Cambridge, Massachusetts-based Moderna is largely ahead of the game in the U.S. for developing a vaccine against COVID-19. On May 20, the company released
positive interim Phase I data from its clinical trial of mRNA-1273.
Yesterday, Anthony Fauci, director of the U.S. National Institute of
Allergy and Infectious Diseases (NIAID), which is collaborating on the
vaccine with Moderna, told the editor of the technical journal JAMA
that the vaccine’s Phase III trial is expected to launch in July. It
will evaluate 30,000 patients ranging in age as 18 years and include the
elderly.
Moderna’s vaccine uses unproven technology, mRNA. No therapy or
vaccine has been approved based on the technology yet. Messenger RNA
(mRNA) delivers the genetic code to the ribosomes where the protein is
manufactured. In the Moderna vaccine, which is similar to a gene
therapy, the mRNA codes for the virus’s Spike (S) protein. The patient’s
cells then manufacture the S protein, which triggers the body’s immune
system to recognize the virus itself.
The interim data released on May 20 was overall positive, although
not without its critics, who believe the data was very early and
incomplete. At that time the data was only two weeks old.
“That’s very early,” Anna Durbin, a vaccine researcher at Johns Hopkins University, told STAT. “We don’t know if those antibodies are durable.”
The Moderna press release also indicated that the antibody levels
observed were equal to or greater in the 100 ug dose than was seen in
patients who recovered from COVID-19. There’s not much context here,
because studies on recovered COVID-19 patients have shown a range that
is potentially influenced by the severity of the disease. For example,
John “Jack” Rose, a Yale University vaccine researcher told STAT
about a study in China demonstrating that in 175 recovered COVID-19
patients, 10 had no detectable neutralizing antibodies, while others had
very high antibody levels.
Of the Phase III trial, Fauci indicated that the majority of trial
participants will be between the ages of 18 and 55, but will include
elderly Americans that are most at risk of serious illness from
COVID-19.
“We are preparing the sites for the Phase III study,” he told Howard Bauchner, editor of JAMA. “The real business end of this all is the Phase III trial that starts in the first week in July.”
He also pointed out that NIAID, the federal government and Moderna
and other companies developing vaccines against COVID-19 are scaling up
manufacturing and producing vaccines in a gamble that the vaccines will
be safe and effective.
“We are going to start manufacturing doses of the vaccines way before
we even know the vaccine works,” Fauci said. “We may know whether it’s
efficacious by November or December. By that time, we hopefully would
have close to 100 million (doses).”
If the vaccine is safe and effective, they could have “a couple
hundred million” doses available in early 2021. Of course, if it turns
out to be a dud, they will have invested millions of dollars in a
product that will have to be discarded.
Although Moderna’s vaccine is the leader in development, Fauci noted
that several other companies, including AstraZeneca, which is working
with the University of Oxford, are also developing potentially
effective and safe vaccines. “There’s an array of at least four and
possibly five trials that I am aware of and directly or indirectly
involved in.”
President Trump’s Operation Warp Speed
has a goal of manufacturing 100 million doses of a vaccine against
COVID-19 by November, 200 million by December and 300 million by January
2021. This timeline doesn’t quite seem to match up with Fauci’s
statements, and the timeline depends on everything going right, which is
not a given. Operation Warp Speed has reduced a possible 93 vaccine
programs to 14 top candidates, with expectations they will be further
narrowed to six or eight.
Yesterday, Emergent BioSolutions, a contract development and manufacturing organization (CDMO), announced it
had entered a public-private partnership under Operation Warp Speed
worth about $628 million. Emergent will handle domestic production of
leading COVID-19 vaccine candidates through 2021.
In a recent poll by the Washington Post-ABC News, 7 in 10 Americans indicated they
would take a vaccine against COVID-19 if they were free and available
to everyone. It had a political divide, however, with slightly more than
8 in 10 Democrats reporting they would definitely or probably get the
vaccine, while slightly less than 6 in 10 Republicans said they would.
Independents were somewhere in between.
About 15% of those polled said they would not get vaccinated, even if
it is free and available to everyone. Among Republicans, that was
claimed by 24%. Half of those said they do not trust vaccines in general
and about a quarter of that group said a vaccine isn’t necessary in
this case.
https://www.biospace.com/article/fauci-moderna-covid-19-trial-phase-iii-to-begin-in-july-with-30-000-patients/
Wednesday, June 3, 2020
Fitbit rises after its ventilator gains emergency use authorization
Fitbit (NYSE:FIT) gains 1.8% in after-hours trading after its Fitbit Flow emergency ventilator is granted Emergency Use Authorization by the U.S. Food & Drug Administration for use during the COVID-19 crisis.
Fitbit Flow builds on standard resuscitator bags,
like those used by paramedics, with sophisticated instruments, sensors,
and alarms that work together to support automated compressions and
patient monitoring.
The company says it’s goal is to supply these
devices to health care systems around the world that do not have a
sufficient number of traditional commercial ventilators.
It’s in talks with state and federal agencies to
understand current domestic needs for emergency ventilators and plans to
work with U.S. and global aid organizations as well.
https://seekingalpha.com/news/3580229-fitbit-rises-1_8-after-ventilator-gains-emergency-use-authorizationNon-Warp Speed COVID-19 vaccine players under pressure
Certain COVID-19 vaccine developers that the Trump administration left out of the final round of Operation Warp Speed are under pressure on the loss of potential federal funding to support their development efforts.
Selected tickers: Vir Biotechnology (VIR -9.5%), Novavax (NVAX -13.6%), Dynavax (DVAX -4.4%), Altimmune (ALT -6.6%), BioNTech (BNTX -1.0%), Arcturus Therapeutics (ARCT -11.6%), Soligenix (SNGX), GeoVax Labs (OTCPK:GOVX -3.9%), Inovio Pharmaceuticals (INO -12.8%), iBio (IBIO -5.2%), Vaxart (VXRT -6.3%)
https://seekingalpha.com/news/3580197-non-warp-speed-covidminus-19-vaccine-players-under-pressureInovio hits speed bump in supply of COVID-19 vaccine candidate
Inovio Pharmaceuticals (NASDAQ:INO) has filed litigation in
a Pennsylvania court against VGXI and GeneOne Life Science (together
“VGXI”) aimed at forcing the latter to transfer its DNA plasmid
technology to INO’s contract manufacturers so they can produce
sufficient quantities of COVID-19 vaccine candidate INO-4800 for
clinical trials and potential supply to the market, if approved.
Under a December 2019 agreement, VGXI as been the
sole supplier of DNA plasmids to INO under “most favored” status
although there are no purchase commitments and pricing is determined on
per-order basis.
VGXI has informed INO that it lacks the capacity
to make the volume of material in the requested timeline and it will be
unable to make the plasmids for commercial sales of INO-4800. INO
subsequently engaged third-party contract manufacturers to fill the void
but they need VGXI’s technology to do so, a development that VGXI is
balking over.
https://seekingalpha.com/news/3580228-inovio-hits-speed-bump-in-supply-of-covidminus-19-vaccine-candidate
Fed Will Expand Municipal Lending Facility to More Localities
The Federal Reserve said Wednesday it would again broaden the number
of local governments from which it will buy debt through a forthcoming
lending program.
The central bank said it would allow all 50 states to designate two cities or counties to sell debts directly to the central bank’s program, creating an option for states with less populous municipalities to participate.
The central bank also said governors of all 50 states will be able to designate an additional two issuers whose revenues are derived from operating activities, such as airports, toll facilities, utilities or public transit, to be eligible to use the facility on their own.
The Fed had previously made the program available to all 50 states, the District of Columbia, and one borrower for each county of at least 500,000 people and city of at least 250,000 — or as many as 261 issuers. Those thresholds had already been revised once, down from earlier cutoffs of 2 million and 1 million.
The changes will allow more than 100 new potential issuers to access the emergency lending program, which was first announced in April.
The Fed said it expects the program to lend up to $500 billion, and that volume hasn’t changed despite the two expansions of the program. The central bank has faced pressure from some elected officials to allow smaller cities and counties to access the program.
https://www.marketscreener.com/news/Fed-Will-Expand-Municipal-Lending-Facility-to-More-Localities–30717289/
The central bank said it would allow all 50 states to designate two cities or counties to sell debts directly to the central bank’s program, creating an option for states with less populous municipalities to participate.
The central bank also said governors of all 50 states will be able to designate an additional two issuers whose revenues are derived from operating activities, such as airports, toll facilities, utilities or public transit, to be eligible to use the facility on their own.
The Fed had previously made the program available to all 50 states, the District of Columbia, and one borrower for each county of at least 500,000 people and city of at least 250,000 — or as many as 261 issuers. Those thresholds had already been revised once, down from earlier cutoffs of 2 million and 1 million.
The changes will allow more than 100 new potential issuers to access the emergency lending program, which was first announced in April.
The Fed said it expects the program to lend up to $500 billion, and that volume hasn’t changed despite the two expansions of the program. The central bank has faced pressure from some elected officials to allow smaller cities and counties to access the program.
https://www.marketscreener.com/news/Fed-Will-Expand-Municipal-Lending-Facility-to-More-Localities–30717289/
Gilead’s remdesivir could see $7 billion in annual sales on stockpiling boost: analyst
Gilead Sciences Inc
potential COVID-19 treatment, remdesivir, could bring in more than $7
billion in annual sales by 2022, spurred by governments stockpiling the
drug to guard against future outbreaks, SVB Leerink said on Wednesday.
Remdesivir has shown improvement in COVID-19 patients in clinical trials and has been cleared for emergency use in severely ill patients in the United States, India and South Korea. Some European nations are using it in compassionate use.
The U.S. drugmaker is yet to set a price for the drug that is currently being administered intravenously in hospitals.
SVB Leerink analyst Geoffrey Porges, who upgraded his rating on Gilead’s shares to “outperform”, estimates remdesivir to be priced at $5,000 per course in the United States, $4,000 per course in Europe and around $2,000 in other markets.
The estimate comes a month after Boston-based Institute for Clinical and Economic Review suggested a price of $4,500 per U.S. treatment course for 10 days.
Remdesivir is yet to win a formal U.S. approval and Porges said commercial sales of the drug could begin later this year. He expects government stockpiling to begin late next year and said half of the forecasted sales of nearly $7.7 billion in 2022 could come from stockpiling contracts.
“We do forecast gradual adoption of vaccination, but in our view that is unlikely to stop government stockpiling of remdesivir,” Porges wrote in a client note.
Last month, brokerage SunTrust Robinson Humphrey estimated global sales of the drug to be around $3 billion by 2022. That assumes a U.S. price of around $10,000 per treatment course, but potential competition from other therapies and vaccines.
Given the vast number of COVID-19 infections, pricing remdesivir at around $1,000 per course could still mean over $1 billion in revenue, brokerage Jefferies had said last month.
https://www.marketscreener.com/GILEAD-SCIENCES-4876/news/Gilead-s-remdesivir-could-see-7-billion-in-annual-sales-on-stockpiling-boost-analyst-30717121/?countview=0
Remdesivir has shown improvement in COVID-19 patients in clinical trials and has been cleared for emergency use in severely ill patients in the United States, India and South Korea. Some European nations are using it in compassionate use.
The U.S. drugmaker is yet to set a price for the drug that is currently being administered intravenously in hospitals.
SVB Leerink analyst Geoffrey Porges, who upgraded his rating on Gilead’s shares to “outperform”, estimates remdesivir to be priced at $5,000 per course in the United States, $4,000 per course in Europe and around $2,000 in other markets.
The estimate comes a month after Boston-based Institute for Clinical and Economic Review suggested a price of $4,500 per U.S. treatment course for 10 days.
Remdesivir is yet to win a formal U.S. approval and Porges said commercial sales of the drug could begin later this year. He expects government stockpiling to begin late next year and said half of the forecasted sales of nearly $7.7 billion in 2022 could come from stockpiling contracts.
“We do forecast gradual adoption of vaccination, but in our view that is unlikely to stop government stockpiling of remdesivir,” Porges wrote in a client note.
Last month, brokerage SunTrust Robinson Humphrey estimated global sales of the drug to be around $3 billion by 2022. That assumes a U.S. price of around $10,000 per treatment course, but potential competition from other therapies and vaccines.
Given the vast number of COVID-19 infections, pricing remdesivir at around $1,000 per course could still mean over $1 billion in revenue, brokerage Jefferies had said last month.
https://www.marketscreener.com/GILEAD-SCIENCES-4876/news/Gilead-s-remdesivir-could-see-7-billion-in-annual-sales-on-stockpiling-boost-analyst-30717121/?countview=0
White House picks five COVID vaccine candidates for Warp Speed initiative
Aimed at following through on its pledge to have a COVID-19 vaccine available in the next 2-3 quarters under Operation Warp Speed, the Trump administration has selected five “finalists” for development.
Moderna (MRNA +3.8%): Phase 2 study of mRNA-1273 underway.
AstraZeneca (AZN +0.5%) with Oxford University: Studies in UK underway on AZD1222.
Johnson & Johnson (JNJ -0.1%): Phase 1 study to launch in September at the latest.
Merck (MRK +1.6%): No dates yet announced for trials.
Pfizer (PFE -0.9%): “Hundreds of millions” of doses to be available this year.
MRNA, AZN/Oxford and JNJ have already received
$2.2B in federal funding. All five will have access to additional
financial support to quickly advance their candidates.
About 30K people will take part in Phase 3 trials, meaning that a total of 150K people could be vaccinated.
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