After final trial results showed it had a 95 percent success rate and no severe side effects, Pfizer and BioNTech could secure emergency US and European authorization for their COVID-19 vaccine next month, the drugmakers said.
The efficacy of the vaccine has been found to be consistent across different ages and ethnicities which is a positive indication, as the elderly and some communities, including Black people, have suffered disproportionately because of the disease.
BioNTech Chief Executive Ugur Sahin said the US Food and Drug Administration (FDA) could grant emergency use approval by mid-December. It is possible to secure conditional European Union approval in the second half of December, he added.
“If all goes well I could imagine that we gain approval in the second half of December and start deliveries before Christmas, but really only if all goes positively,” he said.
The success rate of the vaccine developed by the US drug company and German partner BioNTech was much higher than what would have been acceptable for regulators. Experts said it was a significant achievement in the race to end the pandemic.
In Pfizer’s study involving over 43,000 participants, 162 of the 170 volunteers who contracted COVID-19 received a placebo (a substance or treatment which is designed to have no therapeutic value) and not the vaccine, meaning the vaccine was 95 percent successful. Of the 10 individuals who had serious COVID-19, only one was vaccinated.
BioNTech’s Mr. Sahin said US emergency use authorization (EUA) would be applied for on 20th November.
The final review of the trial comes a week after initial findings showed that the vaccine was more than 90% effective. Recently, another US drugmaker Moderna published preliminary data for its vaccine that showed 94.5 percent efficacy.
US officials said that the Moderna vaccine is likely to be approved within 7 to 10 days after Pfizer receives its EUA (Emergency Use Approval), with states ready to start distribution within 24 hours.
Both developed with advanced messenger RNA (mRNA) technology, the better-than-expected outcomes of the two vaccines have boosted expectations for an end to a pandemic that killed more than 1.3 million people and wreaked havoc on economies and everyday life. With the virus again running rampant across the world, setting records for new infections and hospitalizations almost daily, the news is especially positive.
In individuals over age 65, a particularly high-risk group, the Pfizer-BioNTech shot was found to have 94 percent efficacy.
Vaccine production has been viewed by global investors as a competition between companies, while there is likely to be global demand for as much vaccine as can be developed in the near future.
Pfizer said it plans to produce as many as 50 million doses of vaccine this year, enough to safeguard 25 million people and then generate up to 1.3 billion doses in 2021.
While some groups such as healthcare workers will be prioritized for vaccinations, it will be months before large-scale roll-outs begin in countries.
Pfizer said that it had offered to send millions of doses to Brazil in the first half of 2021. Agreements with the European Union, Germany and Japan are already in place and distribution could begin next year.
The World Health Organization’s (WHO) top emergency expert, Mike Ryan, said it would be at least 4-6 months before there are significant levels of vaccination across the globe.
The need to store it at ultra-cold temperatures of -70 degrees Celsius complicates the distribution of a Pfizer-BioNTech shot. However it can be kept in regular refrigeration for up to five days or in a thermal shipping box for up to 15 days.
Moderna vaccine can be stored at -20 degree Celsius for up to six months and it is expected to be stable at normal refrigerator temperatures of 2 to 8 degrees Celsius (36 °-46 °F) for 30 days.
Pfizer vaccine’s side effects
Pfizer stated that the vaccine was well-tolerated and that the side effects were mainly mild to moderate and cleared up easily. After the second dose, the only significant adverse events suffered by volunteers were nausea (3.8 percent) and headaches (2 percent). Older adults tended to report fewer and milder adverse events.
“These are extraordinary results, and the safety data look good,” say vaccine experts.
From among the dozens of drugmakers and research groups rushing to develop COVID-19 vaccines the next late-stage data is likely to be from AstraZeneca, who is working with the University of Oxford, in November or December. Johnson & Johnson said it is on track to deliver data this year.
It will take longer to authorize vaccines for children. Only Pfizer has begun vaccinating volunteers between the age groups of 12 to 18. Moderna and J&J said they intend to begin testing the vaccine in younger individuals soon.