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THIS WEEK, the companies behind one of the pioneers in the Covid-19 vaccine announced encouraging results from its phase 3 trial, indicating that the vaccine is 90% effective.
Although health officials and politicians have been cautious in their optimism (regulators have yet to release, peer-reviewed, or evaluate the full data), they have said it is a positive indication as we head towards the end of 2020.
Following Pfizer / BioNTech’s announcement of its vaccine candidate, European Commission President Ursula von der Leyen said the Commission will authorize a contract for up to 300 million doses.
She described the vaccine as “the most promising yet” of all possible vaccines.
The Commission has also reached agreements with three other companies that have a vaccine in development:
- Agreed with AstraZeneca to purchase 300 million doses with the option to purchase an additional 100 million.
- Approved a contract with Janssen Pharmaceutica NV (Johnson & Johnson) to purchase 200 million vaccines with the possibility of acquiring another 200 million.
- It signed a contract to buy up to 300 million doses of the Sanofi-GSK vaccine.
Irish preparations
England’s chief medical officer this week said he was hopeful the first vaccine could be seen around Christmas. British Prime Minister Boris Johnson has said he expects to have 10 million doses of the Pfizer vaccine by the end of the year if cleared by regulators and the NHS has reportedly been told to prepare for mass vaccinations. in December.
Ireland’s health officials and political leaders have held back on such ambitious commitments.
Speaking to RTÉ’s News At One yesterday, Taoiseach Micheál Martin said he believes priority groups will receive a vaccine by the first half of 2021. He said those who are not considered high risk will likely have to wait until the middle of the year or later . .
“I don’t have a precise knowledge on this yet because a lot depends on clinical trials, which are done through regulatory authorities in Europe and the FDA in the United States, and then you are in distribution, logistics and manufacturing as well.
Now some of the companies are manufacturing ahead of time and Europe has had pre-purchase agreements and we are part of that. “
Earlier this week, HSE CEO Paul Reid said health services around the world will face a number of logistical challenges once the vaccines are approved for use.
“Glass vials, necessary for manufacturing and distribution, will be in high demand around the world,” he said.
“Right now there are many manufacturing processes that will be in high demand. Transportation between ports to storage sites, there will be a massive demand for vehicles and trucks that may have that storage capacity and are not widely available. “
He said there is some capacity in large pharmaceutical companies for the type of storage needed for Pfizer vaccine and others that would need a very low temperature.
The new task force that has been established to oversee a vaccine launch will look at all of these issues, he said.
The high-level working group on vaccines will be tasked with coordinating preparations and ensuring the nationwide deployment of a Covid-19 vaccine when one is safe and ready for distribution.
The group will be chaired by Professor Brian MacCraith, former president of DCU. Medical Director Tony Holohan will also be on the vaccine task force, as will Paul Reid of HSE.
Senior Official and Chair of the Senior Officials Group on Covid-19, Liz Canavan; Barry Lowry, director of government information; and Paul Quinn, director of government procurement, will also be part of the task force.
In addition, there will be a nominee yet to be confirmed from the Department of Business, Enterprise and Innovation, who will be an expert in logistics cold chain and an expert in project management.
What we know about these four vaccines
This vaccine uses molecules called ‘messenger RNA’ (mRNA) and is a vaccine approach that has never been approved before.
Many traditional vaccines involve injecting people with a small amount of the virus.
With this new approach, the immune system never has to be exposed to the real virus. Instead, it causes human cells to grow what are known as spike proteins, which causes the immune system to produce antibodies against the virus.
The Pfizer / BioNTech Phase 3 study enrolled 43,538 participants, 42% of whom have “diverse backgrounds,” according to the companies.
This included participants between the ages of 65 and 85. He said no “serious security concerns” have been noted. There have been 94 confirmed cases of Covid-19 in the trial participants.
Pfizer / BioNTech said the vaccine was found to be more than 90% effective at preventing Covid-19 in participants.
The vaccine, like many others currently in Phase 3, requires two doses. Doctors have said this could cause logistical difficulties as it means double the number of visits to a vaccination center or wherever it is administered.
At best, it could create resource and administrative problems in developed countries, but presents a much more serious barrier for less developed countries.
Another serious obstacle is the temperature at which this vaccine should be stored: -80 degrees.
For temperatures as cold as those required by the Pfizer / BioNTech vaccination, dry ice should be incorporated into the mix. Currently, the vaccine is shipped in coolers that can be fed with dry ice to keep it frozen for 15 days. After this, it can be refrigerated for up to five days before being diluted and injected.
The medical community is already familiar with the use of the “cold chain” for vaccines like the flu. But while the laboratories have some experience with the use of dry ice, the GPs and pharmacists who play an important role in the vaccination program do not have this type of infrastructure. This is an obstacle, but not insurmountable.
- AstraZeneca / University of Oxford
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This vaccine uses a different process than the Pfizer / BioNTech vaccine. It is what is known as a non-replicating viral vector vaccine.
Viral vector strains use other forms of live virus to transport DNA into human cells, triggering an immune response. A measles virus modified with a coronavirus protein, for example, could be deployed against Covid-19.
It only takes one dose, something that will likely make you one of the most attractive candidates. The vaccine also does not require the intense cold temperatures necessary for mRNA vaccines.
In September, trials of this coronavirus vaccine were stopped after a volunteer from the UK developed an unexplained illness. British regulators and an independent review concluded that the disease was not a side effect of the vaccine.
Last month it was confirmed that a volunteer participating in clinical trials of the vaccine developed by the University of Oxford had died, but the man had received a placebo instead of the active vaccine.
The vaccine’s developers have said that it produces an immune response in older age groups, as well as in younger people. AstraZeneca and the University of Oxford have said that data from their late-stage clinical trials are expected by the end of 2020.
- Janssen Pharmaceutica NV (Johnson & Johnson)
This is also a non-replicating viral vector vaccine. It uses a dose of a cold-causing adenovirus, modified so that it can no longer replicate. This is combined with a part of the new virus, SARS-CoV-2, called a spike protein that it uses to invade human cells.
In October, the trial was stopped for safety reasons after a patient fell ill. Since then, the company has said that no clear cause was identified, but based on “information gathered to date and input from independent experts,” it found no evidence that the candidate vaccine caused the event.
Late last month, it said it was preparing to resume Phase 3 of its trial, for which it is enrolling up to 60,000 people at 180 sites. The company said this will include “a significant representation of those who are over 60 years old.”
Preclinical tests in rhesus macaque monkeys that were published in the journal Nature showed that this vaccine provided complete or near complete protection against virus infection in the lungs and nose.
The candidate vaccine from the French company Sanofi and the British firm GlaxoSmithKline is still in phase 1 and 2 trials, and the first results are expected later this month or early December.
The companies have signed an agreement with Covax, the global inoculation plan backed by the World Health Organization, to supply 200 million doses. It has also signed an agreement with the United States to supply more than 100 million doses.
This vaccine uses the same approach as one of your seasonal influenza vaccines and is combined with a substance that boosts the vaccine.
Sanofi is also working with the American company Translate Bio on an mRNA vaccine, but this is at an earlier stage.
– With reporting by Christina Finn.
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