Covering COVID-19 is a daily Poynter briefing of story ideas about the coronavirus and other timely topics for journalists, written by senior faculty Al Tompkins. Sign up here to have it delivered to your inbox every weekday morning.
The first big question the public will ask is whether any of the 15 million doses of Johnson & Johnson’s vaccine that workers ruined in a manufacturing mistake made it to vaccination lines. The New York Times, which broke this story late Wednesday, says that the mistake does not involve any of the vaccines in the supply chain right now. In other words, the mistake was contained at the factory.
That should be a loud and clear message today; that the safety of vaccines that people are lined up to get is not in question.
All of the doses in the pipeline right now came from Johnson & Johnson’s plant in The Netherlands. The mistake happened at the plant of a subcontractor, Emergent BioSolutions, which is in Baltimore.
Johnson & Johnson hired Emergent BioSolutions to manufacture the active ingredient. Workers at the facility mistakenly mixed ingredients for the Johnson & Johnson vaccine with those of another manufacturer’s shot. Emergent does contract work for both Johnson & Johnson and Moderna.
The Baltimore Sun says the mixup happened a couple of weeks ago, but until now, word did not leak. Johnson & Johnson issued a statement Wednesday night that doesn’t mention the mistake until the third paragraph. When it does get to the issue, it says:
As with the manufacturing of any complex biologic medication or vaccine, the start-up for a new process includes test runs and quality checks to ensure manufacturing is validated and the end product meets our high-quality standards. This approach includes having dedicated specialists on the ground at the companies that are part of our global manufacturing network to support safety and quality.
This quality control process identified one batch of drug substance that did not meet quality standards at Emergent Biosolutions, a site not yet authorized to manufacture drug substance for our COVID-19 vaccine. This batch was never advanced to the filling and finishing stages of our manufacturing process.
This is an example of the rigorous quality control applied to each batch of drug substance. The issue was identified and addressed with Emergent and shared with the United States Food & Drug Administration (FDA).
Emergent was supposed to send its drug substance to Catalent, a New Jersey drug manufacturer, to bottle the vaccine. The FDA approved Catalent’s production role last week, and Emergent had already begun shipping millions of doses to the other firm, people familiar with J&J’s authorization told POLITICO last week. But Catalent cannot release the Emergent doses without the Maryland company’s emergency clearance.
The Johnson & Johnson vaccine is the only one-dose shot approved for use in the United States. Even though this supply interruption is not insignificant, Pfizer and Moderna’s two-shot vaccines are in full production (and Pfizer is even ahead of its production schedule), so it is uncertain right now if any Americans will have their vaccinations delayed. Johnson & Johnson says it expects to meet its goal of producing a billion doses by the end of 2021.
The larger unanswerable question is how will this bad news sit with the already skeptical unvaccinated public?
The good preliminary news about vaccines for teens
There is every reason to believe that before school starts this fall, teenagers will be able to get vaccinated.
Pfizer says it will be ready to hand over the results of its latest field trials involving 12- to 15-year-olds in about a month. It says the tests, so far, show the vaccine is 100% effective. Keep in mind that this is only one month’s worth of data, so it is too early to say how the numbers will hold up over time. The press release says the vaccine was “well-tolerated” by younger people, but we do not know what that means about how they experience side effects.
The Pfizer-BioNTech vaccine has already been authorized for use in the U.S. in people 16 and older.
Pfizer CEO Albert Bourla said in a press release, “We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15.”
The field trial involved 2,260 volunteers. None of the teens involved became infected.
Once the vaccines are approved for teenagers, a stickier question will arise about whether schools will require students to get the COVID-19 vaccine as they already do with other immunizations.
Vaccinating children is crucial to ending the pandemic, public health officials and infectious disease experts say. The nation is unlikely to achieve herd immunity — when enough people in a given community have antibodies against a specific disease — until children can get vaccinated, experts say.
Children make up around 20% of the U.S. population, according to government data. Between 70% and 85% of the U.S. population needs to be vaccinated against Covid to achieve herd immunity, experts say, and some adults may refuse to get the shots.
CNBC also catches us up on the drug trials underway for the other approved vaccines:
More disturbing reports after AstraZeneca vaccinations
Once again, countries are raising concerns about whether the AstraZeneca vaccine is related to serious blood clots in patients who were recently vaccinated. A number of European countries paused the use of the vaccine but then resumed vaccinations. But now, there are new concerns.
German Health Minister Jens Spahn and the 16 state health ministers decided to suspend the routine use of the AstraZeneca vaccine for people under age 60 at an emergency meeting.
Authorities in the cities of Berlin and Munich had earlier decided to limit the use of the vaccine.
People under 60 can still receive the shot, but only “at the discretion of doctors, and after individual risk analysis and thorough explanation,” according to a document seen by the DPA news agency.
Germany’s vaccine regulator piled on 31 more cases of people who developed a “rare” blood clot on the brain after each of these patients received the AstraZeneca vaccine. Nine of the patients died. Only two of the cases involved men. The women were ages 20 to 63. Even so, Germany still considers the vaccine to be safe and effective. There is still no proven link between the vaccine and the clots.
Also this week, Canada paused using the AstraZeneca vaccine on anybody under age 55. Canada also still says it is a safe and effective vaccine.
The AstraZeneca vaccine is an important cornerstone of the globe’s vaccination needs. COVID-19 is now claiming 3,000 European lives a day and cases are rising while vaccinations stalled. Out of 20 million Europeans who have been vaccinated, the possible and still unproven harmful reactions hover around a few dozen. But the doubts have been enough to rattle confidence. The Atlantic notes, “French adults now say they have little or no confidence in the AstraZeneca vaccine; similar poll numbers are turning up in Germany, Italy, and Spain.”
As Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told USA Today, “While it’s easy to scare people, it’s very hard to unscare them.” He added, “It creates the perception that these vaccines are dangerous.”
The AstraZeneca vaccine has not been approved for use in the United States, even though the U.S. is sending doses to Mexico and Canada.
President Biden’s post-pandemic infrastructure plan includes cash rebates for electric vehicles
President Joe Biden says his $2.25 trillion infrastructure plan would not only stimulate a post-pandemic economy, but would also be an attempt to address climate change, beginning with moving the country away from gasoline engines to electric vehicles.
He suggests a direct rebate for people who buy American-made electric cars. CNet points out the instant reward might be more attractive than a tax credit, which is offered now:
Today, buyers can take advantage of a $7,500 federal tax credit for qualifying electric cars and plug-in hybrid vehicles. But they don’t see the reimbursement until they file taxes the following year — and only if they paid more tax than the credit. Direct rebates would make EVs cheaper for all buyers right as they sign on the dotted line. The White House fact sheet didn’t specify how much it targets for each rebate, or if we’ll see a sliding scale like the child tax credit system. It’s also not clear if the rebates would coexist with the $7,500 tax credit, or if this plan would replace the current system.
The Biden plan would also install a half-million charging stations around the country within the next nine years.
Speaking of transportation, the plan includes lots of money to encourage people to use trains and mass transit. The plan calls for:
- $80 billion to repair Amtrak lines
- $85 billion to support freight and passenger trains
- $105 billion to go directly to repairing 24,000 buses, 5,000 rail cars, 200 stations, and thousands of miles of track, signals, and power systems in need of replacement
- Modernizing 20,000 miles of highways
- Repairing 10,000 smaller bridges
- Geting broadband coverage to all Americans
- Retrofitting 2 million homes and businesses to make them more energy efficient
- Replacing 50,000 diesel transit vehicles and electrifying at least 20% of the yellow school bus fleet. The White House says, “These investments will set us on a path to 100% clean buses, while ensuring that the American workforce is trained to operate and maintain this 21st-century infrastructure.”
- Electrifying the federal automotive fleet, including the U.S. Postal Service
- Expanding the construction of affordable homes through grants, tax credits and rental assistance
- $40 billion to rehabilitate public housing. “This funding will address critical life-safety concerns, mitigate imminent hazards to residents, and undertake energy efficiency measures which will significantly reduce ongoing operating expenses,” Biden says. “These improvements will disproportionately benefit women, people of color, and people with disabilities.” Journalists, go find out the condition of public housing in your communities. Don’t just drive through the neighborhoods. Show us how people are living. Take us inside.
- $100 billion to upgrade and build new public schools
- $18 billion to modernize Veterans Affairs hospitals. The White House points out that the average age of private sector hospitals in the U.S. is 11 years, but the average age of VA hospitals is 58 years. Again, journalists would do a big service if we could see their condition with our own eyes.
Biden says he would like to see some congressional action on this by Memorial Day. Senate Republicans called it a “Trojan Horse” that is too expensive.
The COVID-19 crisis in Brazil and why it matters to you
The next few items in today’s newsletter have to do with international COVID-19 issues because, if we have learned something in the last year, it is that a virus knows no borders. We cannot live under some notion that “that’s them, not us.” In a pandemic, we are in this mess together.
So many people are dying from COVID-19 in Brazil that in São Paulo, cemetery workers are burying people at night to keep up. Crematoriums are full. Ambulances with COVID-19 patients wait outside hospitals for a bed to open up. Hospital intensive care units are reaching capacity. Increasingly, the victims are young people who are infected with a fast-spreading variant of the virus that has U.S. officials concerned.
Information from hospital admissions suggests the virus is hitting more younger people, says Raphael Guimarães at Fiocruz. He says there has been a surprising increase in the number of 30 to 59-year-olds needing hospitalization. “It means that the pandemic in Brazil is reaching the younger population,” he says.
The P.1 variant of the virus may be to blame for the high case numbers in Brazil. Studies suggest the variant has mutations that help it evade antibodies from previous infections or from vaccination, and thus may be able to reinfect people who have already been infected.
Brazil now has the second-most deaths of any country in the world, behind only the United States. Only 2% of the population has gotten at least one dose of a COVID-19 vaccine.
The rapid spread of COVID-19 in Brazil is raising alarm in other countries. Chile, which was a world leader in getting people vaccinated, is now imposing strict new lockdowns to cope with what appears to be a new wave of infections. Other South American countries are shunning Brazil for its inability to stem the virus. The Guardian reports:
Argentina, Colombia and Peru banning flights to their Portuguese-speaking neighbor and Venezuela’s leader, Nicolás Maduro, berating his rightwing rival over a calamity that has killed more than 300,000 Brazilians.
“It’s alarming, even distressing, to see the reports out of São Paulo and Rio … and the reckless attitude of the Trumpist Brazilian right and Jair Bolsonaro towards the people of Brazil,” Maduro declared last week as he ordered a 14-day lockdown to counter the more contagious P1 variant at the heart of global fears over Brazil’s unchecked outbreak.
“Brazil now represents a threat to the world. And whose fault is it? Jair Bolsonaro’s,” Maduro proclaimed, jabbing his index finger into the air. “It’s just madness. There’s no name for it.”
France extends lockdown
France just expanded its COVID-19 lockdown, including a nighttime curfew, restrictions on how far people can travel and the closure of nonessential businesses. The expansion begins tomorrow. France24 reports:
“The Covid-19 pandemic is accelerating almost everywhere in France,” Health Minister Olivier Véran said, adding that pressure on the hospital system will continue to increase in coming days.
President Emmanuel Macron has said the measures should not even be described as a lockdown, with the government calling them a “third way” to put a brake on the virus without closing down the country.
The new restrictions are set to last for at least four weeks, which officials hope will be enough time to ease pressure on hospitals while authorities race to get more people vaccinated.
What is ‘right to repair’ and why are 29 states considering legislation to mandate it?
In the pandemic, we all really need our computer and phone stuff to work. When it breaks, it is harder than ever to get it fixed because the stores can only see so many people because of social distancing. You could go to a small repair shop, but they cannot get their hands on the parts or the service manuals they need to fix your stuff.
The problem has become more pronounced in the past decade, as personal devices, appliances and machinery have become increasingly sophisticated. At the same time, brand-name manufacturers have become stingier with spare parts and maintenance information.
The resulting frustration has given new impetus to at least 39 so-called right-to-repair bills in 25 states. The legislation would loosen restrictions on manufacturers’ information and parts and allow small repair shops and handy device owners to do their own fixing.
Manufacturers and distributors of brand-name products are opposed. They say unauthorized repairs are unsafe and compromise security by putting nonstandard components into machines which they say makes them more vulnerable to hacking. Stateline continues:
Supporters of the right-to-repair bills dispute those assertions.
“(If) we can’t get repair manuals, we have to reverse engineer every device,” said Hilary Shohoney, executive director of Free Geek. “We have to break it to repair it. Trying to find one battery for one machine is damn near impossible. We have to group laptops together to create schematic boards ourselves.”
The bills under consideration in many state legislatures would make the schematics and parts publicly available. Many of the bills are modeled on a Massachusetts law that was approved by voters last November, though that measure applies only to automotive repairs. The Massachusetts legislature is considering a bill that would expand the law to also cover electronic equipment.
The Campaign for the Right to Repair has been working on this issue for some time. The group says it helped make it easier for hospitals to repair their ventilators last year. 500 medical repair experts joined in the campaign.
The campaign put together a collection of bills that percolated last year and are moving along now.
Nathan Proctor, director of the Campaign for the Right to Repair, reports:
Right to Repair was introduced or carried over in the legislature in 20 states. Carryovers included California, Massachusetts (House and Senate), Minnesota, Vermont (which added a companion bill in the House), New Hampshire, New York (House and Senate), Illinois, Washington (House and Senate), Georgia, and Hawaii (which added a companion bill on the House side).
I have to say, I think this is one heck of an interesting story topic for you to explore. It transcends personal electronics and business machines and includes even life-saving medical, automotive and agricultural devices.
We’ll be back tomorrow with a new edition of Covering COVID-19. Are you subscribed? Sign up here to get it delivered right to your inbox.