Possible safety issues pause antibody study
NEW YORK, Oct 14, (AP): Independent monitors have paused enrollment in a study testing the COVID-19 antiviral drug remdesivir plus an experimental antibody therapy being developed by Eli Lilly that’s similar to a treatment President Donald Trump recently received.
Lilly confirmed Tuesday that the study had been paused “out of an abundance of caution” and said safety is its top concern. The company would not say more about what led to this step.
The US National Institute of Allergy and Infectious Diseases, which sponsors the study, would not immediately comment.
Antibodies are proteins the body makes when an infection occurs; they attach to a virus and help it be eliminated. The experimental drugs are concentrated versions of one or two specific antibodies that worked best against the coronavirus in lab and animal tests.
This study was testing a single antibody that Lilly is developing with the Canadian company AbCellera. Trump received an experimental two-antibody combo drug from Regeneron Pharmaceuticals Inc.
Lilly and Regeneron have asked the US Food and Drug Administration to grant emergency use authorization for their drugs for COVID-19 while latestage studies continue.
The paused study, called ACTIV-3, started in August and aims to enroll 10,000 hospitalized COVID-19 patients in the United States, Denmark and Singapore. All are given remdesivir, which has been authorized in the US as an emergency treatment for COVID-19, plus either the Lilly antibody or a placebo.
The main goals are reducing the need for extra oxygen and time to recovery. Deaths, relief of symptoms and other measures also are being tracked. All of the drugs are given through an IV.
Such pauses are not uncommon in long clinical studies. Unlike a study hold imposed by government regulators, a pause is initiated by the sponsor of the drug trial and often can be quickly resolved.
The pause in the Lilly study comes a day after a temporary halt to enrollment in a coronavirus vaccine study. Johnson & Johnson executives said Tuesday that it will be a few days before they know more about an unexplained illness in one participant that caused a pause in its late-stage vaccine study. Johnson & Johnson isn’t disclosing the nature of the illness.
“It may have nothing to do with the vaccine,” said Mathai Mammen, head of research and development for Janssen, Johnson & Johnson’s medicine development business.
Mammen said the company doesn’t know yet whether the ill participant received the experimental vaccine or a dummy shot. He says Johnson & Johnson gave information on the case to the independent monitoring board overseeing the safety of patients in the study, as the research protocol requires. It will recommend next steps.
The study of the one-dose vaccine will include up to 60,000 people from multiple countries. The company expects to complete enrollment in the study in two or three months.
Vaccines: The World Bank has approved $12 billion in financing to help developing countries buy and distribute coronavirus vaccines, tests, and treatments, aiming to support the vaccination of up to 1 billion people.
The $12 billion “envelop” is part of a wider World Bank Group package of up to $160 billion to help developing countries fight the COVID-19 pandemic, the bank said in a statement late Tuesday.
The World Bank said its COVID-19 emergency response programs are already reaching 111 countries.
Citizens in developing countries also need access to safe and effective COVID-19 vaccines, it said.
“We are extending and expanding our fast-track approach to address the COVID emergency so that developing countries have fair and equal access to vaccines,” said the bank’s president, David Malpass, said in the statement.
“Access to safe and effective vaccines and strengthened delivery systems is key to alter the course of the pandemic and help countries experiencing catastrophic economic and fiscal impacts move toward a resilient recovery,” he said.
The International Finance Corporation, the private sector lending arm of the World Bank is investing in vaccine manufacturers through a $4 billion Global Health Platform, the statement said.
Development and deployment of vaccines is crucial to helping stem outbreaks of the coronavirus that has killed more than 1 million people and sickened more than 38 million, while devastating economies and leaving many millions jobless.
The World Bank said it will draw on expertise and experience from its involvement in many large-scale immunization programs and other public health efforts.
The funding is meant to also help countries access tests and treatments and to support management of supply chains and other logistics for vaccinations in developing countries, the bank said.
Flu: France launched a flu vaccine campaign Tuesday in an effort to avoid facing another epidemic peak as the coronavirus is spreading rapidly in the country.
French health authorities have issued official recommendations to prevent potential shortages of flu vaccine, which they fear might happen amid increased demand because of the COVID-19 pandemic.
Medical staff are advised to initially reserve it for priority patients, including people over 65, pregnant women and those suffering from respiratory illness and some other diseases. Others are advised to wait for December.
The campaign was launched as French health authorities report a rapid increase in cases of coronavirus infections, with more and more people admitted in hospitals. COVID-19 patients now occupy more than 42% of intensive care unit beds in the Paris region.
Sylvie Ducamp, 73, was among the first patients to get the flu vaccine at a Paris pharmacy on Tuesday morning.
“Getting the flu shot allows you not to confuse flu symptoms with COVID-19 symptoms and it helps the doctors,” she told The Associated Press.
Karima Ameri, 45, said her doctor advised her to get the vaccine quickly to avoid a potential shortage “because more and more people want to be vaccinated precisely out of fear of being weakened by the flu” and contracting COVID-19.
Pharmacist assistant Amira Ben Guitar said “we prepared adequate supplies of the vaccine, in this pharmacy, we have prepared adequate stock. The only fear that we can have is if there are more people who want to be vaccinated than in previous years.”
Health Minister Olivier Veran said that France ordered 15.5 million of vaccine doses - an increase of 30% compared to last year.
Last winter, about 52% of people over age 65 received the flu vaccine, according to French health authorities. This year, French authorities have set a goal to reach up to 75%.
Also:
OAKLAND, Calif.: Facebook says it will ban ads on its platform that discourage vaccinations - with an exception carved out for advocacy ads about government vaccine policies.
The company already bans ads about vaccine “hoaxes,” such as the false idea that vaccinations cause autism. The latest policy expands the ban to ads that discourage vaccines for any reason.
But Facebook also said Tuesday that ads that “advocate for or against legislation or government policies around vaccines” - including a COVID-19 vaccine - will still be allowed. These ads will still have to be approved by the company as political advertisements and include a “paid for by” label on who is funding them.
And unpaid posts by people or groups that discourage vaccinations will also still be allowed - the new policy only includes paid advertisements.