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  /  Covid   /  Pfizer and BioNTech ‘s COVID Vaccine Passed Phase 3 Trials
human trials pfizer bioNTech vaccine covid 19

Pfizer and BioNTech ‘s COVID Vaccine Passed Phase 3 Trials

The Vaccine has cleared Phase 3 of Human Trials, Now what?

It has been a common yet hot discussion topic about the earliest availability of drugs and vaccines that can fight the deadly coronavirus. But finding a cure is not easy as it involves plenty of compound screening, extensive research, compound synthesis, and prolonged trials. Thanks to artificial intelligence, machine learning, and high computational processors, and data analytics, the search time for a drug can be reduced. However, human trials are one aspect that can’t be sped up. But fortunately, Pfizer and its German partner BioNTech announced vaccine candidate against covid-19 achieved success in the first interim analysis from the Phase 3 study.

The Phase 3 clinical trial of BNT162b2 began on July 27 and has enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the vaccine candidate as of November 8, 2020. It has so far proven to be safe, raising hope that the pandemic could be brought under control by the summer of next year. Though the main challenge next will be that the vaccine supplies are likely to be limited until well into 2021, meaning most people won’t be able to get it anytime soon. As per an article in the Wall Street Journal, the company believes it can seek authorization to sell the vaccine sometime this month, although regulators will have to review the data. Another issue is the maintenance of the cold chain. It is evident that vaccines are fragile products. They need to be stored at specific temperatures, and some are sensitive to light and need to be transported in dark glass vials. These precise conditions must be maintained throughout the vaccine journey until they can be taken out for immunization.

It has since been suggested that the NHS could begin vaccinating people from the beginning of next month if the vaccine receives approval – although Boris Johnson has been more cautious in welcoming the possible breakthrough. Further, submission for Emergency Use Authorization (EUA) to the US Food and Drug Administration (FDA) has been planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November.

For addressing the temperature concern, special GPS trackers will be used to remotely monitor the Pfizer/BioNTech vaccine’s temperature to ensure it stays at the correct heat to keep it effective. The technology relies on synthetic mRNA to activate the immune system against the virus, which must be kept at -70C. Pfizer has designed a suitcase-sized container that will keep the doses at -70C for up to 10 days using dry ice. Here, each container will hold around 1,000 doses. Next, the shipping vessels or transport vehicles will be fitted with thermal sensors to enable the pharmaceutical giant to track the location and temperature of the frozen vaccine vials. And once the vaccine has been transported, it can be stored in a fridge for up to five days at 2-8C. This is entirely feasible in a standard medicine fridge at a GP practice. The Pfizer storage units can also be refilled with ice for up to 15 days. However, the vaccine shots will spoil in around five days at normal refrigeration temperatures of slightly above freezing, thus creating a bottleneck for mass campaigns.

“The cold chain is going to be one of the most challenging aspects of the delivery of this vaccination,” said Amesh Adalja, senior scholar at Johns Hopkins Center for Health Security. Meanwhile, the vaccines developed by Johnson & Johnson and Novavax Inc can be stored at 2C to 8C, which is a regular refrigerator temperature. BioNTech CEO Ugur Sahin told Reuters the companies are analyzing if they can extend that for two weeks.

According to an article published on NYTimes, half of the participants received two doses of the vaccine three weeks apart, and half received a placebo. The first analysis was based on 94 volunteers who developed Covid-19. To calculate the efficacy rate, the independent board of experts compared how many of those 94 cases were in the placebo group and how many were in the vaccinated group. (If all 94 had been in the placebo group, for example, the vaccine would be considered 100 percent effective.) Though the outside board did not disclose how many of those cases came from each group. But with a rate of more than 90 percent effectiveness, most had to have been in the placebo group.

Italy will receive 40 million doses, while Spain expects to receive 20 million doses from the US pharmaceutical giant to immunize up to 10 million people “for free” by December or early 2021, as stated by Spanish Minister of Health Salvador Illa on Tuesday.  Australia has only secured enough for five million people. However, it has also secured separate deals with other vaccine developers, viz., AstraZeneca/Oxford University, the University of Queensland, and Novavax. Earlier, the UK government has ordered 40 million doses of the Pfizer candidate, 10 million of which are due to be delivered by the end of the year if approval is granted. Further, Pfizer and BioNTech have a £1.48bn contract with the US government to deliver 100 million vaccine doses beginning this year. Along with the US, the two firms have also reached supply agreements with the European Union, Canada, and Japan.