On Wednesday, the UK became the 1st western country to get the licence for COVID-19 vaccine as health regulators cleared the Pfizer and BioNTech vaccine.

The two-shot mRNA vaccine BNT162b2 got a temporary authorization for emergency use by the Medicines and Healthcare Products Regulatory Agency (MHRA). This approval is ahead of decisions by Europe and the US.

Pfizer CEO Albert Bourla said that the Emergency Use Authorization (EUA) in the UK has marked a historic moment in the battle against COVID-19. It is trulya historic moment as it is developed in record time and is also the first vaccine that is based on messenger RNA or mRNA technology which is approved for human use.

The COVID-19 mRNA vaccine, when once injected, shall give instructions to the cells to create a harmless piece called the “spike protein.” After the protein piece is made, the cell will break down the instructions and get rid of them. The human immune system will recognize that the protein doesn’t belong there and thus will start building an immune response and produce antibodies, same as what happens in natural infection against COVID-19.

No commercially available vaccine or drugs has used this platform and has never tested on large-scale human trials until now. Moderna’s mRNA 1273 claims to be 94.1% effective in preventing coronavirus infection and is also based on the same technology. The company has requested the EUA for the same.

Emergency use authorization (EUA) enables temporary approval to a medical product in an emergency situation such as the coronavirus pandemic if there is enough evidence suggesting its efficacy and safety. The final approval is granted only when the trials and analysis of the full data are completed. Until then, the EUA allows the medicinal product or the vaccine to be used on the public.

For COVID vaccines, the Food and Drug Administration (FDA) stated that it will consider an application for EUA only if the phase 3 clinical trials evidence showed at least 50% efficacy in preventing the infection.

The US pharma giant Pfizer and its German biotech partner had announced the final data analysis of the late-stage trial in November, which was found that the vaccine was 95% effective. The final analysis assessed 170 confirmed COVID infections in 43,661 participants, out of them 162 cases of COVID were seen in the placebo group versus only 8 cases were observed in the group receiving the two-dose vaccine. Pfizer stated that there were no serious safety concerns associated with the vaccine. The only severe side effect occurred in more than 2% of people was fatigue and in 3.7% of patients after the second dose along with headache, which was observed in 2%.

The Pfizer-BioNTech vaccine should be stored and transported at about -70C, which is a major challenge. Addressing the concerns that were raised on maintaining the cold temperatures required to guarantee the quality of vaccine, it said that companies have developed special, temperature-controlled shippers for the BNT162b2 vaccine candidate that can maintain the required storage conditions (-70°C ±10°C) for prolonged periods of time without any additional equipment but only dry ice. The shipper can maintain temperature for almost 10 days unopened allowing transportation to markets globally. Once it is open, a vaccination centre might use the specially designed shippers as a temporary storage to maintain the suggested storage conditions (-70°C ±10°C) up to 30 days with re-icing every 5th day in accord with the handling instructions. Each shipper has a GPS-enabled thermal sensor to track the location and temperature of each shipment of vaccine 24 hours a day and 7 days a week. Once it is thawed, the vaccine vial can be stored for five days at refrigerated (2-8°C) conditions.

The first doses of the vaccine are projected to arrive in the UK in the upcoming days. Pfizer and BioNTech has an agreement with the UK, will supply 40 million doses and the delivery will occur throughout 2020-2021.

Source: ET Healthworld