Tag Archives: clinical trial

Novavax COVID-19 vaccine more than 90% effective in U.S. trial

By Carl O’Donnell

(Reuters) – Novavax Inc on Monday reported late-stage data from its U.S.-based clinical trial showing its vaccine is more than 90% effective against COVID-19 across a variety of variants of the virus.

The study of nearly 30,000 volunteers in the United States and Mexico puts Novavax on track to file for emergency authorization in the United States and elsewhere in the third quarter of 2021, the company said.

Novavax’s protein-based COVID-19 vaccine candidate was more than 93% effective against the predominant variants of COVID-19 that have been of concern among scientists and public health officials, Novavax said.

Protein-based vaccines are a conventional approach that use purified pieces of the virus to spur an immune response and vaccines again whooping cough and shingles employ this approach.

During the trial, the B.1.1.7 variant first discovered in the United Kingdom became the most common variant in the United States, it said.

Novavax also detected variants of COVID-19 first found in Brazil, South Africa and India among its trial participants, Novavax’s head of research and development, Dr. Gregory Glenn, told Reuters.

The vaccine was 91% effective among volunteers at high risk of severe infection and 100% effective in preventing moderate and severe cases of COVID-19. It was roughly 70% effective against COVID-19 variants that Novavax was unable to identify, Glenn said.

“Practically speaking, it’s very important that the vaccine can protect against a virus that is wildly swinging around” in terms of new variants, Glenn said.

Novavax said the vaccine was generally well tolerated among participants. Side effects included headache, fatigue and muscle pain and were generally mild. A small number of participants experienced side effects described as severe.

Novavax remains on track to produce 100 million doses per month by the end of the third quarter of 2021 and 150 million doses per month in the fourth quarter of 2021, the company said.

The Maryland-based company has repeatedly pushed back production forecasts and has struggled to access raw materials and equipment needed to make its vaccine.

However, in a May investor call, Chief Executive Stanley Erck said major manufacturing hurdles have been cleared and that all of its facilities can now produce COVID-19 vaccine at commercial scale.

Erck said that Novavax has begun its regulatory filing in India in partnership with the Serum Institute of India, which is contracted to make Novavax shots.

Erck said his understanding is that SII is no longer constrained by raw materials shortages.

SII had said in March that U.S. restrictions on exports of supplies used for vaccines were limiting its ability to scale up production.

(Reporting by Carl O’Donnell; Editing by Lisa Shumaker)

Philippines to start clinical trials on ivermectin, other drugs for COVID-19

By Reuters Staff

MANILA (Reuters) – The Philippines will begin clinical trial of several drugs, including the anti-parasite medication ivermectin, in patients with COVID-19 to determine their efficacy in combatting the coronavirus, a senior government official said.

Some politicians in the Philippines have started promoting the use of ivermectin for coronavirus and given out free doses, although the country’s food and drugs regulator has cautioned against the use because of a lack of evidence for the drug as a treatment.

The clinical trial for ivermectin, which could last for six months, “will give us a more reliable estimate of the effects of invermectin as an anti-viral agent in mild and moderate (COVID-19) patients,” science and technology minister, Fortunato Dela Pena, said in a presentation late on Monday.

The Southeast Asian nation, which is facing one of the worst coronavirus outbreaks in Asia, is battling a renewed surge in infections, with its vaccination drive on reaching 1.3 million people out of its more than 108 million population.

Ivermectin tablets have been approved for treating some worm infestations and for veterinary use in animals for parasites.

The World Health Organization last month recommended against using ivermectin in patients with COVID-19 except for clinical trials, because of a lack of data demonstrating its benefits.

The European Medicines Agency, U.S. Food and Drug Administration, and Merck, an ivermectin manufacturer, have also recommended against its use.

Dela Pena said the government has also approved the clinical trials of a new formulation of methylprednisolone, a steroid, and melatonin, as treatments for COVID-19.

The government will also start trials of an herbal supplement, derived from the native tawa-tawa plant that can fight dengue, he said, adding to ongoing tests using virgin coconut oil for severe COVID-19 patients.

“We are trying several (medications). They may not be vaccines but they could potentially speed up the recovery,” Dela Pena said.

The Philippines has recorded more than 945,000 COVID-19 cases and over 16,000 deaths, the second highest rates in Southeast Asia, next to Indonesia.

U.S. infectious disease group backs Gilead’s remdesivir for COVID-19 treatment

By Rebecca Spalding

(Reuters) – The top U.S. infectious disease medical association said on Monday that Gilead Sciences Inc’s antiviral drug remdesivir should be used for hospitalized COVID-19 patients despite a World Health Organization (WHO) recommendation last week against its use.

The Infectious Diseases Society of America (IDSA) in updated guidelines said its experts back the drug for use in severe COVID-19 patients based on a clinical trial showing it reduced hospital stays. The WHO study that led to its recommendation against the drug suggested it had no benefit in saving lives or reducing the need for mechanical breathing assistance.

“As hospitals around the United States fill up, the IDSA panel views the effect of remdesivir speeding up time to recovery to be an important benefit,” Dr. Rajesh Gandhi, co-chair of the society’s COVID-19 treatment and management guidelines expert panel, said on a call with reporters. “Better medicines that improve survival are clearly needed.”

Unlike the trial that led to its U.S. regulatory approval, the WHO’s study was not placebo-controlled. Studies with a placebo comparison are generally considered more scientifically rigorous than those without a control group.

The IDSA also has advised against the routine use of Eli Lilly and Co’s COVID-19 antibody treatment bamlanivimab, which received U.S. emergency use authorization. The IDSA panel said it recommended against its routine use for ambulatory patients, but that it may still be appropriate for patients with increased risks after a discussion with their doctor.

“Antibodies may end up having a role. I think we just need more definitive data,” Dr. Gandhi said. “I want to keep our eye on what benefit they may end up having as well as which patients are most likely to benefit.”

It said Roche Holdings Ag’s rheumatoid arthritis drug Actemra, known chemically as tocilizumab, is not recommended for routine use in hospitalized COVID-19 patients, saying there was still not enough evidence supporting its benefits.

(Reporting by Rebecca Spalding; Editing by Bill Berkrot)

‘Great day for humanity’: Pfizer says COVID-19 vaccine over 90% effective

By Michael Erman and Julie Steenhuysen

(Reuters) – Pfizer Inc’s experimental COVID-19 vaccine is more than 90% effective based on initial trial results, the drugmaker said on Monday, a major victory in the war against a virus that has killed over a million people and battered the world’s economy.

Experts welcomed the first successful interim data from a large-scale clinical test as a watershed moment that showed vaccines could help halt the pandemic, although mass roll-outs, which needs regulatory approval, will not happen this year.

Pfizer and German partner BioNTech SE said they had found no serious safety concerns yet and expected to seek U.S. authorization this month for emergency use of the vaccine, raising the chance of a regulatory decision as soon as December.

If granted, the companies estimate they can roll out up to 50 million doses this year, enough to protect 25 million people, and then produce up to 1.3 billion doses in 2021.

“Today is a great day for science and humanity,” said Pfizer Chief Executive Albert Bourla.

“We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen,” he said.

Experts said they still wanted to see the full trial data, which have yet to be peer-reviewed or published in a medical journal, but the preliminary results looked encouraging.

“This news made me smile from ear to ear. It is a relief to see such positive results on this vaccine and bodes well for COVID-19 vaccines in general,” said Peter Horby, professor of emerging infectious diseases at the University of Oxford.

There are still many questions, such as how effective the vaccine is by ethnicity or age, and how long it will provide immunity, with the “new normal” of social distancing and face covering set to remain for the foreseeable future.

Pfizer expects to seek U.S. emergency use authorization for people aged 16 to 85. To do so, it will need two months of safety data from about half the study’s 44,000 participants, which is expected in the third week of November.

U.S. Health and Human Services Secretary Alex Azar said it would take several weeks for U.S. regulators to receive and process data on the vaccine before the government could potentially approve it.

MARKETS SURGE

The prospect of a vaccine electrified world markets with the S&P 500 and Dow hitting record highs as shares of banks, oil companies and travel companies soared. Shares in companies that have thrived during lockdowns, such as conferencing platform Zoom Video and online retailers, tumbled.

Pfizer shares jumped more than 11% to their highest since July last year, while BioNTech’s stock hit a record high.

Shares of other vaccine developers in the final stage of testing also rose with Johnson & Johnson up 4% and Moderna Inc, whose vaccine uses a similar technology as the Pfizer shot, up 8%. Britain’s AstraZeneca, however, fell 2%. Moderna is expected to report results from its large-scale trial later this month.

“The efficacy data are really impressive. This is better than most of us anticipated,” said William Schaffner, infectious diseases expert at Vanderbilt University School of Medicine in Nashville, Tennessee. “The study isn’t completed yet, but nonetheless the data look very solid.”

U.S. President Donald Trump welcomed the test results, and the market boost: “STOCK MARKET UP BIG, VACCINE COMING SOON. REPORT 90% EFFECTIVE. SUCH GREAT NEWS!” he tweeted.

President-elect Joe Biden said the news was excellent but did not change the fact that face masks, social distancing and other health measures would be needed well into next year.

The World Health Organization said the results were very positive, but warned there was a funding gap of $4.5 billion that could slow access to tests, medicines and vaccines in low- and middle-income countries.

‘NEAR ECSTATIC’

“I’m near ecstatic,” Bill Gruber, one of Pfizer’s top vaccine scientists, said in an interview. “This is a great day for public health and for the potential to get us all out of the circumstances we’re now in.”

Between 55% and 65% of the population will need to be vaccinated to break the dynamic of the spread of COVID-19, said Germany’s health minister Jens Spahn, adding that he did not expect a shot to be available before the first quarter of 2021.

The European Union said on Monday it would soon sign a contract for up to 300 million doses of the Pfizer and BioNTech COVID-19 vaccine.

The companies have a $1.95 billion contract with the U.S. government to deliver 100 million vaccine doses beginning this year. They did not receive research funding from the Trump administration’s Operation Warp Speed vaccine program.

The drugmakers have also reached supply agreements with the United Kingdom, Canada and Japan.

Pfizer said the interim analysis, conducted after 94 participants in the trial developed COVID-19, examined how many had received the vaccine versus a placebo.

Pfizer did not break down how many of those who fell ill received the vaccine. Still, over 90% effectiveness implies that no more than 8 of the 94 had been given the vaccine, which was administered in two shots about three weeks apart.

The efficacy rate, which could drop once full results are available, is well above the 50% effectiveness required by the U.S. Food and Drug Administration for a coronavirus vaccine.

Shortly after Pfizer’s announcement, Russia said its Sputnik V vaccine was also more than 90% effective, based on data collated from inoculations of the public. Its preliminary Phase III trial data is due to be published this month.

MORE DATA NEEDED

To confirm the efficacy rate, Pfizer said it would continue its trial until there were 164 COVID-19 cases among volunteers. Bourla told CNBC on Monday that based on rising infection rates, the trial could be completed before the end of November.

Pfizer said its data would be peer reviewed once it has results from the entire trial.

“These are interesting first signals, but again they are only communicated in press releases,” said Marylyn Addo, head of tropical medicine at the University Medical Center Hamburg-Eppendorf in Germany.

Dozens of drugmakers and research groups around the globe have been racing to develop vaccines against COVID-19, which on Sunday exceeded 50 million cases since the new coronavirus first emerged late last year in China.

The Pfizer and BioNTech vaccine uses messenger RNA (mRNA) technology, which relies on synthetic genes that can be generated and manufactured in weeks, and produced at scale more rapidly than conventional vaccines. The technology is designed to trigger an immune response without using pathogens, such as actual virus particles.

The Trump administration has said it will have enough vaccine doses for all of the 330 million U.S. residents who want it by the middle of 2021.

(Reporting by Michael Erman and Julie Steenhuysen; Additional reporting by Michele Gershberg in New York, Ludwig Burger and Patricia Weiss in Frankfurt and Kate Kelland in London; Editing by Bill Berkrot, Caroline Humer, Edwina Gibbs and David Clarke)

NIH launches trial of Rigel drug for severe COVID-19

By Deena Beasley

(Reuters) – The U.S. National Institutes of Health on Thursday launched a clinical trial of fostamatinib, currently used to treat a blood platelet-destroying autoimmune disorder, in patients hospitalized with severe COVID-19, the disease caused by the novel coronavirus.

The tablets, sold under the brand name Tavalisse by Rigel Pharmaceuticals Inc, have shown in lab and animal studies the ability to block production of sticky, web-like substances that the immune system produces to trap foreign invaders.

For reasons that are still not clearly understood, the immune systems of some COVID-19 patients can overreact, creating an inflammatory cascade that can be toxic to organs, cause blood clots and worsen pneumonia.

Fostamatinib is designed to block activity of an enzyme that regulates parts of the body’s immune response, including “neutrophil extracellular traps,” or NETs, that white blood cells release to ensnare and kill pathogens.

“I am most excited about this drug because I know that as a targeted therapy it inhibits NETs, which we think is a big contributor to mortality,” said Dr. Richard Childs, clinical director of the National Heart, Lung, and Blood Institute.

The randomized, placebo-controlled Phase 2 trial will enroll 60 patients at the NIH Clinical Center in Bethesda, Maryland, Inova Health System’s Northern Virginia hospital and possibly other Inova locations.

The primary objective is evaluation of safety.

The trial is likely to take two or three months, and Rigel is considering how a larger study might be conducted, said Raul Rodriguez, the company’s chief executive officer.

Other immune system-modulating drugs are being used in COVID-19 patients, including the decades-old steroid dexamethasone, which is so far the only medication shown to improve their chance of survival.

“The problem is the steroid is a non-targeted therapy. It will also hit parts of the immune system that are very important for fighting off the virus or other infections,” Childs said. “Some patients that get COVID will get a bacterial infection … we see that all the time with influenza.”

Researchers at Imperial College London are also running an open-label study of fostamatinib in patients with COVID-19 pneumonia.

The drug is approved in the United States and Europe for treating adult chronic immune thrombocytopenia, a rare autoimmune disorder in which the body’s immune system destroys healthy platelets, leading to easy or excessive bruising and bleeding.

(Reporting by Deena Beasley; Editing by Timothy Gardner)

Novavax starts enrollment for phase two of COVID-19 vaccine trial

(Reuters) – Novavax Inc said on Monday it has begun enrolling volunteers for the second phase of an ongoing clinical trial of its COVID-19 vaccine candidate, with interim data expected in the fourth quarter of 2020.

In the new phase, the age range has been expanded, with adults between 60 and 84 years accounting for nearly 50% of the trial’s population.

Early-stage data from a small clinical trial of the vaccine has shown it produced high levels of virus-fighting antibodies, and the company aims to begin larger studies to obtain regulatory approvals as early as December.

The vaccine candidate is one of nearly 30 being tested in human clinical trials globally and lags candidates from AstraZeneca, Pfizer and Moderna that are in late-stage studies.

The U.S. government in July awarded Novavax $1.6 billion to test and manufacture its vaccine in the United States, with the aim of delivering a 100 million doses by January.

Britain has also tied-up with the company to buy 60 million doses of its vaccine candidate, some of which will be made using Fujifilm Diosynth Biotechnologies facilities in Stockton-on-Tees, northern England.

The study is targeting enrollment of up to 1,500 healthy volunteers at up to 40 sites in the United States and Australia, Novavax said.

Last week, the drug developer began a mid-stage study of its COVID-19 vaccine in South Africa.

(Reporting by Ankur Banerjee and Vishwadha Chander in Bengaluru; Editing by Arun Koyyur)

Moderna expects to start late-stage COVID-19 vaccine trial on July 27

NEW YORK (Reuters) – Moderna Inc said on Tuesday it plans to start a late stage clinical trial for its COVID-19 vaccine candidate on or around July 27, according to its listing for the phase 3 study at clinicaltrials.gov.

Moderna said it will conduct the trial at 87 study locations, all in the United States.

The experimental vaccine will be tested in 30 states and Washington, D.C. Around half of the study locations are in hard-hit states like Texas, California, Florida, Georgia, Arizona and North and South Carolina.

The United States has reported record numbers of new coronavirus cases in recent days, with much of the surge coming from those states.

The federal government is supporting Moderna’s vaccine project with nearly half a billion dollars and has chosen it as one of the first to enter large-scale human trials.

Tensions between the company and government scientists contributed to a delay of the trial launch, Reuters reported earlier this month.

Shares of Moderna rose about 2.5% on Nasdaq at midday.

(Reporting by Michael Erman, Editing by Franklin Paul and Richard Chang)