday travel season, a trend that officials warn could overwhelm already strained healthcare systems.

The monthly death toll from COVID-19 is projected to nearly double in December to a pandemic-high of more than 70,000 and surpass 76,000 in January before ebbing in February, according to a widely cited model from the University of Washington’s Institute for Health Metrics and Evaluation.

Pandemic-related restrictions have ravaged the U.S. economy. A bipartisan group of U.S. lawmakers on Tuesday unveiled a $908 billion COVID-19 relief bill aimed at breaking a deadlock over emergency assistance for small businesses, industries and the unemployed.

(Reporting by Doina Chiacu and Julie Steenhuysen; Additional reporting by Lisa Shumaker, Maria Caspani, Peter Szekely, Jonathan Allen, David Shepardson, Steve Gorman and Dan Whitcomb; Writing by Daniel Trotta and Dan Whitcomb; Editing by Bill Berkrot, Bill Tarrant and Leslie Adler)

4.2 million COVID-19 cases in November

WASHINGTON (Reuters) – The United States entered the final month of the year hoping that promising vaccine candidates will soon be approved to halt the rapidly spreading novel coronavirus after 4.2 million new cases were reported in November.

The new COVID-19 cases were more than double the previous monthly record set in October, as large numbers of Americans still refuse to refuse to wear masks and continue to gather in holiday crowds, against the recommendation of experts.

A Food and Drug Administration panel of outside advisers will meet on Dec. 10 to discuss whether to recommend the FDA authorize emergency use of a vaccine developed by Pfizer Inc.

A second candidate from Moderna Inc could follow a week later, officials have said, raising hopes that Americans could start receiving inoculations before the end the year, although widespread vaccinations could take months.

Other global pharmaceuticals including AstraZeneca PLC and Johnson & Johnson also have vaccines in the works, leading a member of the Trump administration’s “Operation Warp Speed” program to predict the country could be vaccinated by June.

“One hundred percent of the Americans that want the vaccine will have the vaccine by (June). We will have over 300 million doses available to the American public well before then,” Paul Ostrowski, the vaccine program’s director of supply, production and distribution, told MSNBC television on Monday.

In the meantime, leading health officials are pleading with Americans to follow their recommendations and help arrest a pandemic that killed more than 36,000 people in November, pushing hospitalizations to a record high of nearly 93,000 on Sunday, according to a Reuters tally.

The widespread impact of the pandemic has led Merriam-Webster to choose “pandemic” as the Word of the Year after it racked up the most online dictionary lookups of any word.

“Sometimes a single word defines an era, and it’s fitting that in this exceptional – and exceptionally difficult – year, a single word came immediately to the fore,” the dictionary publisher said.

In the absence of a federal blueprint to curb the spread of the virus, states are issuing new or revamped restrictions on businesses and social life.

California’s governor said he may renew a stay-at-home order in the coming days, warning that ICU admissions are on track to exceed statewide capacity by mid-December unless public health policies and social behavior change.

“The red flags are flying,” Governor Gavin Newsom told reporters in an online briefing. “If these trends continue, we’re going to have to take much more dramatic, arguably drastic, action.”

(Reporting by Reuters staff; Writing by Daniel Trotta; Editing by Bernadette Baum)

U.S. hits highest death toll since May with hospitals already full

By Daniel Trotta

(Reuters) -Daily U.S. deaths from COVID-19 surpassed 2,000 for the first time since May and with hospitals across the country already full, portending a surge in mortalities to come as the coronavirus pandemic casts a shadow over the holiday season.

The death toll reached 2,157 on Tuesday – one person every 40 seconds – with another 170,000 people infected, numbers that experts say could grow with millions of Americans disregarding official warnings and traveling for Thursday’s Thanksgiving holiday.

The deadliest day in more than six months was still short of the record of 2,806 deaths on April 14, in the early stages of the pandemic, according to a Reuters tally of official data. That one-day figure is sometimes reported higher due to a backlog of deaths that were not compiled until April 14.

With U.S. hospitalizations for COVID-19 reaching a record high of 87,000 on Tuesday, the nation’s leading infectious diseases official urged people to keep Thanksgiving gatherings as small as possible.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, stressed the need to “hang in there a bit longer” on wearing masks, maintaining distance and avoiding crowds, especially indoors.

“If we do those things, we’re going to get through it. So that’s my final plea before the holiday,” Fauci told the ABC News program “Good Morning America” on Wednesday.

Families with university students have been forced to evaluate the risk of reuniting for Thanksgiving.

Francesca Wimer, a student at Northwestern University in Illinois, flew home to Washington wearing an N95 mask and a face shield and checked into a hotel for 14 days, quarantining to protect her parents and grandparents.

“She was returning to a vulnerable set of people. We didn’t trust that a test was enough,” said her mother, Cynthia Wimer.

Others are just staying put.

Luke Burke, studying at Syracuse University in upstate New York, was planning to spend Thanksgiving with his family in New Jersey until his roommate tested positive last week.

“I’m sorry I can’t be there with my parents, but it’s the right thing to do,” Burke said.

Meanwhile school districts across the United States face pressure from all sides as they grapple with how to educate children during the pandemic, a Reuters survey of 217 districts showed.

Many parents are balking at online instruction, while others worry about sending kids back into classrooms prematurely. Teachers say they are not comfortable teaching in person.

“Every school district across the nation is in the position in which no matter what decision they make and how well thought out it is, it will leave some in the community thinking it’s the wrong decision,” said Larry Rother, senior executive director of pre-kindergarten through 12th-grade educational services in Chandler, Arizona.

Help may be coming with vaccines showing promise.

Officials from the U.S. government’s Operation Warp Speed program told reporters on Tuesday they plan to release 6.4 million COVID-19 vaccine doses nationwide in an initial distribution after the first one is cleared by regulators for emergency use, which could happen as soon as Dec. 10.

If all goes well, 40 million doses will be distributed by the end of the year, they said.

A Food and Drug Administration ruling on emergency use for Pfizer Inc’s vaccine is expected on Dec. 10.

(Reporting by Daniel Trotta, Lisa Shumaker, Gabriella Borter, Lisa Lambert, Kristina Cooke, Benjamin Lesser, M.B. Pell and Simon Lewis; Editing by Chizu Nomiyama, Andrea Ricci and Jonathan Oatis)

Despite COVID-19 travel warnings, many Americans ‘not living in fear’ ahead of Thanksgiving

By Daniel Trotta and Nathan Layne

(Reuters) – Millions of Americans appear to be defying health warnings and traveling ahead of the Thanksgiving holiday, likely exacerbating a surge in coronavirus infections before a series of promising new vaccines become widely available.

With U.S. COVID-19 infections hitting a record 168,000 per day on average, Americans are flocking to airports against the advice of the Centers for Disease Control and Prevention (CDC), the U.S. surgeon general and Dr. Anthony Fauci, the nation’s top infectious disease expert.

For Americans, the long holiday weekend, which begins on Thursday, is traditionally the busiest travel period of the year, and 2020 may prove to be no exception.

Some 1 million passengers passed through airport screenings on Sunday, the highest number since March. It was the second time in three days that passengers screened topped 1 million but screenings are down nearly 60% from the same time last year, the U.S. Transportation Security Administration said.

Meanwhile, the seven-day average number of U.S. COVID-19 deaths rose for a 12th straight day, reaching 1,500 as of Monday, according to a Reuters tally of official data.

That has further taxed already exhausted medical professionals, as coronavirus hospitalizations have surged nearly 50% over the past two weeks and the United States has surpassed 255,000 deaths and 12 million infections since the pandemic began.

Pleading with residents to stay home and avoid gatherings during the holiday season, Governor Andrew Cuomo reminded New Yorkers of the grim early days of the pandemic when as many as 800 people died in a single day in the state.

Hospitalizations have spiked 122% in New York state over the last three weeks, Cuomo said, prompting the re-opening of an emergency medical facility on Staten Island.

Help could arrive soon. The head of the U.S. campaign to rapidly deploy a vaccine said the first Americans could start receiving vaccinations as early as mid-December, and another global drug company on Monday unveiled promising trial results on a vaccine candidate.

“NOT LIVING IN FEAR”

Still, many Americans are refusing to follow the health advice that could save their lives.

In Pennsylvania, the number of COVID-19 tests coming back positive was 25% last week, according to data from The COVID Tracking Project. On Monday, Secretary of Health Dr. Rachel Levine warned that the latest models indicated the state could start to run out of intensive care unit beds within a week.

Linda Lafferty, a nurse and the owner of a bed and breakfast in McConnellsburg, said family and friends gathered on the first Sunday in November to celebrate, as they do every year because she and others often have to work on Thanksgiving Day.

But Lafferty said her family would have assembled if they could.

“We are not living in fear and if we were able to get together on Thanksgiving Day we absolutely would,” said Lafferty, 47. “We would still get together and we wouldn’t limit the number of folks because if you are family you are family.”

To be sure, many Americans said they would do their best to conform with health recommendations.

Donnalie Hope, a 78-year-old resident of Petersburg, West Virginia, is planning to make fresh cranberries, mash potatoes and her famous corn pudding for Thanksgiving, which she will spend with her daughter, who will be visiting, and a neighbor.

Hope said they would social distance as much as possible in her home, and that she planned to ready rubber gloves and hand sanitizer. She acknowledged that her guests might eventually take off their masks in the home.

“I’m trying very hard to comply with the regs because I want this country to get back to where it belongs,” she said.

(Reporting by Daniel Trotta and Nathan Layne; Additional reporting by Lisa Lambert, David Shepardson and Susan Heavey in Washington, Barbara Goldberg in Maplewood, New Jersey; Writing by Daniel Trotta and Maria Caspani; Editing by Bernadette Baum and Lisa Shumaker)

U.S. prepares for first COVID-19 shots as another vaccine candidate emerges

By Daniel Trotta

(Reuters) – U.S. officials expect to begin inoculating Americans against the novel coronavirus by mid-December as another global drug company on Monday unveiled promising trial results on a vaccine candidate, providing hope as the pace of infections accelerated.

The head of the U.S. campaign to rapidly deploy a vaccine that U.S. healthcare workers and other high-risk people could start getting shots produced by Pfizer Inc within a day or two of regulatory consent next month.

“I would expect, maybe on day two after approval on the 11th or 12th of December, hopefully the first people will be immunized across the United States,” Dr. Moncef Slaoui, chief scientific adviser for “Operation Warp Speed,” told CNN on Sunday.

With many Americans traveling and potentially increasing their risk ahead of the Thanksgiving holiday on Thursday, the United States has surpassed 12 million infections and the death toll has climbed to more than 255,000 since the pandemic began.

Coronavirus hospitalizations have surged nearly 50% over the past two weeks as the pace of new infections quickened, and the average number of new COVID-19 deaths reported in United States has been increasing for 12 days.

The latest vaccine breakthrough came on Monday as British company AstraZeneca said its vaccine could be 90% effective without any serious side effects. The vaccine would give the world another important tool against the pandemic and one that is potentially cheaper to make, easier to distribute and faster to scale up than those of rivals.

The vaccine was 90% effective in preventing COVID-19 when administered in two different doses a month apart, late-stage trials showed.

The British drugmaker said it would have as many as 200 million doses by the end of 2020 and 700 million doses could be ready globally as soon as the end of the first quarter of 2021.

Pfizer, working with German partner BioNTech, says its vaccine was 95% effective against infection from the highly contagious respiratory virus.

Other pharmaceutical companies making progress include Moderna Inc, which is expected to seek separate approval later in December, and Johnson & Johnson, which is working on a single-dose vaccine.

In the United States, the first people to receive the Pfizer vaccine would likely include doctors, nurses and front-line emergency medical personnel, as well as those at the highest risk of severe illness and death from the virus, Slaoui said.

But U.S. Surgeon General Jerome Adams expressed concern that Americans who are dismissive of science and skeptical about vaccines may discourage people from getting their jabs.

“What I’d hate is for us to have a vaccine that could end this pandemic but people don’t trust it,” Adams told the ABC News show “Good Morning America” on Monday.

“I’m just excited we now have three vaccines out there because when you’re trying to immunize the entire planet we want to have as many different tools in our arsenal as possible,” Adams said.

Adams warned Americans that holiday parties “can be super-spreader events,” while New Jersey Governor Phil Murphy urged people to scale back or cancel Thanksgiving plans.

“We’ve pleading with people: Please, God, do the right thing,” Murphy told “Good Morning America.”

California Governor Gavin Newsom said late Sunday he would quarantine for 14 days after three of his children were exposed to a California Highway Patrol officer who tested positive for the virus.

(Additionl reporting by Lisa Lambert, Susan Heavey, Doina Chiacu, Kate Holton, Josephine Mason and Kate Kelland; Editing by Bernadette Baum)

Moderna would seek limited emergency use of COVID-19 vaccine based on early data

By Julie Steenhuysen

CHICAGO (Reuters) – If Moderna Inc’s COVID-19 vaccine proves to be at least 70 percent effective, the company plans to seek emergency authorization for its use in high-risk groups, the company’s chief executive told Reuters.

Moderna’s vaccine candidate – mRNA-1273 – is nearing the finish line in its push to enroll 30,000 individuals in a late-stage trial of a novel coronavirus vaccine. But the company may be able to declare victory early if it is able to show that people who got the vaccine fared much better in its trial that people who didn’t.

Vaccines must demonstrate they are at least 50% more effective than a placebo to be considered for approval. To prove that, government officials have said, at least 150 COVID-19 infections must be recorded among trial participants with at least twice as many occurring among the placebo group.

If a vaccine is especially effective, companies could have their answer sooner.

An independent safety board will take a first look at Moderna’s data as soon as a total of 53 people in the trial become infected with COVID-19. Moderna is projecting the interim analysis will occur in November, but it could come as early as October.

If most of the people who got sick got the placebo shot, that would indicate the vaccine was protecting those inoculated and could be enough evidence to seek U.S. regulatory approval for Emergency Use Authorization (EUA).

“If the interim readout is deemed by the independent safety committee as positive with 70 or 80 or 90% efficacy, we will indeed consider approval,” Stephane Bancel, Moderna’s chief executive officer, said in a telephone interview.

“At such a level of efficacy, if we get there, we can protect a lot of lives in the people at the highest risk, and so, we will consider filing for an EUA for a very limited population,” Bancel said.

He said the FDA will determine whether the benefit of the vaccine to a small group of high-risk individuals outweighs the risk of not having a full readout of safety data from all 30,000 study participants.

The two groups of high-risk individuals who might be covered in such an EUA would be healthcare workers and the elderly, Bancel said.

Bancel said the company wants to gather more data on the safety of the vaccine in the study population over a period of several months before seeking full FDA approval.

Moderna released its study protocol on Thursday, making public details on how its vaccine will be evaluated. If the vaccine does not reach the efficacy mark after 53 cases, the data safety and monitoring board will take another interim look at the data after 106 cases, and a final look after 151 people in the trial become infected with the virus.

Public health officials have said that approving a vaccine for widespread use based on a small number of cases would not offer enough safety information to show how the vaccine would perform.

Moderna, which has never brought a vaccine to market, has received nearly $1 billion from the U.S. government under its Operation Warp Speed program. It has also struck a $1.5 billion supply agreement with the United States.

In a presentation to investors on Tuesday, Pfizer Inc said the company has enrolled more than 29,000 people in its 44,000-volunteer trial to test an experimental COVID-19 vaccine the company is developing with German partner BioNTech.

Pfizer expects to have enough data to show whether the vaccine works by the end of October.

(Reporting by Julie Steenhuysen; editing by Peter Henderson and Cynthia Osterman)

U.S. inks $1.5 billion deal with Moderna for 100 million doses of COVID-19 vaccine

By Jeff Mason and Carl O’Donnell

(Reuters) – The United States has entered an agreement with drugmaker Moderna Inc to acquire 100 million doses of its potential COVID-19 vaccine for around $1.5 billion, the company and White House said on Tuesday.

The United States in recent weeks has made deals to acquire hundreds of millions of doses of potential COVID-19 vaccines from several companies as part of its Operation Warp Speed program, which aims to deliver a vaccine in the country by the end of the year.

Moderna’s price per dose comes to around $30.50 per person for a two dose regimen.

With the exception of its deal with AstraZeneca, which offered a lower price per drug in exchange for upfront research and development costs, all the deals price COVID-19 vaccines between $20 to $42 for a two dose course of treatment.

Moderna’s vaccine candidate, mRNA-1273, is one of the few that have already advanced to the final stage of testing and is on track to be completed in September, the company said this month.

Moderna’s deal with the U.S. only pays out in full if the drugmaker hits certain unspecific timing benchmarks for vaccine delivery.

The United States has advanced purchase agreements with Johnson & Johnson, AstraZeneca Plc, Pfizer Inc and BioNTech SE, and Sanofi SA and GlaxoSmithKline Plc for their respective vaccine candidates.

The agreements would lock in more than 500 million doses of COVID-19 vaccine for the U.S., assuming that the companies involved receive regulatory approval. Some deals also give the United States an option to purchase additional doses.

The U.S. government previously gave Moderna around $1 billion to fund its research efforts, bringing total U.S. funding to around $2.5 billion.

Other countries, including Japan, the United Kingdom and Canada, have forged similar deals with drugmakers.

(Reporting by Jeff Mason and Carl O’Donnell; Editing by Peter Henderson, Chris Reese and Tom Brown)

Moderna’s COVID-19 vaccine candidate moves into late-stage trial

By Manojna Maddipatla

(Reuters) – Moderna Inc. said on Monday it had started a late-stage trial to test the effectiveness of its COVID-19 vaccine candidate, the first such study under the Trump administration’s program to speed development of measures against the novel coronavirus.

News of the study, which will test the response to the vaccine in 30,000 adults who do not have the respiratory illness, pushed shares in Cambridge, Massachusetts-based Moderna up more than 8% before the bell.

The federal government is supporting Moderna’s vaccine project with its Operation Warp Speed program. Moderna has received nearly $1 billion from the U.S. government, which has chosen it as one of the first to enter large-scale human trials.

More than 150 coronavirus vaccine candidates are in various stages of development, with 23 prospects in human trials across the globe and Moderna’s candidate among the farthest along in development.

“Having a safe and effective vaccine distributed by the end of 2020 is a stretch goal, but it’s the right goal for the American people,” National Institutes of Health Director Francis Collins said in a release from the NIH announcing the start of the study.

The large late-stage trial is designed to evaluate the safety of Moderna’s mRNA-1273 and determine if the vaccine can prevent symptomatic COVID-19 after two doses.

The study also seeks to answer if the vaccine can prevent death caused by COVID-19 and if just one dose can prevent symptomatic COVID-19.

Trial volunteers will receive two injections about 28 days apart, with volunteers randomly assigned to receive either two 100 micro gram injections of mRNA-1273 or two shots of a saline placebo. The study is blinded, so the investigators and the participants will not know who is assigned to which group.

Results of a small early-stage study published earlier this month showed volunteers who got two doses of Moderna’s vaccine had high levels of virus-killing antibodies that exceeded the average levels seen in people who had recovered from COVID-19.

Moderna said it remains on track to deliver about 500 million doses a year, and possibly up to 1 billion doses a year, beginning 2021.

Brokerage BMO Capital Markets said a U.S. supply deal with Moderna for its vaccine candidate is inevitable, adding that there likely will be deals with other governments as well.

(Reporting by Manojna Maddipatla and Ankur Banerjee in Bengaluru; Editing by Shinjini Ganguli, Lewis Krauskopf and Steve Orlofsky)

U.S. to pay Pfizer, BioNTech $1.95 bln for millions of COVID-19 vaccine doses

By Ankur Banerjee and Michael Erman

(Reuters) – The U.S. government will pay $1.95 billion to buy 100 million doses of Pfizer Inc and German biotech firm BioNTech SE’s COVID-19 vaccine candidate if they are able to successfully develop one, the companies said on Wednesday.

Pfizer said they will not receive any money from the government unless the vaccine is deemed to be safe and effective and is successfully manufactured.

The agreement allows the U.S. government to acquire an additional 500 million doses, the Department of Health and Human Services (HHS) and the Department of Defense said.

HHS said the vaccine will be made available to Americans at no cost, although their health insurance may be charged.

In clinical trials, Pfizer and BioNTech have been testing vaccines that require two injections. That means a supply of 100 million doses would likely vaccinate 50 million Americans.

The Trump administration has agreed to spend billions of dollars for the development and procurement of potential vaccines. The administration launched Operation Warp Speed — a joint HHS and Department of Defense program — to accelerate the development of coronavirus vaccines, treatments and diagnostics.

More than 150 coronavirus vaccines using a variety of technologies are in development globally, with some two dozen already in human trials. Governments have signed deals with drugmakers to secure the supply of various vaccine candidates.

Pfizer and BioNTech’s vaccine candidate is among those that are set to be tested in a large trial. The vaccine has shown promise in early-stage small studies in humans.

Pfizer will deliver the doses if the product receives emergency use authorization or licensing from the U.S. Food and Drug Administration, after demonstrating safety and efficacy in a large Phase 3 clinical trial.

The companies said they expect to be ready to seek some form of regulatory approval as early as October if the ongoing studies are successful.

Pfizer and BioNTech currently expect to manufacture up to 100 million doses globally by the end of 2020, and potentially more than 1.3 billion doses by the end of 2021, subject to final dose selection from their clinical trial.

(Reporting by Ankur Banerjee in Bengaluru; Editing by Shounak Dasgupta)

Fauci bullish on prospects for U.S. vaccine, not worried about China winning race

By Julie Steenhuysen

(Reuters) – The leading U.S. expert on infectious diseases, Dr. Anthony Fauci, predicted on Wednesday the country will meet its goal of a coronavirus vaccine by year’s end and was unmoved by the prospect that China would get there first.

While there are no guarantees, “I feel good about the projected timetable,” Fauci told Reuters in an interview.

His comments follow promising early stage data for the Moderna Inc’s coronavirus vaccine, released on Tuesday, that was developed with scientists at the National Institute of Allergy and Infectious Diseases, which Fauci directs.

Many experts see a safe and effective vaccine as the only way out of the pandemic that has infected millions and killed more than 575,000 people worldwide.

Fauci said Moderna’s results were especially promising because the vaccine appeared to offer the type of protection seen in a natural infection.

In vaccine development, “one of the things that you hope for is that your vaccine induces a response that’s comparable to a natural infection, because theoretically, the best vaccine you could possibly ever get is a natural infection.”

Moderna’s candidate, which is set to enter the last stage of testing on July 27, is just one of more than a hundred vaccines in development globally, but only one of a few contenders that have earned millions of dollars in backing from Operation Warp Speed, the White House program that aims to deliver more than 300 million doses of a safe and effective COVID-19 vaccine by January.

Fauci, who has become a popular and trusted figure during the coronavirus outbreak, came under criticism from President Donald Trump and some of his Republican allies as Fauci cautioned against reopening the U.S. economy too soon.

Asked how he copes with the attacks on his character and allegiance to the president, Fauci told Reuters, “I don’t let it bother me. What we’re doing with vaccines, what we’re doing with therapeutics, what we’re doing with clinical trials is the real substance,” Fauci said.

VACCINE RACE

As U.S. states have begun to reopen businesses and coronavirus infections have soared, some White House officials have pointed fingers at China, where the virus first emerged late last year.

Fauci was unmoved by the prospect that China could cross the finish line first. Although he said he hopes China succeeds, he does not think they will win the vaccine race, at least not by much.

“I think everybody’s sort of on the same track.” If they do get there, he said, “They’re not going to get it particularly sooner than we get it. That’s for sure.”

Ultimately, he hopes multiple successful candidates prevail. “I don’t worry about anybody getting there first.”

Even if a vaccine succeeds in provoking an immune response, Fauci said it is still not clear how long that protection will last.

“These are questions that don’t have answers right now, because we’re only six months into the outbreak.” He said it may take a year before that immunity question is answered.

A recent Reuters poll found that a quarter of Americans are hesitant about taking a vaccine, voicing concern that the record pace of development could compromise safety. Fauci said he is aware of such concerns.

“It’s understandable, but unjustified,” he said. “We’re not compromising safety; we’re not compromising scientific integrity.”

Fauci said the normal development process of waiting for a vaccine to be proven effective before manufacturing begins wastes precious time.

“If the vaccine doesn’t work, the only thing you’ve lost is money.”

(Reporting by Julie Steenhuysen in Chicago; Editing by Lisa Shumaker)