A top official at the European Medicines Agency says there’s a causal link between AstraZeneca’s coronavirus vaccine and rare blood clots, but that it’s unclear what the connection is and that the benefits of taking the shot still outweigh the risks of getting COVID-19.
Marco Cavaleri, head of health threats and vaccine strategy at the Amsterdam-based agency, told Rome’s Il Messaggero newspaper on Tuesday that the European Union’s medicines regulator is preparing to make a more definitive statement on the topic this week.
Asked about Cavaleri’s comments, the EMA press office said its evaluation “has not yet reached a conclusion and the review is currently ongoing.” It said it planned a press conference as soon as the review is finalized, possibly Wednesday or Thursday.
Based on the evidence so far, Cavaleri said there’s a clear association between the AstraZeneca vaccine and the dozens of rare blood clots that have been reported worldwide amid the tens of millions of AstraZeneca shots that have been given out.
“It is becoming more and more difficult to affirm that there isn’t a cause-and-effect relationship between AstraZeneca vaccines and the very rare cases of blood clots associated with a low level of platelets,” Cavaleri was quoted as saying.
AstraZeneca did not immediately respond to a request for comment. Late in the day, however, the pharmaceutical company and Oxford University, which developed the vaccine, announced they were pausing the trial of their jabs in children while British regulators investigate the potential blood clot link in adults.
“Whilst there are no safety concerns in the pediatric clinical trial, we await additional information” from the British regulator, an Oxford spokesperson said in a statement.
In Geneva, the World Health Organization said its experts were also evaluating a possible link between the AstraZeneca vaccine and rare blood clots — and that it might have a “fresh, conclusive assessment” before Thursday.
In March, more than a dozen countries, including Germany, suspended using AstraZeneca over the blood clot issue. Most EU nations restarted on March 19 — some with age restrictions — after the EMA said the benefits of the vaccine outweighed the risks of not inoculating people against COVID-19. At the time, the EMA recommended the vaccine’s leaflet be updated with information about the rare clots.
Any further doubts about the AstraZeneca vaccine would be a setback for the shot, which is critical to Europe’s immunization campaign and a linchpin in the global strategy to get vaccines to poorer countries. The AstraZeneca vaccine is cheaper and easier to use than rival vaccines from Pfizer and Moderna and has been endorsed for use in over 50 countries, including by the 27-nation EU and the World Health Organization. U.S. authorities are still evaluating the vaccine.
Cavaleri said while EMA was prepared to declare a link, further study was still needed to understand why and how the phenomenon occurs.
He said the rare blood clots, including some in the brain, coupled with a low level of blood platelets that may make people at risk of serious bleeding, “seem to be the key event to study further.” Cavaleri promised more details soon, adding: “In the coming hours, we will say that the link is there, how this happens we still haven’t figured out.”
Cavaleri said the biological mechanism for how the vaccine might be causing the rare clots was still unknown and if it was linked to how the shot is made, other vaccines with similar technologies might also need to be evaluated.
He stressed the risk-benefit analysis remained positive for the AstraZeneca jab, even for young women who appear to be more affected by the clots.
“Let’s not forget that young women also end up in intensive care with COVID. So we need to do very meticulous work to understand if the risk-benefit analysis remains for all ages,” he was quoted as saying.
He ruled out a preventive therapy to address the rare blood clots, saying there is still too much unknown about the phenomenon.
Even after the March 19 restart, the Dutch and German governments suspended the jabs for people under 60 and some Europeans have been shying away from getting a shot.
Romania’s national vaccination committee’s chief, Valeriu Gheorghita, said Tuesday that since March, 207,000 people in Romania had canceled their AstraZeneca vaccine appointments and another 92,000 simply didn’t show up.
“It is a high percentage, a third of people scheduled who did not show up,” Gheorghita told reporters.
British Prime Minister Boris Johnson declined to be drawn directly into the latest warnings about the vaccine but urged people to look at the advice from Britain’s independent Medicines and Healthcare Regulatory Agency.
“Their advice to people is to keep going out there, get your jab, get your second jab,” he said during a visit Tuesday to an AstraZeneca facility in Macclesfield, in northwest England.
Last week, Britain’s MHRA said seven people had died in the U.K. due to blood clots after getting the AstraZeneca jab. It said it wasn’t clear if the shots are causing the clot and that it was undertaking a “rigorous review” into the reports. The agency said it had identified 30 blood clot cases out of 18.1 million AstraZeneca jabs given by March 24.
Adam Finn, a professor of pediatrics at the University of Bristol, said the latest surge of COVID-19 cases that is filling up hospitals across Europe should prompt people to get vaccinated as soon as possible.
“If you are currently being offered a dose of Oxford-AstraZeneca vaccine, your chances of remaining alive and well will go up if you take the vaccine and will go down if you don’t,” he said.
ROME (AP) — By NICOLE WINFIELD and PAN PYLAS
Sleep therapy device raises over $315.38 in crowdfunding
A UK-designed sleep therapy solution with global ambitions raised over $314.21 in the first week of a Crowdcube crowdfunding campaign.
SleepCogni, a portable device with data support for people suffering from insomnia, has so far attracted funds from 157 different investors in this latest fundraiser that combines venture capital investments and crowdfunding.
The firm’s latest lenders include Chasnay Capital Investments, a new private investment fund founded by three former senior executives from General Electric (GE) Healthcare.
Co-founded by Sheffield-based entrepreneur Richard Mills, who has personally suffered from sleeping disorders, and Dutch chronobiologist and sleep expert, Dr Maan van de Werken, said the device allows users to self-manage their insomnia, a condition which affects one in three people across the world.
“Our successful crowdfund campaign builds on the momentum of last month’s FDA registration and the completion of clinical trials where SleepCogni achieved extraordinary results reducing clinical insomnia in just seven days.”
Reinaldo Garcia from Chasnay Capital Investments added: “We’re excited by our investment into SleepCogni for many reasons: its patented technology and clinically validated solution addresses an unmet need in the global sleep aid market, and the company is backed by an excellent team. As experienced global senior leaders with a proven track record, we can add value in this next exciting stage of the business and help SleepCogni scale on a global level.”
Pfizer vaccine efficacy falls to 84% after 6 months
Pfizer and BioNTech published on Wednesday new data indicating their COVID-19 vaccine efficacy decline from 96 percent to 84 percent over six months.
These numbers are regarded as a big motivator to the drug makers currently developing a third “booster shot” to target the Indian Delta variant.
The released data shows that the antibody levels are much higher against the Alpha coronavirus variant and the South African Beta variant, after a third dose.
Based on the figures, the efficacy “declined gradually” as it dropped from 96 percent during the first week to around two months after receiving a second jab. The dose’s effectiveness then plummeted to 83.7 percent four to six months later with an average drop of 6 percent over the last two months.
The findings may be considered by U.S. health authorities in deciding when the pair’s booster shot might be needed.
The data, which involved tests of 23 people, was published by Pfizer and has not been peer reviewed by the scientific community.
The announcement of the data and was released on the day of the company’s earnings call.
During the call, Mikael Dolsten chief scientific officers described the new data on a third dose of vaccine “encouraging.”
“Receiving a third dose more than six months after vaccination, when protection may be beginning to wane, was estimated to potentially boost the neutralizing antibody titers in participants in this study to up to 100 times higher post-dose three compared to pre-dose three,” Dolsten said in a statement.
Despite Pfizer and its German partner BioNTech’s booster shot plans, both Centers for Disease Control and Prevention (CDC) as well as Food and Drug Administration (FDA) released a joint statement highlighting that Americans who have been fully vaccinated do not need a booster shot at this moment in time.
The statement noted that FDA, CDC, and National Institutes of Health (NIH) are engaged in a science-based process to consider whether or when a booster might be necessary.
Google delays return to office, mandates vaccines
Google is postponing a return to the office for most workers until mid-October and rolling out a policy that will eventually require everyone to be vaccinated once its sprawling campuses are fully reopened.
The more highly contagious delta variant of the coronavirus is driving a dramatic spike in COVID-19 cases and hospitalizations. Google’s Wednesday announcement was shortly followed by Facebook, which also said it will make vaccines mandatory for U.S. employees who work in offices. Exceptions will be made for medical and other reasons.
In an email sent to Google’s more than 130,000 employees worldwide, CEO Sundar Pichai said the company is now aiming to have most of its workforce back to its offices beginning Oct. 18 instead of its previous target date of Sept. 1.
The decision also affects tens of thousands of contractors who Google intends to continue to pay while access to its campuses remains limited.
“This extension will allow us time to ramp back into work while providing flexibility for those who need it,” Pichai wrote.
And Pichai disclosed that once offices are fully reopened, everyone working there will have to be vaccinated. The requirement will be first imposed at Google’s Mountain View, California, headquarters and other U.S. offices, before being extended to the more than 40 other countries where Google operates.
“This is the stuff that needs to be done, because otherwise we are endangering workers and their families,” said Dr. Leana Wen, a public health professor at George Washington University and a former health commissioner for the city of Baltimore. “It is not fair to parents to be expected to come back to work and sit shoulder-to-shoulder with unvaccinated people who could be carrying a potentially deadly virus.”
Because children under the age of 12 aren’t currently eligible to be vaccinated, parents can bring the virus home to them from the office if they are around unvaccinated colleagues, Wen said.
Various government agencies already have announced demands for all their employees to be vaccinated, but the corporate world so far has been taking a more measured approach, even though most lawyers believe the mandates are legal.
Delta and United airlines are requiring new employees to show proof of vaccination. Goldman Sachs and Morgan Stanley are requiring their employees to disclose their vaccination status, but are not requiring staffers to be vaccinated.
Less than 10% of employers have said they intend to require all employees to be vaccinated, based on periodic surveys by the research firm Gartner.
While other major technology companies may follow suit now that Google and Facebook have taken stands on vaccines, employers in other industries still may be reluctant, predicted Brian Kropp, chief of research for Gartner’s human resources practice.
“Google is seen as being such a different kind of company that I think it’s going to take one or two more big employers to do something similar in terms of becoming a game changer,” Kropp said.
Google’s vaccine mandate will be adjusted to adhere to the laws and regulations of each location, Pichai wrote, and exceptions will be made for medical and other “protected” reasons.
“Getting vaccinated is one of the most important ways to keep ourselves and our communities healthy in the months ahead,” Pichai explained.
Google’s decision to require employees working in the office to be vaccinated comes on the heels of similar moves affecting hundreds of thousands government workers in California and New York as part of stepped-up measures to fight the delta variant. President Joe Biden also is considering mandating all federal government workers be vaccinated.
The rapid rise in cases during the past month has prompted more public health officials to urge stricter measures to help overcome vaccine skepticism and misinformation.
The vaccine requirement rolling out in California next month covers more than 240,000 government employees. The city and county of San Francisco is also requiring its roughly 35,000 workers to be vaccinated or risk disciplinary action after the Food and Drug Administration approves one of the vaccines now being distributed under an emergency order.
It’s unclear how many of Google’s workers still haven’t been vaccinated. In his email, Pichai described the vaccination rate at the company as high.
Google’s decision to extend its remote-work follows a similar move by another technology powerhouse, Apple, which recently moved its return-to-office plans from September to October, too.
The delays by Apple and Google could influence other major employers to take similar precautions, given that the technology industry has been at the forefront of the shift to remote work triggered by the spread of the novel coronavirus.
Even before the World Health Organization declared a pandemic in March 2020, Google, Apple and many other prominent tech firms had been telling their employees to work from home. This marks the third time Google has pushed back the date for fully reopening its offices.
Google’s vaccine requirement also could embolden other employers to issue similar mandates to guard against outbreaks and minimize the need to wear masks in the office.
While most companies are planning to bring back their workers at least a few days a week, others in the tech industry have decided to let employees do their jobs from remote locations permanently.
SAN RAMON, Calif. (AP)
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