The coverage of AstraZeneca’s fumbles, she said, feels “alarmist.”
“People do not want to take the vaccine in Europe now, and if that’s because of misinformation, then the pandemic’s going to continue to remain very active globally, which means everybody is vulnerable,” Borio said.
It’s understandable why people might be confused about the AstraZeneca vaccine.
If one read only the headlines over the past few weeks, it might be possible to believe the vaccine was a cause — rather than correlation — of people developing a rare blood-clotting condition called cerebral venous sinus thrombosis.
Over the past few weeks, a number of European nations suspended use of the vaccine as reports of the condition surfaced, even though at the time the number of thrombosis cases among the vaccinated didn’t appear to be higher than in the general population.
AstraZeneca hasn’t exactly helped to alleviate concerns.
The company’s fumbled approach to releasing data about the vaccine and its involvement with a Maryland-based manufacturer that didn’t meet regulatory standards has only served to heighten frustration around the vaccine and its potential rollout in the United States. The company hasn’t yet applied to the FDA for emergency use approval, but it is expected to do so in the next few weeks.
The plot seemed to thicken yesterday.
Medical regulators in Britain and the European Union said it’s plausible AstraZeneca’s vaccine is causing the blood-clotting condition in a small number of those vaccinated. Some new data indicates the occurrence of thrombosis is slightly higher among the vaccinated — although the event is still extremely rare.
“The European Medicines Agency, the European Union’s regulator, said it is investigating at least 44 cases of the rare brain clots and at least 14 deaths among about 9.2 million vaccinations in 30 European countries,” The Post’s Loveday Morris reported this week.
“So far, most of the cases reported have occurred in women under 60, the regulator said, but it said it still has been unable to work out if particular groups were more at risk than others.”
People under age 30 are being offered an alternative vaccine to the AstraZeneca vaccine because of the new evidence, the BBC reported.
“Our conclusion is that these clotting disorders are very rare side effects of the vaccine,” said Sabine Straus, chair of the EMA assessment committee.
There are two important things to keep in mind when assessing vaccine safety.
First, just because a small number of people become ill after getting a vaccine doesn’t necessarily mean the vaccine caused it. The key here is to consider whether the instances of a particular illness in the vaccinated population are higher than in the general, unvaccinated population.
Up until this week, regulators had indicated the cases of thrombosis weren’t higher for the vaccinated.
But now cases have accumulated to the point at which about 4.6 people developed thrombosis for every 1 million shots. That rate is higher than expected over a short time period, Loveday writes.
“The brain clots normally affect around five people per 1 million over the course of a full year, according to Johns Hopkins,” she writes. “The level for those receiving the Pfizer vaccine — which is more widely used in Europe than AstraZeneca’s — has been 0.2 per million following vaccination, and Moderna’s vaccine, which has seen limited distribution in Europe, is zero, the EMA said.”
The new data signals a “safety concern” but doesn’t necessarily mean the vaccine isn’t safe for most people, said Jesse Goodman, professor of medicine and infectious diseases at Georgetown University. He said more complete data is needed before withholding the vaccine from certain populations, such as young women, who seem most affected by thrombosis.
It’s also important to keep relative risk in mind.
For example, even if regulators concluded thrombosis is a very rare side effect of the AstraZeneca vaccine, it could still make sense for people to take the vaccine because the risk of dying from the coronavirus is greater.
For example, the coronavirus case fatality rate for people between ages 60 and 69 is around 2 percent to 3.5 percent. The risk grows exponentially for older age groups. People older than 80 appear to have a case fatality rate of between 13 percent and 20 percent.
“It’s complicated to balance risk and benefit when individuals make decisions,” Goodman said. “The risk of being affected by and dying from covid is higher than the risk from this vaccine.”
The next question is whether AstraZeneca will seek approval for its vaccine to be used in the U.S.
The company hasn’t indicated it’s pulling back from seeking emergency use authorization from the FDA. But if and when it does file for EUA, how regulators respond will have a huge impact on how the world views the vaccine and its safety.
And one other thing: The U.S. government has ordered 300 million doses from AstraZeneca. But it has also purchased or contracted to buy 1 billion coronavirus vaccine doses from other manufacturers. That’s more than enough vaccine to immunize all American adults without needing AstraZeneca’s product.
Ahh, oof and ouch
AHH: More than a half-million Americans have signed up for Obamacare plans during the extended enrollment period.
Some 528,000 people signed up for Affordable Care Act health plans during the first six weeks of an unprecedented extra enrollment window opened by the Biden administration to expand coverage amid the pandemic, The Post’s Amy Goldstein reports.
The enrollees who signed up between Feb. 15, when the marketplaces reopened, and March 31 include a higher proportion of Black Americans and a slightly higher proportion of people living close to the federal poverty line than during the regular open enrollment periods the past two years, according to data from the the Centers for Medicare and Medicaid Services.
Still, the new enrollees represent just a fraction of the population that typically signs up during the regular, year-end enrollment period. Last year, 8.2 million people signed up for coverage.
The Biden administration still cheered the sign-ups: “Access to quality, affordable health care is essential — especially as we tackle the covid-19 pandemic and its aftermath,” Health and Human Services Secretary Xavier Becerra said in a statement.
OOF: Clauses in U.S. vaccine contracts could make it harder to donate doses.
The contracts the Trump administration signed with vaccine manufacturers Pfizer, Moderna, AstraZeneca and Janssen all include language stating: “The Government may not use, or authorize the use of, any products or materials provided under this Project Agreement, unless such use occurs in the United States’ or U.S. territories,” Vanity Fair’s Katherine Eban reports.
The clauses are designed to ensure liability protection, but they could also make it harder for the United States to donate surplus doses.
A Defense Department spokesperson told Vanity Fair: “DoD did attempt to negotiate terms that would allow the use of vaccine doses outside the U.S., but in some cases, the vaccine manufacturers refused.”
The U.S. is lagging far behind other wealthy countries including China and Russia in donating vaccine doses to poorer countries through the global vaccine effort Covax.
Tom Bollyky, director of the global health program at the Council on Foreign Relations, argues the U.S. may still be able to work with companies that participated in Operation Warp Speed to donate vaccine doses:
OUCH: The University of Virginia School of Medicine suspended a student for questioning “microaggressions.”
Kieran Bhattacharya is suing the school, alleging it violated his First Amendment rights after he was suspended from his medical school program. The case stems from a panel discussion on microaggressions that Bhattacharya attended in October 2018, during which he questioned a speaker about her definition of microaggressions and expressed skepticism about the concept.
“Is it a requirement, to be a victim of microaggression, that you are a member of a marginalized group?” Bhattacharya asked presenter Beverly Cowell Adams, an assistant dean. Bhattacharya then clashed with Adams and another speaker for about five minutes over the definition of microaggressions and whether the concept was supported by empirical research, according to court documents.
Following the panel, an assistant professor who helped organize the event filed a complaint about Bhattacharya’s professionalism, sparking a disciplinary process that led to a recommendation that Bhattacharya receive professional counseling, followed by his suspension from the program. The university dismissed Bhattacharya for “aggressive and inappropriate interactions in multiple situations.” Bhattacharya contends that the decision was retaliatory.
More on Obamacare
Democrats are eager to extend ACA subsidies before the midterm elections.
Congress dramatically expanded Obamacare subsidies in the recent coronavirus relief plan, ensuring that people who make less than 150 percent of the poverty line will not have to pay anything for premiums and that others will pay no more than 8.5 percent of their income. But this expansion only lasts for 2021 and 2022.
“Once people start getting these increased premium subsidies, taking them away would mean significant premium increases, which would hit right at the same time as the midterm elections,” Larry Levitt, a senior vice president at the Kaiser Family Foundation, told Roll Call. “It would be terrible both politically and practically.”
Sen. Tim Kaine (D-Va.) said Republicans might be pressured to go along with a stand-alone bill extending the subsidies to improve the affordability of health care. But Republicans uniformly opposed the relief bill and may bank on the idea that, if premiums go up, it will be blamed on the party in power.
The provisions could also make their way into an infrastructure bill that the Biden administration plans to propose this year, although the White House has not said what health-care provisions will be in that package.
The Biden administration is pushing to protect hard-won gains amid an uptick in cases.
“For the first two months, all the coronavirus numbers broke in the Biden administration’s favor,” The Post’s Dan Diamond and Fenit Nirappil report. “More than 100 million Americans have gotten at least one shot of vaccine and more than 200 million doses have been sent to states, a dramatic acceleration of the bumpy vaccine operation it inherited. Virus-related cases and deaths, which peaked in January, have fallen by about two-thirds since President Biden’s inauguration.”
But now infection rates are climbing. Most experts say that the accelerating pace of vaccinations makes it unlikely that the United States will experience a “fourth wave,” but the trend has caused alarm and increased urgency to vaccinate people as quickly as possible.
On Wednesday, Rochelle Walensky, director of the Centers for Disease Control and Prevention, said that the variant known as B.1.1.7 is the most common lineage circulating in the United States, accounting for about 27 percent of cases. The variant, which was first identified in the United Kingdom, is more infectious and may be more deadly than the most common strain that the United States previously faced.
The uptick in infections puts the Biden administration in a politically tricky position. Officials are trying to articulate a nuanced message: urging optimism at the same time they call for greater caution. But many states are pushing ahead with reopening plans and lifting public health restrictions. Alabama Gov. Kay Ivey (R) signed a health order that will allow the state’s mask mandate to expire tomorrow.