What is happening.
COVID vaccine rollout, a colossal mess.
Ed Yong, The Atlantic:
“I think there has been a certain amount of naïveté on the part of the government about what it actually takes to turn vaccines into vaccinations,” he says. “Unless we actually put more funding into this particular area, it’s going to be a bit tragic, because we’re going to have vaccines, but we’re going to fall at the last hurdle.” [NPR]
[by Rachel Roberts]
“Idaho will not receive as many doses of the Pfizer COVID-19 vaccine next week as it originally expected, according to the Idaho Department of Health and Welfare.
Idaho’s allotment for next week was reduced from 17,550 to 9,750 doses.
Idaho isn’t the only state reporting a reduced second shipment, according to reports from The Washington Post and other news outlets. Florida, Illinois, Iowa, Kansas, Missouri, Oregon, Rhode Island and Washington were among the other states receiving fewer vaccines.”
From Politifact/Poynter Institute:
“Vice President Mike Pence tweeted: “On January 13, 2020 @moderna_tx partnered with President @realDonaldTrump & @NIH to develop a vaccine for the American people! Today, Moderna announced their vaccine is 95% EFFECTIVE! Operation Warp Speed is a success because of the strong leadership of this President!”
In their own recent announcements, Moderna gave Operation Warp Speed a nod, while Pfizer didn’t mention it. That can be explained by the different partnerships the Trump administration struck with the two companies.
The federal government’s deal with Pfizer would pay for the purchase of the company’s vaccine if it gets FDA emergency use authorization or approval. So Pfizer hasn’t gotten any Warp Speed funding yet. With Moderna and other companies, by contrast, the government is helping to fund the vaccines’ development and various efforts to scale up manufacturing.
Those differences may influence who can claim the credit for the breakthroughs at this stage.”
[By Ellie Kaufman, Sara Murray and Priscilla Alvarez]
“Multiple states have been told by the federal government to expect fewer doses of Pfizer’s Covid-19 vaccine than initially promised, leaving health officials across the country confused and frustrated about the crucial rollout plans just days after the first doses were shipped.
Officials in numerous states including Iowa, Illinois, Washington, Michigan and Oregon have said that they have been recently told they would receive fewer doses than originally planned for by the federal government’s Operation Warp Speed.
The cause of delay remains unclear to many, and comes as infection rates are spiking across the country. On Thursday, Pfizer put out a statement that the company was “not having any production issues” and that “no shipments containing the vaccine are on hold or delayed.”
“We have millions more doses sitting in our warehouse but, as of now, we have not received any shipment instructions for additional doses,” Pfizer said.
[by Issac Arnsdorf]
ProPublica is a nonprofit newsroom that investigates abuses of power.
ProPublica’s board chairman, Paul Sagan, is a member of Moderna’s board and a company stockholder.
“Trump’s vaccine Czar refuses to give up stock in drug company involved in his government role.
The administration calls Moncef Slaoui, who leads its vaccine race, a “contractor” to sidestep rules against personally profiting from government positions. Slaoui owns $10 million in stock of a company working with his team to develop a vaccine.
“Congress should strengthen the federal ethics laws to root out this kind of corruption,” Sen. Elizabeth Warren, D-Mass., said at a congressional hearing. “And the first person to be fired should be Dr. Slaoui. The American people deserve to know that COVID-19 decisions are based on science and not on personal greed.”
[by Sony Salzman]
Though their journeys to a COVID-19 vaccine have been eerily similar, the companies themselves could not be more different Pfizer is a multinational pharmaceutical giant, while Moderna is a small biotechnology company that has never brought a drug to the market.
[by Marisa Taylor, Robin Respaut]
“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.
But the company – which has never produced an approved vaccine or run a large trial – has squabbled with government scientists over the process, delayed delivering trial protocols and resisted experts’ advice on how to run the study, according to three sources familiar with the vaccine project. The sources said those tensions, which have not been previously reported, have contributed to a delay of more than two weeks in launching the trial of the Moderna’s vaccine candidate, now expected in late July.
In one disagreement, Moderna executives resisted experts’ insistence on close monitoring of trial participants who might contract COVID-19 for changes in oxygen levels that could signal dangerous complications. While other drugmakers complied, Moderna questioned the recommendation as a “hassle” that slowed development, one of the sources told Reuters. Jordan said the company preferred to defer all decisions about monitoring to patients’ physicians but that the company ultimately agreed to some monitoring.
The Trump administration’s “Operation Warp Speed” vaccine program is run by HHS in partnership with other agencies. It is led by Moncef Slaoui, a former GlaxoSmithKline executive who more recently served on Moderna’s board of directors. He stepped down in May to run the government’s COVID-19 vaccine project.”
Moderna outsourced the handling of data collection to the contract research firm PPD Inc. At one meeting set up with the leading companies and government officials, Moderna did not allow PPD to share details of the trial plans, as other companies had done, the sources said. PPD did not respond to request for comment.
The U.S. is a mess, friends. COVID and hacks. And he has power for 33 more days.
17.3 million cases.
In the last week alone, 1 out of every 220 Americans was diagnosed with the coronavirus — an astronomically large portion of the population to be sick at the same time, Axios’ Dani Alberti and Sam Baker write.
- About 1 in 20 have been diagnosed since the pandemic began.
Why it matters: The new infections will translate into large numbers of hospitalizations, and eventually deaths, in the coming weeks.
- It also means the rest of us have a decent chance of interacting with someone who is infected, anywhere we go.
5:50 pm Mountain Time
[by Emily Graffeo]
- Moderna slumped as much as 6.2% on Friday as investors sold off on encouraging news regarding the company’s coronavirus vaccine.
- A panel of Food and Drug Administration experts recommended the vaccine be approved for emergency use on Thursday, a key step that will set the shot up for distribution in the United States as soon as next week.
- Investors are likely taking profits from the stocks 600% year-to-date rally. Shares of Moderna traded around $137 Friday morning.
by MacKenzie Sigalos
In February, Health and Human Services Secretary Alex Azar invoked the Public Readiness and Emergency Preparedness Act. The 2005 law empowers the HHS secretary to provide legal protection to companies making or distributing critical medical supplies, such as vaccines and treatments, unless there’s “willful misconduct” by the company. The protection lasts until 2024.
[by Giacomo Tognini]
Three men have become billionaires in 2020 thanks to Moderna’s stunning rise, with the stock up more than 600% since the beginning of January. Stephane Bancel, 47, joined the company as its CEO in 2011 — one year after its founding — and owns a 7% stake along with a sizable chunk of stock options, giving him an estimated net worth of $4.5 billion. Springer and Langer were both founding investors in the firm and have never sold a share, according to Securities and Exchange Commission filings. Springer owns a 3.5% stake in Moderna, part of a $2.2 billion fortune (down from $2.6 billion on December 8); Langer owns 3%, part of his estimated $1.7 billion net worth (down from $2 billion 10 days ago).
Analysts expect Moderna to post $800 million in sales in 2020 thanks in part to government funding for its Covid-19 vaccine program, up from $60.2 million last year. That could balloon to as much as $10 billion revenue in 2021 as the vaccine is rolled out across the globe. Moderna shares are expected to remain volatile in the near future as investors have already priced in the anticipated FDA approval and will now look to the company’s profitability beyond its Covid-19 vaccine. “The approval is an important positive, but it was widely expected already,” says Michael Yee, an analyst at investment bank Jefferies.
[by Tom Dreisbach/10.4.2020]
From a relative unknown, to a key player in the vaccine race
Modern launched in 2010 with a headquarters based in Cambridge, Mass., focused on using a technology called messenger RNA (or mRNA) to develop vaccines and therapeutics. The mRNA technology has been widely considered innovative, but remains largely unproven.
The company has never brought a product to market.
In early January, Moderna was trading for under $20 per share, and was valued at around six billion dollars.
Then Moderna announced that it had started collaborating on a coronavirus vaccine with scientists from the National Institute of Allergy and Infectious Diseases, which is led by Dr. Anthony Fauci.
By April, the government had committed half a billion dollars to the Moderna vaccine project as part of Operation Warp Speed.
Since then, the company’s stock price has exploded. Press releases suggesting positive news from the scientific trials, or announcing additional commitments of taxpayer funding sent the share price to a peak of around $95, before dropping to between $60-$70 in recent months. The company is now valued at around $25 billion.
On April 12, 1955, the day the Salk vaccine was declared “safe, effective and potent,” legendary CBS newsman Edward R. Morrow interviewed its creator and asked who owned the patent. “Well, the people, I would say,” said Salk in light of the millions of charitable donations raised by the March of Dimes that funded the vaccine’s research and field testing. “There is no patent. Could you patent the sun?”