Pfizer’s and Moderna’s news galvanized the public health community.
Most epidemiologists and scientists were expecting the vaccines would be between 50 percent and 70 percent effective. Evidence that the vaccines protect 9 out of every 10 people is far better than many had hoped for, said Bob Wachter, chair of the department of medicine at the University of California at San Francisco.
“Everyone I know is incredibly surprised and pleased,” Wachter told me.
Not even the best pediatric vaccines are more than 90 percent effective. And for the coronavirus vaccine, the FDA had set the bar much lower, saying any shot must be at least 50 percent effective.
“I describe myself as a realist, but I’m fundamentally a cautious optimist,” Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told my colleague Carolyn Y. Johnson. “I felt we’d likely get something less than this. … I said certainly a 90-plus percent effective vaccine is possible, but I wasn’t counting on it.”
Even the administration’s harshest critics say the vaccine effort has been impressive.
Operation Warp Speed, the government’s $10 billion vaccine-development initiative, has emerged as a bright spot in the Trump administration’s otherwise tainted response to the pandemic.
“I have to sort of swallow when I say it, but I really do think on this one they got it right,” Wachter said.
Trump, being Trump, readily took credit on Twitter for the successes:
Moderna received $1 billion from OWS for developing and testing its vaccine, and another $1.5 billion for doses once the vaccine is approved. NIAID, the agency Fauci leads, worked closely with the company’s researchers throughout the process.
While Pfizer didn’t get funding from OWS for development, it does have an advance agreement from the federal government for purchasing doses — a promise that gave the company more confidence to invest heavily in the project.
Pfizer is expected to apply to the FDA for emergency use next week.
And Moderna is expected to follow suit in late November or early December. Once the FDA grants emergency use authorization for a vaccine, the shots will be able to be distributed to certain high-risk groups, including front-line medical workers.
Here’s the sequence of what to expect, from Carolyn and Aaron Steckelberg:
Where and to whom the initial round of shots are distributed will depend largely on the FDA advisory panel, which probably will recommend health-care workers get vaccinated first. After that, they may recommend giving high priority to workers in essential industries, people with certain medical conditions, and people age 65 and older.
Panel members will make their recommendations after the FDA gives the green light to a vaccine and after looking at clinical trial data on side effects and how different categories of people responded. The recommendations will give states a guide as they distribute the first vaccines.
Storing the vaccine doses could be a challenge.
That’s particularly true for the Pfizer vaccine, which must be kept very cold.
“The Moderna vaccine is stored frozen at minus-20 degrees Celsius, but it keeps for a month at refrigerator temperatures,” Carolyn and Aaron write. “This could make it easier to distribute to pharmacies and to rural areas that don’t have specialized freezers.”
Pfizer’s vaccine must be kept at minus-70 degrees Celsius, they add, noting that the company has created its own GPS-tracked coolers filled with dry ice to distribute it.
“Each vial of the Pfizer vaccine holds five doses when diluted,” Carolyn and Aaron write. “Once thawed, the undiluted vial can be kept in a refrigerator for only five days. A diluted vial can be kept for only six hours before it must be discarded.”
The vaccines will be the first to use messenger RNA technology on humans.
If cleared by the FDA, Pfizer and Moderna’s coronavirus vaccines will be the first vaccines approved for humans that use a virus’s own genetic code to protect the body from it.
“It is different from more traditional vaccines, which often use a weakened or dead version of a virus, or a laboratory-generated protein,” my colleagues explain. “Both vaccines use a snippet of the virus’s genetic code to instruct cells to build the spike protein on the surface of the coronavirus, teaching the immune system to recognize the real thing.”
Ahh, oof and ouch
AHH: Gun advocates and suicide prevention experts have joined to stop self-inflicted gun deaths.
“Gun shows across the country had started giving suicide-prevention booths space at their events before the coronavirus appeared. Now, the National Shooting Sports Foundation, a trade association for the firearms industry, carries a suicide-prevention video on the home page of its website, and invites suicide experts to give talks at online events,” the New York Times’s Roni Caryn Rabin reports.
The effort to promote suicide awareness among gun owners, their friends and families, and retailers comes as experts are bracing for a rise in suicides driven by increased anxiety and depression during the coronavirus pandemic, as well as by a surge in gun sales since March.
“Gun violence kills about 40,000 Americans each year, but while public attention has focused on mass shootings, murders and accidental gun deaths, these account for little more than one-third of the nation’s firearms fatalities. The majority of gun deaths are suicides — and just over half of suicides involve guns,” Rabin reports.
While some suicide prevention advocates have expressed unease about working with groups such as the National Rifle Association or the National Shooting Sports Foundation, which oppose many of the gun safety measures that public health experts support, others, such as Kyleanne Hunter, the former vice president of programs for the anti-gun violence group Brady, say it’s vital to work with gun owners.
“We’re not going to crack this nut if we isolate gun owners from the conversation,” Hunter told the Times.
OOF: Major medical groups have called on Trump to share coronavirus data with Biden’s transition team.
CEOs from the American Hospital Association, the American Medical Association and the American Nurses Association wrote to Trump urging him to “work closely with the Biden transition team to share all critical information related to COVID-19.” The groups called on the president to provide data to the incoming administration about the Strategic National Stockpile, Operation Warp Speed and plans for disseminating therapeutics and vaccines.
“Real-time data and information on the supply of therapeutics, testing supplies, personal protective equipment, ventilators, hospital bed capacity and workforce availability to plan for further deployment of the nation’s assets needs to be shared to save countless lives,” the health-care leaders wrote.
As Trump continues to falsely insist that he won the election, the administration has not yet signed the paperwork to begin the transition process, which will allow Biden’s team to gain access to federal agencies, funding and classified briefings.
The health-care groups join a chorus of voices pressuring the Trump administration to engage in the transition process. Fauci said Monday that the refusal to engage with the Biden team could slow the rollout of vaccines. Fauci, who has been through multiple transitions during his 36 years in government, compared the transition process to “passing a baton in a race.” “You don’t want to stop,” he said.
OUCH: Grassley tested positive for the coronavirus.
“Iowa Republican Sen. Charles E. Grassley, the president pro tempore of the Senate, which makes him the third in line of succession to the presidency, revealed Tuesday that he has contracted the coronavirus,” Colby Itkowitz and Mike DeBonis report.
Grassley, 87, tweeted that he was “feeling good” and would keep working from home while isolating.
Grassley opened the Senate on Monday afternoon, and while he spoke about the need for Americans to wear masks, he did not wear one during his remarks.
The news comes as senators have fiercely clashed over whether senators should wear masks in the chamber. Sen. Sherrod Brown (D-Ohio) asked Sen. Dan Sullivan (R-Alaska) to “please wear a mask” when presiding over the Senate.
“I don’t wear a mask when I’m speaking, like most senators. I don’t need your instruction,” Sullivan shot back.
Later, Sen. Ted Cruz (R-Tex.) called Brown’s request “idiotic” in a tweet.
Grassley is the sixth GOP senator to test positive for the virus. Two Democratic senators, Bob Casey (Pa.) and Tim Kaine (Va.) have said they tested positive for antibodies, indicating that they were previously exposed. Meanwhile, at least three House members tested positive for the virus this month, including Rep. Don Young (R-Alaska), the longest-serving member of the House.
More in coronavirus
- The number of Americans who say they are willing to get a coronavirus vaccine rose to 58 percent from a low of 50 percent, according to a Gallup poll conducted before Pfizer/BioNTech and Moderna announced promising early results in their vaccine trials.
- The Centers for Disease Control and Prevention quietly removed guidance from its website that advocated school reopenings and downplayed the risk that children could transmit the coronavirus. A CDC spokesperson said that some of the content was “outdated,” the Hill’s Jessie Hellman reports.
- A Justice Department inspector general report found that a federal prison in Oakdale, La., failed to isolate some inmates who tested positive for coronavirus for up to six days, ABC News’s Alexander Mallin reports.
- A South Dakota emergency room nurse described in a viral tweet her experience treating patients who denied the existence of the coronavirus pandemic up until their deaths, Paulina Villegas reports.
Elsewhere in health care
Amazon opened up an online pharmacy, rattling the drugstore industry.
The move, although long expected, sent stocks in drugstore chains plummeting, Jay Greene reports. “Shares in both CVS and Walgreens Boots Alliance slid about 9 percent in midday trading. Rite Aid’s stock fell more than 15 percent,” Jay writes.
The move into the industry has been anticipated since Amazon acquired online pharmacy PillPack for $753 million two years ago. In making the move into pharmacy sales, Amazon is entering a big industry.
“Prescription drug sales will approach $360 billion this year, according to a forecast from the Centers for Medicare & Medicaid Services, an agency within the Department of Health and Human Services,” Jay writes. “With the ongoing coronavirus pandemic, Amazon Pharmacy hopes to take advantage of the burgeoning interest in shopping from home.”
The online pharmacy will sell commonly prescribed medications, including insulin and inhalers, and will offer Amazon Prime members two-day free shipping. The company said it will not ship opioids or other controlled substances.
Amazon says it will accept most insurance but will also offer price discounts to Prime members who don’t have insurance. Health economist Craig Garthwaite told the Associated Press that he expects Amazon may be competitive on the pricing of generic drugs and could provide an easy way for patients to shop by price.
Pain patients struggle to find prescription opioids in New York after a tax drove out many suppliers.
The excise tax on many opioids passed in July 2019 “was touted as a way to punish major drugmakers for their role in the opioid epidemic and generate funding for treatment programs,” Kaiser Health News’s Anastassia Gliadkovskaya reports. “But to avoid paying, scores of manufacturers and wholesalers stopped selling opioids in New York. Instead of the anticipated $100 million, the tax brought in less than $30 million in revenue, two lawmakers said in interviews.”
The tax, which hits the company that makes the first point of sale in New York, often ends up affecting wholesalers selling to pharmacies rather than drugmakers.
“Indeed, nine independent pharmacies told KHN that when they can get opioids they are more expensive now. They have little choice but to eat the cost, drop certain prescriptions or pass the expense along,” Gliadkovskaya writes.
The result is that many patients are unable to get prescribed pain medications. Some pharmacists worry that these patients may be more likely to turn to street drugs.