EMA’s human medicines committee (CHMP) has started a rolling review of Sputnik V (Gam-COVID-Vac), a COVID-19 vaccine1 developed by Russia’s Gamaleya National Centre of Epidemiology and Microbiology. The EU applicant for this medicine is R-Pharm Germany GmbH.
The CHMP’s decision to start the rolling review is based on results from laboratory studies and clinical studies in adults. These studies indicate that Sputnik V triggers the production of antibodies and immune cells that target the SARS-CoV-2 coronavirus and may help protect against COVID-19.
EMA will evaluate data as they become available to decide if the benefits outweigh the risks. The rolling review will continue until enough evidence is available for formal marketing authorization application.
EMA will assess Sputnik V’s compliance with the usual EU standards for effectiveness, safety and quality. While EMA cannot predict the overall timelines, it should take less time than normal to evaluate an eventual application because of the work done during the rolling review.
EMA will communicate further when the marketing authorization application for the vaccine has been submitted.
How is the vaccine expected to work?
Sputnik V is expected to work by preparing the body to defend itself against infection with the SARS-CoV-2 virus. This virus uses proteins on its outer surface, called spike proteins, to enter the body’s cells and cause COVID-19.
Sputnik V is made up of two different viruses belonging to the adenovirus family, Ad26 and Ad5. These adenoviruses have been modified to contain the gene for making the SARS-CoV-2 spike protein; they cannot reproduce in the body and do not cause disease. The two adenoviruses are given separately: Ad26 is used in the first dose and Ad5 is used in the second to boost the vaccine’s effect.
Once it has been given, the vaccine delivers the SARS-CoV-2 gene into cells in the body. The cells will use the gene to produce the spike protein. The person’s immune system will treat this spike protein as foreign and produce natural defences − antibodies and T cells − against this protein.
If, later on, the vaccinated person comes into contact with SARS-CoV-2, the immune system will recognise the spike protein on the virus and be prepared to attack it: antibodies and T cells can work together to kill the virus, prevent its entry into the body’s cells and destroy infected cells, thus helping to protect against COVID-19.
|What is a rolling review? A rolling review is a regulatory tool that EMA uses to speed up the assessment of a promising medicine during a public health emergency. Normally, all data on a medicine or vaccine’s effectiveness, safety and quality and all required documents must be ready at the start of the evaluation in a formal application for marketing authorization. In the case of a rolling review, EMA’s human medicines committee (CHMP) reviews data as they become available from ongoing studies. Once the CHMP decides that sufficient data are available, the company can submit a formal application. By reviewing the data as they become available, the CHMP can come to an opinion on the medicine’s authorisation sooner.During the rolling review, and throughout the pandemic, EMA and its scientific committees are supported by the COVID-19 EMA pandemic task force (COVID-ETF). This group brings together experts from across the European medicines regulatory network to advise on the development, authorisation and safety monitoring of medicines and vaccines for COVID-19 and facilitate quick and coordinated regulatory action.|
1 Sputnik V is made up of two components comprising different viruses belonging to the adenovirus family, Ad26 and Ad5. Separate submissions have been made for each component.
Therapeutics Strategy - First rolling review of a new COVID-19 medicine
The European Medicines Agency has today (7 May) started the rolling review of sotrovimab (VIR-7831), a monoclonal antibody developed for the treatment of COVID-19. The review follows hot on the heels of the EU COVID-19 Therapeutics Strategy presented yesterday and is a first step towards the Strategy's target of starting seven rolling reviews of COVID-19 therapeutics in 2021. The rolling review launched by EMA will assess sotrovimab's effectiveness in preventing hospitalization and death; safety and quality. A rolling review is quicker than a regular evaluation as data is reviewed as it comes in. Should the European Medicines Agency recommend authorising the treatment at the end of its review, the European Commission will move swiftly to authorize it.
The EU Therapeutics Strategy supports the development and availability of much needed COVID-19 therapeutics and covers the lifecycle of medicines: from research, development and manufacturing to procurement and deployment. It is part of the strong European Health Union, in which all EU countries prepare and respond together to health crises and ensure the availability of affordable and innovative medical supplies – including the therapeutics needed to treat COVID-19. More details on the EU Therapeutics Strategy are available in a press release and factsheet.
Kazakhstan to deliver humanitarian assistance to India
Kazakhstan will provide humanitarian assistance to India due to the sharp deterioration of the epidemiological situation in this country, reported the Akorda Press, writes Zhanna Shayakhmetova.
This was announced at the meeting of Kazakh President Kassym-Jomart Tokayev and Prime Minister Askar Mamin on May 7.
President Tokayev instructed the government to dispatch 6 million medical masks, 400,000 respirators, 50,000 anti-plague suits, and 105 portable artificial lung ventilation devices made in Kazakhstan.
India observed a record daily rise in coronavirus cases on Friday, bringing total new cases for the week to 1.57 million, according to Reuters.
India is now the second most corona-affected country with the overall cases standing at 21.49 million.
On May 4, Tokayev delivered a message to Indian Prime Minister Narendra Modi to express “deep solidarity with the Indian nation over the devastating COVID-19 surge in their country.”
The President noted that Kazakhstan is ready “to unite efforts with our Indian friends to contain the spread of the pandemic and provide every possible assistance in the spirit of enduring friendship and mutual support between our states.”
Earlier, it was reported that Kazakhstan will provide humanitarian aid that consists of 10,000 tons of flour to Kyrgyzstan.
“Guided by the principles of friendship, alliance and strategic partnership with Kyrgyzstan, President Kassym-Jomart Tokayev decided to provide humanitarian assistance to the fraternal Kyrgyz people on behalf of the Kazakh people,” President’s spokesperson Berik Uali wrote on his Facebook on May 6.
India: EU mobilizes an initial €2.2 million in emergency funding for the vulnerable during COVID-19
The Commission has announced that it will allocate an initial €2.2 million in emergency funding to respond to the drastic surge in COVID-19 cases in India. The funding will support the World Health Organization (WHO) for a 6-month case management of COVID-19 patients, as well as strengthening laboratory capacity for COVID-19 testing. Crisis Management Commissioner Janez Lenarčič said: “We are providing additional EU support towards the fight against COVID-19 in India. This comes on top of the generous and swift assistance from EU member states that stepped up as part of Team Europe to offer critical supplies of oxygen, ventilators and medicines over the last few days. We stand ready to work with the WHO and other partners on the ground to jointly fight this battle at this difficult time – we are stronger together.”
Member states have already mobilized supplies of urgently needed oxygen, ventilators and medicines from Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Ireland, Italy, Luxembourg, Netherlands, Portugal, Romania, Spain and Sweden to India over the last week via the EU Civil Protection Mechanism.
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