Covid-19 roundup: Pfizer, BioNTech start US human trial; World leaders (not including the US) pledge $8 billion in vaccine, treatment research
Last week, partners Pfizer and BioNTech joined the elite group of CanSino, Moderna and Oxford who have begun human trials of their experimental Covid-19 vaccine. On Tuesday, the US-German partners kicked off dosing in the United States.
The team, which kicked off dosing in Germany in late April, said the first US participants had been given a vaccine from the BNT162 program in a Phase I/II trial. The vaccine program includes four experimental vaccines — each with combination of mRNA format and target antigen — the design of the trial will allow for the evaluation of the various candidates simultaneously so that the safest and potentially most efficacious candidate can be identified.
“The short, less than four-month timeframe in which we’ve been able to move from pre-clinical studies to human testing is extraordinary…” said Pfizer chief Albert Bourla in a statement.
The Phase I/II study is set to enroll up to 360 healthy subjects into two age cohorts (18-55 and 65-85 years of age) — the subjects immunized in the first portion of the study will be healthy adults 18-55 years of age. Older adults will only be immunized with a given dose level of a vaccine candidate, once testing in younger adults offers initial evidence of safety and immunogenicity.
From the manufacturing side, the partners are scaling up production. Millions of vaccine doses should be available in 2020, and those numbers should grow to hundreds of millions by next year, the companies said.
World leaders, barring the US, pledge $8 billion in vaccine, treatment research — report
Last month, President Donald Trump said he would stop funding the WHO, taking issue with the way the organization has been tackling the pandemic. Now, the United States is steering clear of a global effort to support vaccine and treatment development.
On Monday, world leaders vowed to raise $8 billion to kickstart the effort, to build on efforts by the World Bank, the Bill and Melinda Gates Foundation and wealthy individuals, Reuters reported. The event was organized by the European Union and non-EU countries Britain, Norway and Saudi Arabia, and included the participation of Japan, Canada, South Africa and China, among others.
A senior US administration official declined to tell the wire service specifically why the United States was not participating.
The successful development of a vaccine is only the first step — easy access globally will be the next big hurdle. EU officials said that the funding will not strip the recipient pharmaceutical companies of intellectual property on any vaccine or treatment, but companies will be expected to commit to making them available at affordable prices.
Many leaders stressed that any vaccine must be made available to everyone. Canadian Prime Minister Justin Trudeau said it should not just be for rich countries.
“Those who invent it, of course, will be fairly paid, but access will be given to people across the globe by the organization we choose,” French President Emmanuel Macron said, according to the Reuters report.
The issue of how a vaccine will be distributed across the globe, if proved safe and effective, is paramount. In a Wall Street Journal opinion piece late last month entitled “America needs to win the coronavirus vaccine race,” former FDA chief Scott Gottlieb warned that “while friendly nations will try to share a successful product — to a point — the US can’t rely on vaccines from China or even Europe being available in America quickly.”
Last week, Bloomberg reported that the Trump administration is working on executing a multibillion-dollar plan “Operation Warp Speed” to assure that 300 million doses (of any potential vaccine) — which should cover nearly the entire US population — are available by January, the earliest timeline charted by vaccine developers. Although the details are sparse, the plan brings pharmaceutical companies, government agencies and the military to coordinate testing of experimental vaccines and involves large investments in manufacturing.
The vaccine partnership between Oxford, AstraZeneca and Vaccitech — which aims to make 100 million doses by the end of 2020 — includes provisions to distribute the vaccine to low and medium-income countries, although the details are sparse.
Separately, the Serum Institute of India that has also partnered with Oxford scientists to mass-produce their vaccine (with plans to produce up to 60 million doses this year) told Reuters that their first priority is India and its population of 1.3 billion. A majority of the vaccine, at least initially, would have to go to our countrymen before it goes abroad,” Serum CEO Adar Poonawalla said.
Gilead’s promising Covid-19 antiviral remdesivir gets Bangladeshi producer — report
The company, which has previously pledged to donate its existing supply of 1.5 million individual doses of remdesivir for use in patients in clinical trials and on a compassionate use basis, has reportedly found a new supplier in the form of one of Bangladesh’s largest drugmakers, Beximco Pharmaceuticals.
The antiviral, which failed to pass muster as an Ebola therapy, quickly rose to prominence as a potential Covid-19 drug after inducing a statistically significant impact in helping hospitalized Covid-19 patients recover faster in a randomized, placebo-controlled study — the gold-standard for benefit-risk calculations. Although more data are incoming, the drug was granted emergency use authorization by the FDA on Friday.
Apart from the $50 million the company has already invested in developing the drug, another $1 billion is expected to be spent, as Gilead ramps up further development and manufacturing of remdesivir in anticipation of regulatory approvals, executives said in a recent conference call.
Beximco plans to price the drug at between 5000 and 6000 takas per vial ($59-$71/per vial), Beximco’s Chief Operating Officer Rabbur Reza told Reuters, adding a patient might need anywhere between 5 and 11 vials.
“We will only know exactly how much a patient needs once studies are complete,” Reza said, noting that production would begin this month, initially for domestic use.
Models predict American daily death rate to hit 3,000 by June
As part of the United States get ready to ease back into normality, the University of Washington’s Institute for Health Modeling and Evaluation says the coronavirus pandemic will claim nearly 135,000 American lives by August, in part due to states easing their social distancing restrictions.
The projection is grim for the coming weeks. IHME predicts that there will be as many as 3,000 deaths per day in by June 1, with a sharp peak hitting around mid-May — well ahead of the current pace of about 1,500 daily deaths.
Another draft report projected Covid-19 cases will surge to about 200,000 per day by June 1, with 3,000 deaths expected per day, the Washington Post reported. The White House and the CDC disavowed the report, although the slides do carry the CDC’s logo, the Post said, adding that the creator of the model said the numbers are unfinished projections shown to the CDC as a work in progress.
SEC investigation triggers suspension of Moleculin Biotech’s stock
Every few years, a public health crisis (think Ebola, Zika) spurred by a rogue pathogen triggers a small-biotech rally, as drugmakers emerge from the woodwork with ambitious plans to treat the mounting outbreak. In most cases, that enthusiasm never quite delivers.
With Covid-19 having ravaged much of the globe, the ever opportune biotech is always around the corner.
On Monday, Texas cancer-focused biotech Moleculin said its shares had been placed in a temporary trading halt following notification from the SEC.
The small company, which has a market cap of about $65 million, has been making statements in a smattering of regulatory filings and press releases since March 19 suggesting its experimental drug, WP1122, was a potential candidate for use in Covid-19 and that it could expedite the regulatory approval of the treatment. Between March 18 and May 1st (when the trading suspension came into effect), the value of the company’s stock has more than doubled to $1.o7.
The suspension will terminate at 11:59 p.m. ET on May 15th, 2020. Moleculin said it believes it will be able to demonstrate the accuracy and adequacy of its public disclosures.
Milken Institute tracker identifies loads more Covid-19 treatment and vaccine candidates in development
In early March, the think tank had tracked 55 treatments and 38 vaccine candidates. Fast forward to May 4, those numbers have jumped to more than 111 vaccines and 197 treatments in the pipeline to treat and prevent Covid-19.
Of this burgeoning group, nine vaccines and more than 50 treatments currently are in clinical trials.
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