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https://www.ema.europa.eu/en/events/committee-medicinal-products-human-use-chmp-13-16-december-2021
Committee for Medicinal Products for Human Use (CHMP): 13-16 December 2021 Share
Date:
13/12/2021 to 16/12/2021
Location:
European Medicines Agency, Amsterdam, the Netherlands
The Committee for Medicinal Products for Human Use (CHMP) is the committee that is responsible for preparing the Agency's opinions on all questions concerning human medicines.
The Czechia is looking forward to the approval of the covid-19 vaccine from Novavax, and has ordered 370,000 doses. This was stated by the Minister of Health Adam Vojtěch (for YES) after today's government meeting. The vaccine of the American company is currently being evaluated by the European Medicines Agency (EMA). If the vaccine is approved, Vojtěch expects the delivery in January.
Novavax protein vaccine works on a different principle than Pfizer / BioNTech or Johnson & Johnson preparations and uses technology already used, for example, in flu and cervical cancer vaccines.
"This vaccine could be an alternative for people who, for some reason, although it is often based on various misinformation, do not have the will to be vaccinated with the existing vaccines," Vojtěch said about the Novavax preparation.
Novavax applied to the European Agency for approval of its preparation on 17 November. The EMA could issue a possible recommendation within a few weeks, after which the vaccine must be approved by the European Commission for use in the EU. The Novavax vaccine would thus become the fifth approved in the EU - vaccines from Moderna, Johnson & Johnson, AstraZeneca and Pfizer / BioNTech have so far been recommended for conditional registration.
EMA is also assessing another protein vaccine from the French manufacturer Sanofi, which, according to Vojtěch, the Czechia has also ordered. The Minister of Health also mentioned a preparation from the French company Valneva, the effectiveness of which is now being assessed by the EMA. However, according to the Minister of Health, due to the fact that this vaccine is still in the initial stages of approval, the Czech Republic is not yet dealing with the order. According to him, it would be available in April or May of the following year at the earliest.
Video Head of the Association of Nurses Šochmanová: Rejectors among paramedics are hugely illegal. Mandatory vaccination makes sense. - Markéta Volfová, Lukáš Červený
WHO chief scientist Dr Sowmya Swaminathan said on Monday the Strategic Advisory Group of Experts on Immunization (SAGE) was slated to meet on December 16 to take up emergency use approval for SII’s Covovax. SAGE advises WHO and recommends vaccine approval.
Swaminathan said the Covovax trials had shown it was safe and efficacious. She did not commit on a date for the approval, but indicated it could be expected in December.
The world has stockpiled more Covid jabs than it can use, according to the globe’s largest vaccine manufacturer.
Adar Poonawalla, chief executive of the Serum Institute of India, warned that stocks may go out of date because demand has dipped below supply.
That means Governments will have to re-order
Ask if Biden / Fauci dare to lift the South Africa travel ban if they really think Omicron is just mild
Such a short timeframe is only possible because EMA has already reviewed a substantial portion of the data on the vaccine during a rolling review.
The chemistry, manufacturing and controls (CMC) data package submitted to EMA and other global regulatory agencies leverages Novavax' manufacturing partnership with the Serum Institute of India Pvt. Ltd. (SII), the world's largest vaccine manufacturer by volume. It will later be supplemented with data from additional manufacturing sites in Novavax' global supply chain.
That’s to say NVAX needs to present supply chain data during EMA accelerated final review