Governments and drugmakers are weighing how to roll out coronavirus vaccines, including reserving the first batches for health-care workers, as several shots race to early leads.
Of more than 100 vaccines in development globally, at least eight have started testing in humans, including candidates from Moderna Inc. and Pfizer Inc. At the same time, pharmaceutical giants like Johnson & Johnson, AstraZeneca PLC and Sanofi SA are building capacity to make hundreds of millions of doses of their own or their partners’ vaccines.
The efforts are part of a larger rush, including at the White House, to line up funding for accelerated testing and expanded manufacturing capacity, all to make doses available in the U.S. starting as soon as this fall.
A safe and effective vaccine is the best way to prevent Covid-19, the respiratory disease caused by the new coronavirus, and to curb its transmission, public-health officials say. Drugmakers say they are developing potential coronavirus vaccines at remarkably fast speeds.
Yet there isn’t a guarantee that any of the most advanced vaccine candidates will prove to work safely on such a short timetable. Some, like vaccines from Pfizer and Moderna, are based on relatively new technologies that haven’t been approved previously.
Once a vaccine is proved in clinical testing to work safely, drugmakers expect the U.S. Food and Drug Administration would move quickly to permit its use, even if the agency doesn’t have all the evidence it typically collects before granting an approval.
The FDA authorized such an emergency use of the drug remdesivir from Gilead Sciences Inc., for treating hospitalized Covid-19 patients on May 1, days after a study showed it shortened hospital stays.
The agency, which regulates drugs and vaccines, “will make use of all appropriate regulatory authorities and provide rapid advice to expedite the development and availability of a safe and effective Covid-19 vaccine,” an FDA spokesman said.
Several drugmakers that have been building up their capabilities to make coronavirus vaccines, have pledged to deliver millions of doses this year. Yet a fuller supply to vaccinate the general population might not become available until well into 2021, according to company projections and estimates by vaccine experts.
Public-health officials and vaccine experts hope more than one vaccine will cross the finish line, to boost the total number of doses available.
“Ideally we’d want seven or eight billion doses the day after licensure, so we can vaccinate the whole world,” said Walter Orenstein, associate director of Emory University’s vaccine center in Atlanta. “The likelihood is we won’t have enough to vaccinate even the entire U.S. population” when a vaccine first becomes available, he said.
Makeshift sheets displaying a message of protest hang in the window of an apartment building in Columbia Heights in Washington, D.C., on May 18.
President Donald Trump speaks with restaurant executives and industry leaders during a coronavirus pandemic meeting in the White House in Washington, D.C., on May 18.
Barricade tape cordons off seating as precautionary measures are taken to maintain a safe distance for concertgoers prior to Travis McCready's performance at TempleLive on May 18, in Fort Smith, Arkansas.
Angie O'Neill works on the hair of Phil Quinn at the Las Olas Barber shop on May 18, in Fort Lauderdale, Florida. The barbershop re-opened, approximately two months after shutting it's doors due to the coronavirus pandemic.
Zookeeper Kim Richards answers questions and displays Monty the ball python to guests at the Cruise the Zoo drive-thru program at the Phoenix Zoo after coronavirus disease prevention restrictions were lifted in Phoenix, Arizona, on May 18.
A sanitation crew works on May 18, 2020, in Point Lookout, New York. Waste disposal workers have been classified as essential during the coronavirus pandemic.
A sign reading "Sanitized, ready to be seated" is seen on a table in a restaurant terrace as Miami reopens shops, restaurants, cafes and beauty salons after measures against the novel coronavirus began to be lifted in Miami, Florida, on May 18.
A wooden sign on a resident's roadside lawn celebrates front-line caregivers on May 17, in Charlotte, Vermont.
An inspirational message is seen on the marquee of the Cobble Hill Cinemas on May 17, in New York.
George Washington University graduate Catalina Perez, right, receives a paper copy of her diploma from neighbor Paula Lytle as they keep a social distance at a surprise graduation party. Perez completed her undergraduate studies in International Affairs across the span of ten years only to miss her commencement due to the coronavirus disease outbreak in Washington, on May 17.
New York Police Department School Safety officer Bynoe, right, hands out face masks to women at Brooklyn Bridge Park during the coronavirus pandemic, on May 17.
House Majority Leader Ryan Winkler, DFL-Golden Valley, walked into the House Chamber wearing a mask on May 17. All the DFL legislators chose to wear masks on the House floor and all the Republican legislators chose not to. The House floor on the final day of the regular Minnesota legislative session that votes may be cast for bills. A small number of legislators including their leaders, must stay in St Paul. The rest listen or watch from their homes or offices. All votes are cast by roll call vote, recorded by the Chief Clerk Patrick Duffy Murphy.
A member of the Metro Praise International church preaches outside while services are held inside, defying stay-at-home orders in Chicago, Illinois, on May 17.
A woman and children wear face coverings as a precaution against the coronavirus while crossing a bridge in Barr Lake State Park on May 17 near Brighton, Colorado.
After being closed for several weeks due to the coronavirus outbreak, Chandler Fashion Center Mall welcomes back patrons on May 17 in Chandler, Arizona. While the mall was open, many of the chain stores remained closed.
Light displays are seen as part of an event organized by the Coalition on Race to show solidarity in recognition of the impact of the coronavirus disease on the community in Maplewood, New Jersey, on May 17.
Workers remove signage of the Gem Spa, an iconic East Village corner store open since the 1920s. The owner says it had to close its shopfront due to falling revenue which was affected in part by recent shutdowns, in Manhattan, New York City, on May 17.
Annalise D'Andrade, her wife Kara Danner and daughter McKayla watch Pastor Sarah Scherschligt as they attend mass online from their living room on May 17, in Great Falls, Virginia.
An attendee has his temperature checked by NASCAR Security prior to the NASCAR Cup Series The Real Heroes 400 at Darlington Raceway on May 17, in South Carolina. NASCAR resumes the season after the nationwide lockdown due to the ongoing Coronavirus (COVID-19).
In an aerial view from a drone, tennis players at Sweet Hollow Park observe New York State rules including 'singles' games only on May 17, in Melville, New York. New York opened tennis courts this weekend with health guided stipulations in light of the ongoing coronavirus pandemic.
Shoppers wearing masks are seen at Eastern Market in Washington on May 17. Washington's mayor extended the lockdown till June 8 amid a stream of new coronavirus cases.
Father Shaun Foggo (C) performs the exposition of the Blessed Sacrament for his parishioners, who remain in their cars due to the coronavirus COVID-19 pandemic, in the parking lot of Our Lady of Sorrows Catholic Church in Takoma Park, Maryland on May 17.
Ignoring social distancing protocol and regulations, people have taken to tearing down the caution tape that once cordoned-off public swings along the Ohio River at Smale Waterfront Park in the wake of the Coronavirus COVID-19 pandemic, on May 16, in Cincinnati, Ohio.
Torrey Pines High School graduating student Phoebe Seip (18, center), and her sisters Sydney (22, left) and Paisley, 6, watch former U.S. President Barack Obama deliver a virtual commencement address to millions of high school seniors who will miss graduation ceremonies due to the coronavirus disease outbreak, while celebrating Phoebe's canceled prom night at home in San Diego, California, on May 16.
People try to keep social distance as they enjoy a warm afternoon at Domino Park in Brooklyn, New York, on May 16.
Reopen Illinois protesters rally outside Thompson Center in downtown Chicago, on May 16 during the coronavirus pandemic.
A patron speaks to a bartender wearing a facemask at Turtle Bay, a bar in the French Quarter, on the first day of New Orleans' reopening Phase 1, after two months of closures due to the novel coronavirus pandemic, in Louisiana on May 16.
People traverse the Seaside Heights boardwalk as the state begins to reopen beaches and boardwalks amid the novel coronavirus pandemic on May 16. New Jersey Gov. Phil Murphy said he is willing and ready to bring back social distancing rules if he begins to see a spike in cases in the sates. "If we have to pull the brakes we will do that."
New York City Mayor Bill De Blasio gives a thumbs up next to children as he gives away face masks to people for using on public spaces to prevent the spread of coronavirus disease (COVID-19) in the Queens borough of New York City, on May 16.
Decommissioned and suspended commercial aircrafts are seen stored in Pinal Airpark on May 16, in Marana, Arizona. Pinal Airpark is the largest commercial aircraft storage facility in the world, currently holding increased numbers of aircraft in response to the coronavirus COVID-19 pandemic.
Volunteers from the Police and Fire departments give out care kits containing masks, sanitizing supplies, personal care items and education materials at Lynn Technical High School in Lynn, Massachusetts on May 16.
Caution tape is pulled across the entrance of independent music venue Snug Harbor on May 16 in Charlotte, North Carolina. Music venues around the country have been shut down since the coronavirus pandemic gripped much of the United States in early March.
Customers wearing protective masks and keeping social distancing space, line up to enter a Costco Wholesale store in the Van Nuys section of Los Angeles, on May 16.
WondaLunch volunteer delivers free packed lunches to Atlanta residents during WondaLunch On Us hosted by Janelle Monae and the Wondaland Arts Society at the Gathering Spot on May 16 in Atlanta, Georgia.
A jogger passes construction work next to the Eisenhower Executive Office Building in Washington, DC, on May 16 during the coronavirus pandemic. DC Mayor Muriel Bowser has extended the city's stay-at-home order until June 8.
First daughter and adviser to President Donald Trump, tours the distribution center of Coastal Sunbelt Produce on May 15 in Laurel, Maryland. Ivanka Trump and U.S. Agriculture Secretary Sonny Perdue placed a visit to Coastal Sunbelt Produce, a participant of the new $3 Billion Purchase and Distribution Program, also known as Farmers to Families Food Box Program. It is a part of USDA’S Coronavirus Farmer Assistance Program using funding and authorities provided in the CARES Act and the Families First Coronavirus Response Act (FFCRA) to source food from small business farms and distribute to non-profits and faith-based groups.
A graduate from California State University San Marcos celebrates while participating in a car parade through campus during the outbreak of the coronavirus disease in San Marcos, California, on May 15.
Guests smile as they ride a water slide at Golfland Sunsplash water park after the coronavirus disease restrictions were eased in Mesa, Arizona, on May 15.
Dr. Charles Collins gets his hair cut by barber Lannie Hale at the Waveland Barber Stylist shop, on May 15 in Des Moines, Iowa. It was the first day Hale was allowed to reopen his shop after being closed for nearly two months due to the coronavirus pandemic.
President Donald Trump speaks on vaccine development in the White House in Washington, D.C on May 15.
A demonstrator holds a placard with a face mask stating "THE NEW SYMBOL OF TYRANNY MUZZLE" rallying outside the Pennsylvania Capitol Building to protest the continued closure of businesses due to the coronavirus pandemic on May 15 in Harrisburg, Pennsylvania.
Volunteers organize bags with food during a food distribution at St. Bartholomew's Roman Catholic Church on May 15in New York.
A man pushes a trolley of Trump merchandise as demonstrators rally outside the Pennsylvania Capitol Building to protest the continued closure of businesses due to the coronavirus pandemic on May 15 in Harrisburg, Pennsylvania.
Truckers protest low rates and lack of broker transparency during the coronavirus pandemic on May 15 in Washington, D.C
A sign of thanks sits outside Plainview Hospital, part of Northwell Health, to honor health care and front-line workers battling COVID-19 on May 15 in Plainview, New York.
An Air Force C-17 Globemaster III of the 452nd Air Mobility Wing from March ARB completes a flyover of the Loma Linda University Medical Center to the excitement of the hospital staff on the ground in a salute to the frontline workers who are battling the coronavirus pandemic on May 14, in Murrieta, California.
Justin and Joanne Waters kiss after they were married in a walk up and drive-thru wedding ceremony at the Family and Civil courthouse in Gainesville, Florida, on May 14.
Jerry A. Mann, second from right, stands with his grandmother, Sylvia Rubio, as he prepares to be tested for COVID-19 by the San Antonio Fire Department at a free walk-up test site set up to help underserved and minority communities in San Antonio, Texas, on May 14.
Illusionist Criss Angel, center, counts boxes of food and other items as they are organized outside the Cure 4 The Kids Foundation pediatric cancer treatment center amid the spread of the coronavirus on May 14, in Las Vegas, Nevada.
Friends Carrie Nasi left, Tracey, Cindy Colema and Lori Stayberg, met for food and drinks at Jonesy's Local Bar on the first day of the bar reopening in Hudson. Bars, restaurants and everything else is reopening in Wisconsin after the state Supreme Court struck down the state's stay-at-home order on May 14.
Food Bank for the Heartland volunteers hold up bags of fruit as they direct arriving cars at a drive-thru location in Omaha, Nebraska, on May 14. The number of Nebraskans filing new unemployment claims appears to be stabilizing but is still far higher than it was before the coronavirus pandemic, according to data released Thursday.
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The prospect of limited initial supplies has triggered maneuvering over which countries get first dibs. Companies receiving U.S. federal grants, including J&J, Moderna and Sanofi, are expected to reserve some doses for Americans, according to industry officials.
The nonprofit Coalition for Epidemic Preparedness Innovations, which promotes the equitable allocation of vaccines around the globe, recently agreed to give more than $380 million to Novavax Inc., of Gaithersburg, Md., to help develop a vaccine that would be made in various countries for distribution world-wide.
In the U.S., a government agency such as the Centers for Disease Control and Prevention would probably decide where newly authorized vaccines should be delivered and which groups should get immunized first, public-health experts say.
State health officials are discussing whether to mobilize for coronavirus immunizations an existing network of state agencies that run childhood vaccination programs at public clinics and via private health-care providers under the CDC’s supervision, said Claire Hannan, executive director of the Association of Immunization Managers, which represents state immunization officials.
Groups likely to be at the head of the line for access are front-line health-care workers and first responders, plus essential workers like grocery, pharmacy, food-supply and mass-transit employees, said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, who serves on a committee with federal and drug-industry officials that is trying to accelerate coronavirus vaccine development.
Johnson & Johnson expects to have some batches of its vaccine ready by early 2021, which Chief Scientific Officer Paul Stoffels said should be sufficient to vaccinate health-care workers globally. The company expects to eventually make more than a billion doses.
Moderna is expanding its vaccine production capacity, including via a partnership with Swiss contract manufacturer Lonza Ltd., to make tens of millions of doses a month by the end of this year, and eventually as many as one billion doses a year, said Chief Executive Stephane Bancel.
Drugmakers probably won’t seek to tweak or improve vaccines that enter distribution because that would require another regulatory approval, said Florian Krammer, professor of vaccinology at the Icahn School of Medicine at Mount Sinai in New York.
Testing of early vaccines could show the way for subsequent shots, however, by giving researchers a better idea of the level of immune response needed to provide protection against the virus, Emory’s Dr. Orenstein said.
One open question is whether the elderly will benefit from a coronavirus vaccine. Immune systems decline with age, which can reduce vaccines’ effectiveness in older adults.
Some of the uncertainty lies in the design of some early coronavirus vaccine trials, which enrolled healthy volunteers from 18 to 55 or 60 years old to get a quick read on safety in people more likely to endure any side effects.
“Older adults tend to have less robust immune responses to vaccines, so we can’t necessarily extrapolate what happens in younger adults to what might happen in older adults,” said Dr. Lisa Jackson, a senior investigator at one of the study sites for the Moderna vaccine, the Kaiser Permanente Washington Research Institute.
The National Institute of Allergy and Infectious Diseases, however, recently expanded enrollment in a continuing trial of the vaccine it co-designed with Moderna to include adults older than 55.
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