Q&A: Where are we in the COVID-19 vaccine race?

By Carl O’Donnell

NEW YORK (Reuters) – Drugmakers and research centers around the world are working on COVID-19 vaccines, with large global trials of several of the candidates involving tens of thousands of participants well underway.

As some companies close in on unveiling their initial findings – with Canadian and European regulators already reviewing early data on some vaccines – the following is what we know about the race to deliver vaccines to help end the coronavirus pandemic that has claimed over a million lives:

Who is furthest along?

U.S. drugmaker Pfizer Inc with German partner BioNTech SE, U.S. biotech Moderna Inc and Britain-based AstraZeneca Plc in conjunction with University of Oxford researchers could provide early analyses of data from their various large trials as early as October or November. Johnson & Johnson is a bit further behind.

What happens in these trials?

The companies are testing their vaccines against a placebo – typically saline solution – in healthy volunteers to see if the rate of COVID-19 infection among those who got the vaccine is significantly lower than in those who received the dummy shot. Neither trial participants nor researchers know who has received the vaccine or placebo until the data is ready for review, or unblinded. The studies rely on subjects becoming naturally infected with COVID-19, so how long it takes to generate results largely depends on how pervasive the virus is where the trials are being conducted. In areas with large outbreaks and community spread, infections will pile up faster.

How will we know if the vaccine works?

The United States, the European Union, the United Kingdom and the World Health Organization have all set similar minimum standards for effectiveness. Vaccines must demonstrate at least 50% efficacy – meaning at least twice as many infections among volunteers who got a placebo as among those in the vaccine group. Independent panels oversee the trials to monitor for safety and effectiveness since the data is hidden from companies and researchers. These data safety monitoring boards take a peek at the interim results at pre-determined milestones, such as after a certain number of people have become infected. If the vaccine is looking significantly better than the placebo, the companies can apply for emergency use, and the study may be halted or continue to its intended conclusion. A trial can also be halted if the panel determines the vaccine to be unsafe.

Will regulators ensure a vaccine is safe before making it available to the public?

The U.S. Food and Drug Administration has said it will not approve a vaccine unless it is both effective and safe. Earlier this month, it added more stringent safety guidelines for U.S. vaccines. The FDA wants developers to follow trial subjects for at least two months after they receive their final vaccine dose to check for any side effects that may crop up. The agency will consider an emergency use authorization (EUA) once that data is collected from at least half of the trial’s participants. The UK Medicines and Healthcare products Regulatory Agency will review the vaccines for the UK and the European Medicines Agency will review vaccines for European Union use.

When will regulators decide?

Regulators will review the vaccines after the companies have enough data to submit applications seeking an EUA or formal approval. Moderna’s first look at data is more likely to come next month. AstraZeneca could provide a look at late-stage data in November. Pfizer/BioNtech said it may have data as early as October, but that it would wait for safety data it expects in the third week of November to file with U.S. regulators.

Regulators for Europe and Canada are considering data on a rolling basis, as it becomes available. The UK and the United States both expect speedy reviews of initial data for possible emergency use before more traditional lengthy reviews for formal commercial approvals.

Could these be the first approved coronavirus vaccines?

Yes, although China and Russia are on a similar timeline. China launched an emergency use program in July aimed at essential workers and others at high risk of infection that has vaccinated hundreds of thousands of people. At least four vaccines are far along including from China National Biotec Group [CHNAPF.UL] (CNBG), CanSino Biologics <6185.HK> and Sinovac. Sinovac and CNBG have said to expect early trial data as soon as November. Russia’s Gamaleya Institute has begun a 40,000-person late-stage trial and is expected to have early data at the end of October or early November. Russia has also given the vaccine to at least hundreds of “high-risk” members of the general population.

Is U.S. authorization up to President Trump?

The FDA must make sure that the benefits of a vaccine outweigh the risks before authorization since they are intended to be given to hundreds of millions of healthy people. However, the U.S. Department of Health and Human Services (HHS) has the authority to override the FDA’s recommendation. President Donald Trump has complained about the new safety guidelines, which delay any vaccine availability until after the Nov. 3 presidential election at the earliest. The Trump administration can hire and fire HHS officials, opening the possibility of political pressure to approve a vaccine.

(Reporting by Carl O’Donnell in New York; Additional reporting by Julie Steenhuysen in Chicago, Michael Erman in New York, Ludwig Burger in Frankfurt, Alistair Smout in London and Polina Ivanovo in Moscow; Editing by Caroline Humer, Bill Berkrot and Frances Kerry)

U.S. HHS announces further $20 billion funding to healthcare providers

(Reuters) – The U.S. Department of Health and Human Services on Thursday announced a fresh round of $20 billion funding for frontline healthcare providers dealing with the COVID-19 pandemic.

The new allocation will take into account financial losses and changes in operating expenses caused by the coronavirus, the agency said, adding that providers that have already received relief fund payments can also apply for more funds.

Providers who have recently begun practice and behavioral health providers grappling with a surge in mental health and substance abuse issues since the virus outbreak can also apply.

The move comes as prevalence of symptoms of anxiety and depressive disorders surged in the second quarter compared to a year ago, according to a recent Centers for Disease Control and Prevention report.

Since the start of the pandemic, the U.S. government has announced billions of dollars in support for hospitals and medical providers to meet the increased expenses from rising COVID-19 cases and to cover lost revenues due to suspension of medical procedures and routine visits.

The HHS has already issued over $100 billion in relief funding to providers through prior distributions.

(Reporting by Manojna Maddipatla in Bengaluru; Editing by Arun Koyyur)

Exclusive: U.S. hospitals turn down remdesivir supplies, limit use to sickest COVID-19 patients

By Deena Beasley

(Reuters) – U.S. hospitals have turned down about a third of their allocated supplies of the COVID-19 drug remdesivir since July as need for the costly antiviral wanes, according to unpublished government statistics provided to Reuters by a U.S. pharmacists’ group.

Some hospitals said they are still buying the Gilead Sciences medicine to build inventory in case the pandemic accelerates over the winter. But they said current supplies are adequate, in part because they are limiting use to severely ill patients.

The Food and Drug Administration has allowed more liberal remdesivir use, but 6 out of 8 major hospital systems contacted by Reuters said they were not using it for moderate cases.

The slowdown suggests that a shortage of the drug is over and threatens Gilead’s efforts to expand use of remdesivir, which it sells under the brand name Veklury in some countries.

The U.S. Department of Health and Human Services (HHS) told hospitals and other healthcare organizations on Friday that between July 6 and September 8, state and territory public health systems accepted about 72% of the remdesivir they were offered, Michael Ganio, senior director of pharmacy practice and quality at the American Society of Health-System Pharmacists, told Reuters.

Hospitals in turn took only about two-thirds of what states and territories accepted, he added. It was not immediately clear what happened to the surplus supplies.

Neither Gilead nor HHS immediately responded to requests for comment.

A surplus of remdesivir – which costs $3,120 for a 6-vial intravenous course – marks a turnaround from earlier in the pandemic, when supplies of the drug had fallen short of demand in some regions.

Government-led distribution of remdesivir will expire at the end of September. Hospitals said they have little information on availability after that.

Remdesivir was first authorized by the FDA in May for emergency use in COVID-19 patients hospitalized and on oxygen support after data showed that it helped shorten hospital recovery time.

The agency last month expanded use to hospitalized patients who do not require oxygen support, based on data published in the JAMA medical journal showing that the drug provided a modest benefit for those patients.

The newer data has left many experts unconvinced.

Dr. Aneesh Mehta, chief of infectious diseases services at Atlanta’s Emory University Hospital, said Emory is focusing supplies on patients likely to benefit the most.

“I am not terribly impressed with the study,” said Dr. Adarsh Bhimraj, an infectious disease specialist at the Cleveland Clinic. He said he remains “skeptical” about using remdesivir in patients with moderate COVID, especially given the price.

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

U.S. COVID-19 deaths exceed 180,000, cases continue to fall

By Lisa Shumaker

(Reuters) – U.S. deaths from the novel coronavirus topped 180,000 on Thursday after a surge of new cases in June and July, many of them in hotspots like California, Florida, and Texas.

There were some signs of an improving outlook. Last week, deaths fell 17% from the prior week and below an average of 1,000 a day for the first time in weeks, according to a Reuters analysis.

However, while U.S. metrics on cases, deaths, hospitalizations and test positivity rates were declining, health experts warned there could be another surge as schools reopen and colder weather forces more gatherings indoors.

This week, the U.S. Centers for Disease Control and Prevention (CDC) said people exposed to COVID-19 but not symptomatic may not need to be tested. This contradicted earlier guidance from the CDC, shocking doctors and politicians and prompting accusations that it may have been based not on sound science but on political pressure from the Trump administration.

The governors of New York, New Jersey and Connecticut slammed the CDC’s move as “reckless” and “not based on science,” and said they will not change testing guidelines in their states.

“CDC and HHS have not shared their scientific rationale for this change in policy, which substitutes sound science-based public health guidance with the president’s misinformation,” they said in a joint statement. “Health experts recommend testing close contacts of individuals with COVID-19 to identify and prevent asymptomatic spread. This type of robust testing by our states has been a key factor in our success so far to flatten the curve in the tri-state area.”

On Wednesday, the top U.S. government infectious disease expert Anthony Fauci told CNN he was having surgery during discussion of the change and expressed worry about the CDC’s move.

U.S. confirmed cases are now over 5.8 million – the highest total in the world. The U.S. death toll is also the world’s highest.

On a per capita basis, the United States ranks 12th in the world for the number of deaths, with 54 deaths per 100,000 people, and tenth in the world for cases, with 1,774 cases per 100,000 residents, according to a Reuters analysis.

U.S. consumer confidence dropped in August to its lowest in more than six years, as households worried about the labor market and incomes, casting doubts on the sustainability of the economy’s recovery from the COVID-19 recession.

The ebb in confidence followed the expiration of a $600 weekly unemployment benefit supplement on July 31.

For weeks, Republicans and Democrats have been deadlocked over the size and shape of a fifth coronavirus-response bill, on top of the approximately $3 trillion already enacted into law.

(Reporting by Lisa Shumaker, additional reporting by Maria Caspani, Editing by Rosalba O’Brien and David Gregorio)

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)

HHS to open ‘surge’ COVID-19 testing in Florida, Texas, Louisiana

(Reuters) – The U.S. government is creating short-term “surge” testing sites for the novel coronavirus in three metropolitan areas in Florida, Louisiana and Texas to meet demand from rising COVID-19 cases and hospitalizations, the U.S. Department of Health and Human Services (HHS) said on Tuesday.

The program adds testing for 5,000 people per day for a five- to 12-day period and will help identify new cases, particularly among asymptomatic people, and potentially limit the spread of the disease, Assistant Secretary for Health Admiral Brett Giroir said during a call with reporters.

The sites are opening on Tuesday in several locations in the Baton Rouge, Louisiana, area and on Wednesday at multiple sites in the Jacksonville, Florida, area and at one location in Edinburg, Texas.

Florida and Texas are among many U.S. states with high infection rates as a percentage of diagnostic tests conducted over the past week and long testing lines.

After assessing the impact of the testing on the rate of new cases in these areas, the government could deploy such surge testing sites in other locations around the country, Giroir said. He said no decisions have been made yet about other possible sites.

“We need to do this and see what the effect is,” he said.

The U.S. government has largely left testing for COVID-19 to the states after closing down most of the federal testing sites opened in March and April. The surge sites would supplement each state’s own testing plans.

HHS has tapped eTrueNorth, a U.S.-based company that has done community health center testing, for the sites. The tests are free and lab results are available in three to five days.

(Reporting by Caroline Humer in New York and Manojna Maddipatla in Bengaluru; Editing by Shounak Dasgupta and Jonathan Oatis)

Trump administration weighs emergency funds to combat coronavirus

By Jeff Mason and Susan Heavey

WASHINGTON (Reuters) – The Trump administration is considering asking lawmakers for emergency funding to ramp up its response to the fast-spreading coronavirus, a White House spokesman and an administration source said on Monday, though they did not say how much money was needed.

“We need some funding here to make sure that we … protect all Americans, that we keep us safe,” White House spokesman Hogan Gidley said on Fox News Channel.

Asked how much funding the administration may ask Congress to approve, Gidley later told reporters at the White House that there was no announcement yet on the amount.

Politico and the Washington Post, citing unnamed individuals familiar with the planning, had reported the administration may request $1 billion funding from the U.S. Congress. An administration official told Reuters the amount was still being finalized, and the request could go to lawmakers this week.

The official said U.S. Health and Human Services Secretary Alex Azar was seeking an amount that some within the administration viewed as out of proportion, given the limited number of U.S. cases and other HHS funding that has not yet been used.

The outbreak has spread beyond central China to South Korea, Iran and Italy, rattling global markets.

The United States has not seen the kind of community spread that has hit China, but health officials are preparing for such a possibility even as those Americans affected so far have been quarantined.

There have been 13 cases of people diagnosed with the virus in the United States and 21 cases among Americans repatriated on evacuation flights from the virus epicenter of Wuhan, China, as well as from a cruise ship in Japan, according to the U.S. Centers for Disease Control and Prevention.

Representatives for the U.S. Department of Health and Human Services declined to comment on the funding requests.

U.S. President Donald Trump has tapped Azar to lead a task force coordinating the response to the outbreak that the department has declared a public health emergency.

Democrats, who control the U.S. House of Representatives, have urged the administration to seek emergency funds after it notified Congress in recent weeks that it had already spent millions of dollars for its virus response, according to the Washington Post.

Trump has been at odds with his own White House advisers over China’s coronavirus response and has sought to downplay the impact of the virus, saying it could fade in April with warmer spring weather – something health experts said is unknown.

“We have aggressively worked to combat the spread of this virus, tried to prevent it as best we could from coming into this country,” Gidley told reporters.

The administration is also grappling with where to send Americans evacuated from the Diamond Princess cruise ship who tested positive for the virus after backing off plans to quarantine them in a federal facility in Alabama.

In a statement on Monday, HHS cited a “rapidly evolving situation,” but said that the Alabama center was “not needed at this time” and that it was looking for alternatives.

“Any action that HHS takes, working with our federal, state and local partners, to address this public health emergency will be done in a way that protects both those infected with the virus and other citizens as well,” HHS said.

(Reporting by Susan Heavey and Jeff Mason; Additional reporting by Caroline Humer in New York, and Makini Brice, Doina Chiacu, Tim Ahmann and Ted Hesson in Washington; Editing by Chizu Nomiyama, Bill Berkrot and David Gregorio)

Trump-backed ‘conscience’ rule for healthcare workers voided by U.S. judge

Trump-backed ‘conscience’ rule for healthcare workers voided by U.S. judge
By Jonathan Stempel

NEW YORK (Reuters) – A federal judge on Wednesday voided a White House-backed rule that would have made it easier for doctors and nurses to avoid performing abortions on religious or moral grounds.

U.S. District Judge Paul Engelmayer in Manhattan said the so-called “conscience” rule was unconstitutionally coercive, by letting the U.S. Department of Health and Human Services (HHS) withhold billions of dollars of federal funding from healthcare providers unless they complied.

“Wherever the outermost line where persuasion gives way to coercion lies, the threat to pull all HHS funding here crosses it,” Engelmayer wrote in a 147-page decision.

The judge also said the rule conflicted with federal laws governing the obligations of employers to accommodate workers’ religious objections, and hospitals to provide emergency treatment to patients who could not afford it.

Engelmayer’s decision covered a lawsuit by New York state and 22 other states and municipalities, as well as two lawsuits by Planned Parenthood and other healthcare providers.

HHS and the U.S. Department of Justice did not immediately respond to requests for comment. The rule was scheduled to take effect on Nov. 22.

U.S. President Donald Trump, a Republican, has made expanding religious liberty a priority, and the conscience rule has drawn support from abortion opponents.

Neither the office of New York Attorney General Letitia James nor Planned Parenthood immediately responded to requests for comment.

The states and municipalities have said the rule could undermine their ability to provide effective healthcare, and upset their efforts to accommodate workers’ beliefs while ensuring that hospitals and other businesses treated patients effectively.

Opponents of the rule have also said it could deprive gay, transgender and other patients of needed healthcare because providers might be deemed less worthy of treatment.

HHS countered that the rule would help enforce “conscience protection” laws that have been on the books for decades.

Engelmayer said these provisions “recognize and protect undeniably important rights,” but the government’s rulemaking “was sufficiently shot through with glaring legal defects.”

The state and municipal plaintiffs are led by Democrats or often lean Democratic.

They also include New York City, Chicago and Washington, D.C.; the states of Colorado, Connecticut, Delaware, Hawaii, Illinois, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New Jersey, New Mexico, Oregon, Pennsylvania, Rhode Island, Vermont, Virginia and Wisconsin; and Cook County, Illinois.

The states’ case is New York et al v. U.S. Department of Health and Human Services et al, U.S. District Court, Southern District of New York, No. 19-04676.

(Reporting by Jonathan Stempel in New York; Editing by Chizu Nomiyama and Bill Berkrot)

U.S. government creates health division for ‘religious freedom’

By Toni Clarke

WASHINGTON (Reuters) – The U.S. government is seeking to further protect the “conscience and religious freedom” of health workers whose beliefs prevent them from carrying out abortions and other procedures, in an effort likely to please conservative Christian activists and other supporters of President Donald Trump.

The U.S. Department of Health and Human Services said on Thursday it will create a division within its Office of Civil Rights to give it “the focus it needs to more vigorously and effectively enforce existing laws protecting the rights of conscience and religious freedom.”

Healthcare workers, hospitals with religious affiliations, and medical students among others have been “bullied” by the federal government to provide these services despite existing laws on religious and conscience rights, the top HHS official said.

“The federal government has hounded religious hospitals…forcing them to provide services that violate their consciences,” Acting HHS Secretary Eric Hargan said. “Medical students too have learned to do procedures that violate their consciences.”

Politico reported on Wednesday that the department is aiming to give protections for workers who do not want to provide abortions, care for transgender patients seeking to transition, or perform other procedures because of moral or religious grounds.

The move is likely to upset reproductive rights advocates and some Democrats.

The division would enforce the legal protection and conduct compliance reviews, audits and other enforcement actions to ensure that health care providers are allowing workers with religious or moral objections to opt out.

The creation of the division is in accordance with an executive order signed by Trump last May called “Promoting Free Speech and Religious Liberty.” The order was followed by new rules aimed at removing a legal mandate that health insurance provide contraception.

(Additional reporting by Caroline Humer; Editing by Alistair Bell)

HHS Confirms Abortions Offered To Illegal Immigrants

The Department of Health and Human Services has admitted that illegal alien unaccompanied minors who have been given status to stay in the U.S. by the Obama Administration will be offered free abortions.

The HHS issued a regulation that does not specifically mention abortion as a required emergency medical service but an officials from Administration for Children and Families told CNSNews.com that abortion is one of those offered services.

“The ‘lawful pregnancy-related medical services’ includes abortion,” the email statement said.

The HHS regulations also includes giving emergency contraception such as Plan B.

“Care provider facilities must provide UC victims of sexual abuse timely, unimpeded access to emergency medical treatment, crisis intervention services, emergency contraception, and sexually transmitted infections prophylaxis, in accordance with professionally accepted standards of care, where appropriate under medical or mental health professional standards,” reads one regulation that must be followed by caregivers for the illegal immigrant children.

The Health and Human Service’s Office of Refuge Resettlement acknowledged there could be religious objections to the policy and they would try to work with them but the needs of the patient will be considered first.