The Committee for Human Medicines (CHMP) of the European Medicines Agency (EMA) has started an ongoing review of VLA2001, a vaccine against Covid-19 developed by Valneva. This is learned from Ema who explained that the committee’s decision to initiate the continuous review is based on the preliminary results of laboratory studies (non-clinical data) and early clinical studies in adults.
These studies suggest that the vaccine triggers the production of antibodies that target Sars-CoV-2, the virus that causes Covid-19, and may help protect against the disease. The EMA will evaluate the data as it becomes available to decide whether the benefits outweigh the risks. The review will continue until sufficient evidence is available for a formal marketing authorization application.
Novavax vaccine, EMA: “It could be authorized in a few weeks”
November 30, 2021
The timing of the evaluation process
Although the EMA said it could not predict the overall timeline, it should take less time than normal to evaluate a possible application due to the work done during the ongoing review.
What kind of vaccine is Valneva
Unlike the other four already licensed vaccines (two mRna and two viral vector), the Valneva vaccine contains inactivated (killed) Sars-CoV-2 virus, which cannot cause disease, and also contains two ‘adjuvants’, substances which help strengthen the immune response to the vaccine.
When a person is given this shield product, the immune system identifies the inactivated virus as foreign and produces antibodies. If, subsequently, the vaccinee comes into contact with Sars-CoV-2, the immune system will recognize the virus and be ready to defend itself.
Covid vaccines, what is the third dose for?
by Aureliano Stingi
November 29, 2021
The other vaccines under evaluation by Ema
With the protein vaccine Novavax so the ok is expected shortly, probably by the end of the year, 5 new vaccines are being evaluated by the European Medicines Agency 2 years after the discovery of the new virus.
Covid, Novavax vaccine: why it is different from others
November 18, 2021
This is the Chinese Sinovac True Cell, from the Russian Sputnik, by Vidprevtyn of the French Sanofi Pasteur and of Vla2001 of Valneva, also this French.
What is the rolling review
The rolling review is a review mechanism that speeds up evaluation because it allows you to view and analyze product data as it becomes available.
Third dose Covid vaccine, which boosters work the most?
by Noemi Penna
03 December 2021
Vaccines already authorized in the EU
There are four vaccines already authorized in the EU: – Comirnaty by Pfizer / BioNTech, Spikevax by Moderna, Vaxzevria by AstraZeneca and Janssen’s vaccine, J&J. The first two are based on mRna technology, the others (AstraZeneca and J&J) are viral vector.
The Valneva vaccine and the EU
On November 10, the European Commission approved an eighth contract with a pharmaceutical company to purchase its COVID-19 vaccine candidate. The contract with Valneva foresees that all EU Member States will be able to purchase nearly 27 million doses in 2022, but also the possibility that the vaccine will be adapted to new variants of viral strains and that Member States will place additional orders in 2023 to buy up to 33 million more vaccines.
The contract with Valneva enriches an already extensive portfolio of vaccines to be produced in Europe which have been assured of availability, which includes contracts already signed with AstraZeneca, Sanofi-GSK, Janssen Pharmaceutica NV, BioNtech-Pfizer, CureVac, Moderna and Novavax.