EMA starts rolling review of 5th vaccine CureVac

Hopes that the EU’s struggling vaccination rollout programmes against the coronavirus will pick up speed were reignited as a fifth COVID-19 vaccine came under review for approval, Germany’s CureVac.

If given the green light, CureVac will join PfizerBioNTech, Moderna and AstraZeneca on the list of approved vaccines.

Cyprus has ordered just 250,000 doses of the vaccine, but it is expected to boost its vaccination capacity significantly, as the national inoculation programme reaches the age group for 75 year olds.

The European Medicine Agency’s (EMA) human medicines committee (CHMP) announced it has started a rolling review of the mRNA COVID?19 vaccine developed by CureVac (CVnCoV).

The CHMP’s decision to start the rolling review is based on preliminary results from laboratory studies (non-clinical data) and early clinical studies in adults.

NovaVax’s vaccine, which employs the same technology as AstraZeneca is also undergoing a rolling review by the EMA.

CureVac is a late competitor in the race of vaccine developers working with mRNA technology, compared with Moderna and the Pfizer-BioNTech partnership, which already have their COVID-19 vaccines authorised for emergency use.

CureVac’s efforts were boosted by joining forces with big pharma Bayer.

The collaboration resembles that between BioNTech and Pfizer centred on Comirnaty, or BNT162b2, in which a big pharmaceutical helps a young biotechnology developer with more complicated issues beyond early-stage R&D.

Neither CureVac nor BioNTech had a commercial product before the pandemic. But Pfizer-BioNTech’s Comirnaty has won emergency authorisations in the EU and the U.S. backed by phase 3 data showing 95% efficacy at preventing COVID19 disease.

The efficacy of CureVac’s vaccine is still to be determined, as the results of a late-stage testing of CVnCoV kicked off in mid-December, with the goal to enrol 36,500 volunteers mainly from Europe and Latin America.

The number of doses CureVac and Bayer plan to churn out is also dwarfed by the 1.3 billion Pfizer and BioNTech have planned for 2021. Moderna’s global production goal for its mRNA vaccine, mRNA-1273, will reach 1 billion doses in 2021. CureVac’s will only reach 300 mln in 2021 and 600 mln in 2022.

The CureVac shot does hold some advantages over its mRNA rivals. The company has said that CVnCoV can remain stable at standard refrigeration of 5 degrees Celsius for at least three months.

Pfizer’s vaccines need to be stored in refrigerators with temperatures of -75 degrees Celsius and can only last up to five days in normal refrigerators, while Moderna’s could last up to a month and at a temperature of -20C.

How will it work?

Like other vaccines, CVnCoV is expected to prepare the body to defend itself against infection with COVID-19.

The SARS-CoV-2 virus uses proteins on its outer surface, called spike proteins, to enter the body’s cells and cause COVID-19. CVnCoV contains a molecule called messenger RNA (mRNA) which has instructions for making the spike protein.

The mRNA is contained in tiny particles of fats (lipids) that prevent it from being broken down too quickly.

When a person is given the vaccine, some of their cells will read the mRNA instructions and temporarily produce the spike protein. The person’s immune system will then recognise this protein as foreign and produce antibodies and activate T cells (white blood cells) against it.

If, later on, the person comes into contact with SARSCoV-2 virus, their immune system will recognise the protein and be ready to defend the body against the virus.

The mRNA from the vaccine does not stay in the body but is broken down shortly after vaccination.

AstraZeneca and NovaVax’ vaccines are protein-based vaccines which contain tiny particles made from a laboratory-grown version of the spike protein found on the surface of the SARS-CoV-2 coronavirus.

It also contains an ‘adjuvant’, a substance to help strengthen the immune responses to the vaccine.

What is a rolling review

A rolling review is a regulatory tool the EMA uses to speed up the assessment of a promising medicine during a public health emergency.

EMA said it cannot predict the overall timelines, but it should take less time than normal to evaluate an eventual application because of the work done during the rolling review.

The rolling review will continue until enough evidence is available for a formal marketing authorisation application, in which case it will be joining the three vaccines already approved and used in EU vaccination programmes.

The Health Ministry said Cyprus, like other EU states, has yet to put in an order for the Novavax COVID-19 vaccine.

Currently, the EMA has approved Pfizer-BioNTech and Moderna’s mRNA vaccines and AstraZeneca’s vaccine.