Despite what the drug company itself says, the European Medicines Agency now says blood clots should be listed as “very rare side effects” of AstraZeneca’s COVID-19 vaccine. It is another problem for the vaccine that is the backbone of Europe’s vaccination efforts.
European health authorities investigated 169 cases of patients who got the AstraZeneca vaccine and developed a rare brain blood clot out of 34 million doses administered so far. England’s deputy chief medical officer, Jonathan Van-Tam, said the side effects are “vanishingly rare.”
German news site DW reports, “Of the 31 cases of rare thrombosis reported to Germany’s Paul Ehrlich Institute, it was determined each person had recently received the AstraZeneca vaccine. In nine cases, the outcome was fatal.”
Still, Emer Cooke, the director of the European Medicines Agency, said, “This vaccine has proved to be highly effective.” The World Health Organization is among the voices imploring people to take the AstraZeneca shots.
But a number of European countries stalled their vaccination programs because of concerns over the AstraZeneca vaccine. A number of them are still only recommending its use on older patients, generally over the age of 60. France has recommended that the AstraZeneca vaccine be reserved for people aged 55 and older. Denmark and Norway have extended a suspension of the vaccine’s use until mid-April.
CNN reports the findings of the European Medicines Agency’s Pharmacovigilance and Risk Assessment Committee, or PRAC:
PRAC chair Sabine Straus reiterated the cases of severe clotting with low blood platelet counts were extremely rare but conceded, when challenged by journalists, that EMA did not have the data to understand the extent to which benefits might still outweigh risks for particular groups, by age or sex, for example.
“At the moment that’s something that’s very difficult to answer because the clinical trials ... we do not have all the age stratified data available,” said Straus, adding that the agency planned to obtain that data and undertake further analysis.
Cooke said there was no clear risk profile found when the safety committee looked at the age and sex of people reporting these rare adverse reactions, even though a statement published by EMA earlier made clear most of the cases reported “occurred in women under 60 years of age within 2 weeks of vaccination.”
EMA’s statement called on healthcare workers and people receiving the vaccine “to remain aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within 2 weeks of vaccination.”
The AstraZeneca vaccine has not been approved for use in the United States but the publicity around concerns over the safety of that vaccine may harm the reputations of other vaccines.
Journalists, keep in mind this vaccine is important to the global vaccination efforts. The U.S. has approved shipping the AstraZeneca vaccine to Canada and Mexico and intends to share it globally through COVAX. My best advice is to avoid alarming headlines that hint at a new warning about a vaccine side effect without using AstraZeneca’s name. Don’t make the public search for the fact that this does not affect vaccines in the U.S.
Tens of thousands of children have lost a parent to COVID-19
A study published this week in the Journal of the American Medical Association Pediatrics says in the year between February 2020 and February 2021, between 37,300 and 43,000 kids lost at least one parent to the pandemic. About three-quarters of those kids were adolescents.
The study warns that we should anticipate those young people will need support, maybe for years to come.
Children who lose a parent are at elevated risk of traumatic grief, depression, poor educational outcomes, and unintentional death or suicide, and these consequences can persist into adulthood. Sudden parental death, such as that occurring owing to COVID-19, can be particularly traumatizing for children and leave families ill prepared to navigate its consequences. Moreover, COVID-19 losses are occurring at a time of social isolation, institutional strain, and economic hardship, potentially leaving bereaved children without the supports they need.
The burden will grow heavier as the death toll continues to mount. Black children are disproportionately affected, comprising only 14% of children in the US but 20% of those losing a parent to COVID-19.
The study is based on statistical modeling, not death certificates.
NBC News probed this story a couple of months ago, before the study was released, and said:
Families may not be able to hold a funeral, potentially hindering the process of accepting the reality of the death. A child may be isolated due to schools not being open, meaning support systems are not physically present in their lives. A child may fear that other adults are going to die of Covid-19, too, a worry that can be difficult to assuage when there is no clear end to the pandemic.
And among some circles, children may encounter stigma or even denial about the seriousness of the virus.
“Nobody says cancer isn’t real,” said Jessica Moujouros, program director for Children’s Grief Connection, a nonprofit that provides camps and programs for bereaved children and families. “The complications on top of complications on top of complications are just tearing my heart.”
Even as the pandemic upends daily life, there are ways that parents, educators and other adults can help a child cope with loss. There are national and local bereavement groups, many of which are doing virtual support groups.
More universities say they will require COVID-19 vaccines for students this fall
It was nearly inevitable that more schools would join Cornell University, Rutgers University, Fort Lewis College, Nova Southeastern University and St. Edward’s University in deciding that students returning this fall will have to show proof that they have been vaccinated against COVID-19.
This week, Brown University and Northeastern University joined the list. Some schools that require students to be vaccinated are not compelling teachers and staff to do the same, although they are urging them to get the shots. Nova Southeastern is requiring students, staff and teachers to show proof of vaccination.
Other universities are offering rewards for students who get vaccinated, like exempting them from mask requirements.
The Texas Tribune reports that Texas “Gov. Greg Abbott issued an executive order that would prevent all government agencies, including public universities, from instituting COVID-19 requirements for services. The order also applies to organizations that receive public money.”
If you need a COVID-19 booster, will it have to be from the same drugmaker as the original vaccine?
We do not know yet if or when you might need a booster shot in addition to your two-dose COVID-19 vaccination (or one-dose vaccination if you got the Johnson & Johnson shot). It could be that you might need a booster before the end of the year. But will you need to get the same vaccine for a booster as you got the first time?
Pfizer and Moderna are conducting drug trials now to figure it out. The Washington Post reports:
Monica Gandhi, an infectious-diseases expert at the University of California at San Francisco, said that the protection we get from the vaccines is strong and that studies have shown they trigger our long-term immune response. But if boosters are needed, Gandhi said she does not think it will be very often, and she does not think the vaccine manufacturer will matter. With the flu shot, for example, switching among manufacturers from year to year is not considered a problem, she said.
Federal health authorities have said that coronavirus vaccines are “not interchangeable” except in “exceptional situations.” Gandhi said she thinks this is only for the initial rollout and would not apply to boosters down the road.
“I think it’s completely fair to do it that way, but in the future, I can tell you that as a clinician, I’ve never looked at the vial and said, 'Oh, this was made by Johnson & Johnson, and this was made by Merck,’ ” she said. “It’s likely not going to become an issue.”
The great post-pandemic wedding recovery
