A rolling review of Moderna's Covid-19 vaccine candidate has been started by authorities in Switzerland so that the regulators are able to grant a speedy approval of the vaccine if the vaccine candidate reveals good results in the clinical trials, said the country's drug regulator on Friday.
In similar rolling reviews are also being conducted to scrutinize the progress of experimental vaccines being developed by AstraZeneca as well as Pfizer and BioNTech the regulator Swissmedic.
Under the so-called rolling review processes, applications for Covid-19 medicinal products can be filed by drug companies even before companies are able to complete the development work for the vaccines and prior to companies have the complete supporting documentation in hand required for a formal and conventional approval of vaccines by health regulators.
There is enough data available with it for regulators to conduct a first interim analysis of its late-stage Covid-19 vaccine trial, United States based drug maker Moderna had said this week. That announcement by the company had raised hopes globally that the company would soon release the initial results of the trials.
According to an announcement made on Monday by the drug makers Pfizer and BioNTech, the trials for the companies’ vaccine candidate was found by the firms to have shown more than 90 per cent effective against the disease.
Regulator Swissmedic said in a statement about the rolling review that the regulator can thereby get an initial picture of the benefit-risk profile of the vaccine candidates prior to the completion of the authorisation studies. Using this method of review, the regulator would be able to accelerate the review process while it would at the same time be able to save on time and maintain the same level of careful checking of all requirements relating to safety, efficacy and quality of the vaccine candidate, Swissmedic said.
The regulator was also working with other drug regulators around the world as part of the review, Swissmedic said.
In order to purchase successful Covid-19 vaccines, Switzerland has already set aside 400 million Swiss francs ($437 million) and has also reserved a total of about 16 million doses of the vaccine shots that are currently under development by the firms Moderna, AstraZeneca and Pfizer/BioNTech.
(Source:www.jpost.com)
In similar rolling reviews are also being conducted to scrutinize the progress of experimental vaccines being developed by AstraZeneca as well as Pfizer and BioNTech the regulator Swissmedic.
Under the so-called rolling review processes, applications for Covid-19 medicinal products can be filed by drug companies even before companies are able to complete the development work for the vaccines and prior to companies have the complete supporting documentation in hand required for a formal and conventional approval of vaccines by health regulators.
There is enough data available with it for regulators to conduct a first interim analysis of its late-stage Covid-19 vaccine trial, United States based drug maker Moderna had said this week. That announcement by the company had raised hopes globally that the company would soon release the initial results of the trials.
According to an announcement made on Monday by the drug makers Pfizer and BioNTech, the trials for the companies’ vaccine candidate was found by the firms to have shown more than 90 per cent effective against the disease.
Regulator Swissmedic said in a statement about the rolling review that the regulator can thereby get an initial picture of the benefit-risk profile of the vaccine candidates prior to the completion of the authorisation studies. Using this method of review, the regulator would be able to accelerate the review process while it would at the same time be able to save on time and maintain the same level of careful checking of all requirements relating to safety, efficacy and quality of the vaccine candidate, Swissmedic said.
The regulator was also working with other drug regulators around the world as part of the review, Swissmedic said.
In order to purchase successful Covid-19 vaccines, Switzerland has already set aside 400 million Swiss francs ($437 million) and has also reserved a total of about 16 million doses of the vaccine shots that are currently under development by the firms Moderna, AstraZeneca and Pfizer/BioNTech.
(Source:www.jpost.com)
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