Transplant centres in Western Canada have stopped short of requiring organ recipients to be fully vaccinated against COVID-19, but they say conversations about such a policy are ongoing.
Some centres in other parts of the country, including Ontario, are requiring proof of vaccination before a patient is approved for the life-saving surgery.
BC Transplant, located in Vancouver, said COVID-19 vaccination is not required to be eligible for a transplant, but programs in the province are actively reviewing it.
“The transplant programs are strongly encouraging all pre-transplant patients to be vaccinated against COVID-19, as they do with many other vaccine-preventable infections,” the agency said in a statement.
Similarly, Alberta Health Services told The Canadian Press it has long been a requirement that patients preparing for transplant have all vaccines to help maximize their chances of success post-transplant. It notes, however, it’s only a practice guideline at this point.
Saskatchewan has also not made any changes.
“Saskatchewan’s organ transplant teams are strongly supportive of all recipients and donors having COVID vaccinations, and the issue of requiring these vaccinations in recipients is actively being discussed,” Lisa Thomson, a spokeswoman for the Saskatchewan Health Authority, said in a statement.
The Ajmera Transplant Centre at Toronto’s University Health Network recently announced its decision to implement a policy that requires patients who may benefit from receiving a transplant be fully vaccinated against COVID-19 before they are listed for solid organ transplant.
However, there may be exemptions for medical reasons or in cases of urgent need of a transplant.
“We all recognize that (COVID-19) is a massive, massive risk factor. The prudent and ethical thing to do to protect patients and to protect each other, and show fidelity and respect to those organ donors, is to require this (policy) to be a price of pass and go,” UHN president and chief executive officer Kevin Smith said in an interview.
The decision to enact the policy is based on a few factors, according to the organization.
It said transplant patients are severely immunocompromised because of lifelong treatment to prevent rejection of a new organ. If someone who is immunocompromised gets COVID-19, they are at a very high risk of being hospitalized or placed on ventilation.
Unvaccinated recipients could also pose a risk to other patients post-surgery. Transplant recipients have high health needs after their transplants and require frequent visits to a hospital. These individuals may pose a greater risk of spreading illness, should they get infected, to other immunocompromised patients in an inpatient or outpatient setting.
“Thinking about an outbreak in an environment like that would be just a massacre,” Smith said.
Infectious disease experts noted this type of policy isn’t new.
“There’s just requirements pre-transplant in order to be eligible for listing. Some of it is complying with some of the medical measures to see if patients would be eligible,” said Dr. Dima Kabbani, an assistant professor in the division of infectious diseases at the University of Alberta.
Kabbani added pre-transplant vaccine recommendations are already in place for hepatitis B, pneumococcal disease and influenza.
Manitoba’s Shared Health said there is no requirement for Manitobans awaiting a transplant to be vaccinated for COVID-19, but noted patients may be required to show proof of vaccinationif there are requirements elsewhere.Kidney transplants are performed in the province while all other organ transplants take place in other provinces.
Jessica Bailey, 35, is living with stage five kidney disease and awaiting a transplant in Saskatoon.
The government has postponed surgeries as the province deals with a devastating fourth wave of COVID-19.
Bailey said she is not in favour of requiring recipients to be vaccinated against COVID-19. She said she is double vaccinated but believes recipients should still have the choice on whether they want the vaccine.
She does encourage patients who may be on the fence to look at the bigger picture.
“If you can get a transplant just by getting the vaccine, go and do it. Pick and choose your battles,” Bailey said.
This report by The Canadian Press was first published on Oct. 15, 2021.
This story was produced with the financial assistance of the Facebook and Canadian Press News Fellowship.
Brittany Hobson, The Canadian Press
Merck’s COVID-19 pill significantly less effective in new analysis
Merck & Co said on Friday updated data from its study of its experimental COVID-19 pill showed the drug was significantly less effective in cutting hospitalizations and deaths than previously reported.
The drugmaker said its pill showed a 30% reduction in hospitalizations and deaths, based on data from 1,433 patients. In October, its data nL1N2QX0QJ showed a roughly 50% efficacy, based on data from 775 patients. The drug, molnupiravir, was developed with partner Ridgeback Biotherapeutics.
The lower efficacy of Merck’s drug could have big implications in terms of whether countries continue to buy the pill. Interim data from 1,200 participants in Pfizer Inc’s trial for its experimental pill, Paxlovid, showed an 89% reduction in hopsitalizations and deaths.
Merck’s shares fell 3.5% to $79.39 in morning trading.
Merck released the data before the U.S Food and Drug Administration published a set of documents on Friday intended to brief a panel of outside experts who will meet on Tuesday to discuss whether to recommend authorizing the pill.
The agency’s staff did not make their own recommendation as to whether the pill should be authorized.
FDA staff asked the panel to discuss whether the benefits of the drug outweigh the risks and whether the population for whom the drug should be authorized should be limited.
They also asked the committee to weigh in on concerns over whether the drug could encourage the virus to mutate, and how those concerns could be mitigated.
Pills like molnupiravir and Paxlovid could be promising new weapons in the fight against the pandemic, as they can be taken as early at-home treatments to help prevent COVID-19 hospitalizations and deaths. They could also become important tools in countries and areas with limited access to vaccines or low inoculation rates.
The Merck and Pfizer pills are cheaper to produce and easier to administer than existing treatment options such as antibody therapies from Regeneron and Eli Lilly, which are mostly administered as intravenous infusions.
The two experimental drugs have different mechanisms of action. Merck’s is designed to introduce errors into the genetic code of the virus. Pfizer’s drug, part of a class known as protease inhibitors, is designed to block an enzyme the coronavirus needs in order to multiply.
Merck filed for a U.S. authorization of molnupiravir on Oct. 11, following the interim data, and submitted the updated data to the FDA this week.
The molnupiravir arm of the study had a hospitalization and death rate of 6.8%, according to the updated data. The placebo group had a hospitalization and death rate of 9.7%.
One patient in the molnupiravir arm died, versus nine in the placebo group.
The United Kingdom conditionally approved molnupiravir, branded as Lagevrio, earlier this month.
Merck expects to produce 10 million courses of the treatment by the end of this year, with at least 20 million set to be manufactured in 2022. It has a contract with the U.S. government to supply as many as 5 million courses at a price of $700 per course. Several other countries have already secured millions of courses of the pill.
Merck has said data shows molnupiravir is not capable of inducing genetic changes in human cells, but men enrolled in its trials had to abstain from heterosexual intercourse or agree to use contraception. Women of child-bearing age also had to use birth control.
Still, the FDA said in its briefing document that there are safety concerns about potential birth defects from the drug and asked the panel to discuss whether the drug should be available to pregnant women.
(Reporting by Manas Mishra in Bengaluru and Michael Erman in New JerseyEditing by Shounak Dasgupta, Frances Kerry and Emelia Sithole-Matarise)
Brazil health regulator calls for Africa travel restrictions, Bolsonaro noncommittal
Brazilian health regulator Anvisa recommended on Friday that travel be restricted from some African countries due to the detection of a new COVID-19 variant, though it was unclear if President Jair Bolsonaro would adopt any measures.
Anvisa said its recommendation, which would need government approval to be implemented, was to immediately suspend flights from South Africa, Botswana, Lesotho, Eswatini, Namibia and Zimbabwe.
The EU and Britain are already tightening border controls as researchers look into whether the new mutation is vaccine-resistant.
Brazil’s Health Ministry said in a separate note that the new B.1.1.529 variant named Omicron poses a potential future threat, but that its epidemiological impact was unclear.
After the Anvisa statement, Bolsonaro told journalists he was considering taking measures related to the variant but continued to emphasize that he was against severe coronavirus-related restrictions.
“Brazil can’t handle another lockdown. There’s no use getting terrified,” he said after a military event in Rio de Janeiro. “I’m going to take rational measures.”
Bolsonaro has been widely criticized by public health experts for his management of the pandemic, railing against lockdowns, often refusing to wear a mask in public and choosing not to get vaccinated. Brazil has the world’s second-highest death toll from the virus, behind only the United States.
The World Health Organization (WHO) has cautioned countries against hastily imposing travel restrictions due to the variant, saying they should take a “risk-based and scientific approach.”
In its technical note, Anvisa said that foreigners who have been to at least one of the six African countries cited in the prior 14 days should not be allowed to land in Brazil, while Brazilians arriving from those nations should be required to quarantine.
The health agency said, “The new variant appears to have a higher transmissibility.”
Anvisa President Antonio Barra Torres told news channel GloboNews that travel restrictions are a necessary preventive measure and he expected the government to make a decision as soon as possible.
The news of the variant hammered travel stocks in Brazil.
(Reporting by Gabriel Araujo in Sao Paulo and Lisandra Paraguassu in BrasiliaAdditional reporting by Rodrigo Viga Gaier in Rio de Janeiro and Eduardo Simoes in Sao PauloWriting by Stephen Eisenhammer and Gram SlatteryEditing by Brad Haynes and Alistair Bell)
Novavax developing vaccine that targets new COVID-19 variant
Novavax Inc said on Friday it had started working on a version of its COVID-19 vaccine to target the variant detected in South Africa and would have the shot ready for testing and manufacturing in the next few weeks.
The company’s COVID-19 shot contains an actual version of the virus’ spike protein that cannot cause disease but can trigger the immune system. The vaccine developer said it had started developing a spike protein specifically based on the known genetic sequence of the variant, B.1.1.529.
“The initial work will take a few weeks,” a company spokesperson said. Shares of the company closed up nearly 9% on Friday.
Novavax’s vaccine received its first emergency use approval earlier this month in Indonesia followed by the Philippines.
The company has said it is on track to file for U.S. approval by the end of the year. It has also filed for approvals with the European Medicines Agency as well as in Canada.
Other vaccine developers, including Germany’s BioNTech SE and Johnson & Johnson, have said they are testing the effectiveness of their shots against the new variant, which is named Omicron by the World Health Organisation.
Inovio Pharmaceuticals Inc said it had begun testing its vaccine candidate, INO-4800, to evaluate its effectiveness against the new variant. The company expects the testing to take about two weeks.
Inovio also said it was simultaneously designing a new vaccine candidate that specifically targeted Omicron.
“Best case scenario, INO-4800 … will be completely resilient against omicron, but if that’s not the case then we will have a newly designed vaccine ready to go if need be,” said Kate Broderick, senior vice president of Inovio’s R&D division.
Earlier this month, Inovio resumed a late-stage trial of its vaccine in the United States after 14 months on clinical hold.
(Reporting by Manojna Maddipatla and Mrinalika Roy in Bengaluru; Editing by Anil D’Silva)
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