Wednesday, March 24, 2021 | Kaiser Health News

Tom Smith

AstraZeneca Will Release More Vaccine Data As Health Officials Detail Worries After members of a U.S. safety board questioned AstraZeneca’s new covid vaccine trial data, Dr. Anthony Fauci said the drug maker needs to “straighten” out its issues. Worries deepen that trust in the vaccine has taken a hit. Axios: […]

AstraZeneca Will Release More Vaccine Data As Health Officials Detail Worries

After members of a U.S. safety board questioned AstraZeneca’s new covid vaccine trial data, Dr. Anthony Fauci said the drug maker needs to “straighten” out its issues. Worries deepen that trust in the vaccine has taken a hit.


Axios:
AstraZeneca Commits To More Vaccine Data After Concerns From NIH 


AstraZeneca acknowledged on Tuesday morning that a press release about its U.S. coronavirus vaccine trial was based on data through Feb. 17, and promised to release more complete results that are “consistent with” the interim data within the next 48 hours. The National Institute of Allergy and Infectious Diseases (NIAID) released an unusual statement early Tuesday expressing concerns that AstraZeneca’s release may have used “outdated information” that “may have provided an incomplete view of the efficacy data.” (3/23)


The Wall Street Journal:
U.S. Health Officials Raise Concerns Over AstraZeneca Vaccine Data


AstraZeneca said it would update and reissue later this week efficacy data from human trials of its Covid-19 vaccine after U.S. officials took the rare move of publicly questioning their accuracy—the latest misstep by the British drug giant as it struggles to get its shot into American arms. … The day before, AstraZeneca released interim data from a large-scale U.S. trial that it said found its Covid-19 vaccine to be 79% effective in preventing symptomatic disease. (Strasburg, Burton and Walker, 3/23)


Politico:
Fauci: AstraZeneca Needs To ‘Straighten Out’ Vaccine Data


The DSMB “wrote a rather harsh note” to AstraZeneca with NIAID Director — and Biden medical adviser — Anthony Fauci copied in, he told POLITICO. “The issue that the DSMB had is straightforward and very simple: The DSMB had data that they know the company had. When they saw the press release, they said, ‘wait a minute — the data in the press release do not reflect the most recent data that we know you have,'” he said. Fauci also discussed the issue during an appearance Tuesday morning on “Good Morning America.” The data board felt the data released by AstraZeneca “might, in fact, be misleading a bit, and wanted them to straighten it out,” he said. (Owermohle, 3/23)

Also —


Stat:
Mishaps, Miscommunications Overshadow AstraZeneca’s Covid Vaccine


Yet again, AstraZeneca is in a crisis of its own making. The latest in the drug manufacturer’s long string of mishaps and miscommunications came Tuesday, when top federal health officials accused the company of highlighting in a press release overly positive data about the efficacy of its coronavirus vaccine. It came after widely publicized snafus like administering incorrect doses during clinical trials and keeping U.S. regulators in the dark after pausing a trial entirely due to safety concerns. (Joseph and Facher, 3/23)


Stat:
Swashbuckling CEO Flies AstraZeneca Into Turbulence 


It took eight years, a failed hostile takeover, and a sweeping scientific turnaround for AstraZeneca CEO Pascal Soriot to become one of the drug industry’s leading lights. Now, after 11 bumbling months of Covid-19 vaccine development, the French-born executive finds himself at the center of a multinational credibility crisis, moving from scandal to scandal as his rivals bask in global acclaim. (Herper and Garde, 3/23)


The Wall Street Journal:
AstraZeneca Covid-19 Vaccine Dispute Shines Spotlight On Data Monitoring Boards


The dispute over AstraZeneca’s Covid-19 vaccine trial has exposed the crucial role played by independent expert panels in behind-the-scenes oversight of clinical pharmaceutical trials. The panels, called data and safety monitoring boards, are typically composed of medical experts and scientists such as biostaticians, clinicians and epidemiologists. They are tasked with safeguarding the safety of study volunteers and the scientific integrity of the studies, said Joseph Ross, professor of medicine and of public health at Yale University School of Medicine. (Walker, 3/23)

Johnson & Johnson Pressured To Improve Covid Vaccine Supply

Covid vaccine maker Johnson & Johnson is given emergency authority for a pharma plant in Indiana to boost production of its single-dose covid vaccine, even as its supplies falter and the company is under pressure to deliver more shots.


Politico:
New Signs J&J May Not Be Able To Hit Vaccine Delivery Goal


The supply situation has frustrated administration officials trying to deliver on President Joe Biden’s directive to offer vaccines to all U.S. adults by May. The White House was counting on the single-dose J&J shot to reach underserved populations and accelerate the country’s return to normal. POLITICO on Monday reported that the administration is increasingly concerned the company won’t make its target. White House officials told governors in a private call Tuesday that the federal retail pharmacy program is slated to receive 1.5 million J&J shots next week, according to one source on the call. States are set to receive around 2 million doses, according to three individuals with knowledge of the administration’s distribution plans. (Roubein and Banco, 3/23)


Roll Call:
Johnson & Johnson Under Pressure To Deliver Promised Vaccine Doses


Johnson & Johnson is under pressure to deliver its promised 20 million vaccine doses by next week, as several state public health officials indicate they are receiving few or no shots this week and have no idea how much they’ll get later. The uncertainty comes at a time when the demand for vaccines continues to overwhelm supply, a weary country braces for the spread of viral variants and hundreds of people die from COVID-19 each day. It raises questions about how successful the company was in meeting a central goal of the massive U.S. investment in vaccine development: to manufacture sufficient supplies of shots before they were proven effective in order to hit the ground running. (Kopp, 3/23)


Axios:
U.S. Approves Johnson & Johnson COVID Vaccine Plant 


The FDA issued an Emergency Use Authorization for a Catalent Pharma plant in Bloomington, Indiana, allowing it to produce and ship doses of Johnson & Johnson’s coronavirus vaccine, the company announced Tuesday. The plant will help J&J increase COVID vaccine shipments this spring and eventually fulfill the 200 million doses the pharmaceutical company agreed to deliver to the United States, according to Bloomberg. (Knutson, 3/23)

Vaccine Production Nearly Triples In March

Pfizer, its partner BioNTech and Moderna have scaled up production lines and are making certain raw materials themselves.


The Wall Street Journal:
Covid-19 Vaccine Manufacturing In U.S. Races Ahead 


After a slow start, Pfizer Inc., its partner BioNTech SE and Moderna Inc. have raised output by gaining experience, scaling up production lines and taking other steps like making certain raw materials on their own. Pfizer figured out how to stretch scarce supplies of special filters needed for the vaccine production process by recycling them. Moderna shortened the time it needed to inspect and package newly manufactured vials of its vaccine. (Loftus, 3/21)


Axios:
Vaccine Manufacturing Output Expected To Have Tripled From February To March 


Vaccine makers have drastically increased their manufacturing capacity, and output of the three vaccines authorized in the U.S. is expected to in March be nearly triple the amount produced in February, the Wall Street Journal reports. The faster shots are made, the faster they can be put in arms, and the sooner life can begin to approach normal. (Owens, 3/22)

Also —


The Washington Post:
Becerra Says Government Must Reach People Where They Are To Surmount Vaccine Inequities


Health and Human Services Secretary Xavier Becerra said the federal campaign to vaccinate Americans against the coronavirus must “reach people where they are,” bringing vaccine-filled syringes into farm fields and onto construction sites to ease profound racial and ethnic disparities in who has been receiving the protective shots. “We’re not going to say, ‘Now, just come get your vaccine,’ which is a very different model than we’ve done in the past,” Becerra said in his first interview since being sworn in as the nation’s top health official late last week. Too often, he said, Black and Latino Americans in low-wage jobs believe “their government thinks they are invisible.” (Goldstein, 3/23)


Health News Florida:
Vice President Visits Jacksonville, Emphasizes Importance Of Getting Vaccinated 


Vice President Kamala Harris on Monday visited Jacksonville, where she visited the city’s federally run COVID-19 vaccine distrbution site and touted the benefits of the recently passed $1.9 trillion American Rescue Plan with a visit to a local food bank. “We’re going to be here visiting a vaccination site saying, ‘Look everybody … when it’s your turn go and get vaccinated,’ and that’s the message of the day and that should be the message everyday, including reminding folks to wear a mask and wash their hands and social distance,” the vice president said. (Bortzfield, 3/23)


Columbus Ledger-Enquirer:
CDC COVID Vaccine Data Issue Uncovered In GA, Other States 


Health officials are unable to accurately track the number of vaccines administered in several states because of a reporting issue between pharmacies and state databases, CDC officials confirmed to McClatchy. The CDC could not specify the states affected or when the issue began, only that there was a reporting issue among a “small subset” of shots. Federal officials say they are working with vendors and pharmacy partners to rectify the issue “as soon as possible.” (Wooten, 3/23)

Overseas US Military Finding It Hard To Get Covid Vaccines

As states from Texas to Georgia are rapidly expanding their covid vaccine eligibility to all residents over 16, military forces stationed overseas are reportedly frustrated at the Department of Defense’s vaccine roll out.


Roll Call:
Americans At Military Bases Overseas Struggle To Get COVID-19 Vaccine


Emilee Seger watched as her home state of Ohio announced that it would open COVID-19 vaccinations to all adults by the end of the month. If she were home, it would have been cause for celebration. But Seger, who lives more than 4,000 miles away at Ramstein Air Base in Germany, felt abandoned. On base, vaccinations are only available to the highest-priority groups, and the supply is so limited that some second doses have been canceled. (Satter, 3/24)


The New York Times:
Texas, Indiana And Georgia Are Making All Adults Eligible For Covid-19 Vaccination


Texas, Indiana and Georgia announced Tuesday that residents 16 years and older will be eligible for Covid-19 vaccinations starting Thursday for Georgia residents, Monday for Texans and on March 31 for Indianans. They joining a growing list of states that plan to broaden vaccine eligibility to all adults ahead of a May 1 deadline set by President Biden. “With every dose, Texas gets closer to normal and protects more lives from COVID-19 hospitalization and death,” the state’s health department said in a Twitter post. (3/24)


The Oregonian:
COVID-19 Vaccine Doses Headed To Oregon Pharmacies Has Nearly Doubled In Last Two Weeks 


The number of COVID-19 vaccine doses headed to Oregon pharmacies has grown dramatically over the last several weeks as the federal government has continued to ramp up its pharmacy program. Oregon pharmacies will receive more than 44,000 COVID-19 vaccine doses this week through the Federal Retail Pharmacy Program. Two weeks ago, pharmacies within the state were receiving just 24,000 doses per week. (Goldberg, 3/23)


North Carolina Health News:
Daunting Logistics To Vaccinate Homebound Folks 


A few days ago, Jay Smith and his wife, Yolanda, loaded up his wheelchair in the car and went down to the state Division of Motor Vehicles office near his Raleigh home to surrender his license. “You can’t do it by mail, you have to go there,” Jay Smith said. “It’s like 3 months to get an appointment.” Smith, 57, was diagnosed with amyotrophic lateral sclerosis, known more commonly as ALS or Lou Gehrig’s disease, in December and he’s had rapid loss of ability. By the time his appointment rolled around, he could barely transfer from his car to a wheelchair to go into the building. (Hoban, 3/24)


USA Today:
Many Won’t Travel, Dine Out Until Herd Immunity Arrives


A growing share of Americans would feel safe resuming activities like dining out or flying within a few weeks of their second dose of COVID-19 vaccine, but about 25% to 30% would wait until the nation reaches herd immunity, according to a Harris Poll survey for USA TODAY. Their attitudes bode well for what’s expected to be a historically robust recovery from the coronavirus recession. But the sizeable share of people who prefer to wait until at least 70% of the population is immune could mean a less roaring launch to the rebound as some activity shifts to late summer and fall from midyear. (Davidson, 3/24)

In updates from Maryland —


The Baltimore Sun:
Maryland COVID Vaccine Eligibility Expands Next Week To Include All With CDC Underlying Conditions, Disabilities 


Starting next week, people with a range of underlying medical conditions identified by the U.S. Centers for Disease Control and Prevention as risk factors for severe cases of the coronavirus will be eligible for a COVID-19 vaccination appointments, state officials said Tuesday. Currently, cancer patients, people with end-stage renal disease on hemodialysis, sickle-cell disease patients, people with Type 1 or Type 2 diabetes, people with chronic obstructive pulmonary disease (COPD), and solid organ transplant recipients qualify for vaccines in the state, though they have to be receiving inpatient or outpatient treatment in a hospital setting. (Miller, 3/23)


The Baltimore Sun:
Maryland To Double Mass COVID Vaccination Sites As Hogan, Health Officials Warn Of Threat Of Virus Variants 


Maryland Gov. Larry Hogan announced Tuesday the state would double the number of state-run mass COVID-19 vaccination clinics by mid-April, while offering a new warning about the spread of coronavirus variants. As he unveiled plans to open mass immunization sites in six of the state’s most populous counties, the Republican governor rebranded the inoculation effort “as a race between the vaccines and the variants.” (Mann and Stole, 3/23)


The Baltimore Sun:
Maryland’s Emergency Contracts For COVID Vaccine Rollout To Get Public Review 


A set of emergency contracts signed by the Hogan administration to help the state with its COVID-19 vaccine rollout will get their first official review Wednesday, providing a window into the millions in public spending done quickly and in private to combat the pandemic. The Maryland Board of Public Works is expected to consider the contracts, one with New York-based consulting firm Ernst & Young and the other with Bethesda-based Digital Management. Together, they could reach a combined value of $46 million. (Miller and Cohn, 3/23)

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