European medicines watchdog expected to give Pfizer first COVID-19 vaccine authorisation

Health minister Chris Fearne: Malta could start receiving COVID vaccine in January

Europe’s medicines watchdog is expected to give Pfizer the first market authorisation for a COVID-19 vaccine in December, Chris Fearne said.

The Deputy Prime Minister said the European Medicines Agency is expected to receive the company’s final submissions and once approval is given towards the end of December, the vaccine roll out will start immediately.

Fearne told MaltaToday in an interview published today that Malta has half-a-million coronavirus vaccine doses ordered from Pfizer and the first batch could be expected to arrive here in January. Vaccine orders have also been placed with other manufacturers.

Malta has agreed logistical arrangements with Pfizer to have the vaccine delivered, Fearne added.

He said the Pfizer vaccine, which was at the most advanced state of production, has to be kept at cold temperatures and will have to be transported overland.

“When the vaccine is approved, and released, the first trucks will depart to Malta. The overland journey will take between four and five days, which means that within a week the vaccine will be here and we can start vaccinating people,” he said.

The first to receive the vaccine will be the front liners dealing with sick patients and the elderly aged 80 and over.

Fearne said that Malta had ordered enough vaccines to inoculate the whole population and the nationwide roll out will take up to six months.

The vaccines on the market

News of 90% effectiveness rates in vaccine trials signals what could be the beginning of the end for the pandemic.

According to the WHO over 150 vaccines are being developed around the world. The EU has approved contracts with four companies, securing millions of doses on behalf of all member states. Contracts have been signed with AstraZeneca (the Oxford vaccine), Sanofi-GSK, Johnson & Johnson, CureVac, BioNTech-Pfizer and Moderna.

The agreements will allow all member states to purchase 160 million doses of the Moderna vaccine, 300 million doses of the AstraZeneca and Sanofi-GSK vaccines, and member states will be allowed to purchase vaccines for 200 million people from Johnson & Johnson. The EU will cover an initial purchase of 200 million doses on behalf of all EU Member States for vaccines provided by BioNTech-Pfizer, and another 225 million from CureVac.

What’s the difference?

The COVID-19 vaccines available to Malta are either genetic vaccines, protein-based, or viral vector vaccines. Genetic vaccines use part of the virus’s genetic code, either the DNA or messenger RNA cells, to trigger an immune response. The major advantage offered by these vaccines is that they can be produced more quickly than traditional methods. CureVac, Moderna and BioNTech-Pfizer are following the mRNA route to deliver the vaccine.

Sanofi-GSK are producing a protein-based vaccine using coronavirus proteins without any genetic material such as DNA or mRNA. The proteins contain engineered viruses that cultivate inside insect cells, but GSK is supplementing the protein with an adjuvant, which enhances the body’s immune response to an antigen, for added stimulation. Since a protein is not a virus, the coronavirus protein cannot cause any disease.

Viral vector vaccines use a live virus genetically engineered to carry coronavirus DNA into cells. In the case of the COVID-19 vaccine, a spike protein gene is added to an adenovirus, and the adenovirus makes its way into cells and delivers the gene. Adenoviruses are notorious for causing respiratory illnesses such as the common cold, but since the virus is missing one of its own genes the adenovirus is unable to replicate within cells, rendering the vaccine safe for use. Johnson & Johnson and Astrazeneca are using this method in their COVID-19 vaccines.

Clinical trial phases – when the vaccine will be finalized

Having finalised Phase 3 trials, the BioNTech-Pfizer is expected to be among the earliest, if not the first, to make its way to the market. The European Medicines Authority launched a rolling review of the vaccine data back in October, but the finalised data is yet to be assessed.

The Moderna vaccine was seen as another close contender to be distributed first to Malta. Phase 3 trials began back in July, and preliminary results announced on November 16 indicated a 94.5% effectiveness rate. Astrazeneca are close behind, with finished data from Phase 2/3 trials showing good efficacy.

CureVac and Sanofi-GSK lag further behind, with Phase 3 trials expected by end of year.

Vaccine effectiveness – is 90% promising?

The effectiveness rate indicates whether the vaccine is capable of preventing a person from contracting the virus. It’s important to understand that this vaccine is by no means a cure in and of itself but is instead a preventive measure to inhibit further spread of COVID-19. Any patients suffering from the virus will still have to rely on ventilators for the time being.

Regardless, a 90% effectiveness rate is a great figure for a vaccine. For comparison, the influenza vaccine has an effectiveness rate of around 60-70%. While the news sparks hope in the medical community, virologist Christopher Barbara told MaltaToday that he is “cautiously confident” in the results, emphasising that the data must first be reviewed to ensure that the figures are correct.

Compiled by Nicole Meilak

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