Drug makers Pfizer and BioNTech’s Covid-19 vaccine could secure emergency US and European authorisation next month after final trial results showed a 95% success rate with no serious side effects.
The US Food and Drug Administration (FDA) could grant emergency-use by the middle of December, and conditional approval in the European Union could be secured in the second half of December, BioNTech Chief Executive Ugur Sahin told Reuters TV.
The success rate of the vaccine developed by Pfizer-BioNTech was far higher than what regulators had said would have been acceptable. Experts said it was a significant achievement in the race to end the pandemic.
The vaccine’s effectiveness was found to be consistent across different ages and ethnicities. Out of the 170 volunteers who contracted the virus in Pfizer’s trial involving over 43,000 people, 162 had received a placebo and not the vaccine, meaning the vaccine was 95% effective. Of the 10 people who had severe Covid-19, one had received the vaccine.
According to Enrico Bucci, a biologist at Temple University in Philadelphia., it is a first in the history of mankind; less than a year from the sequence of the virus to the large-scale clinical trial of a vaccine, moreover based on a whole new technique.
The final trial analysis comes a week after initial results showed the vaccine was more than 90% effective. Moderna Inc also released preliminary data for its vaccine showing 94.5% effectiveness.
In a statement by US Health and Human Services Secretary Alex Azar, he said there are now two safe and highly effective vaccines that could be authorised by the Food and Drug Administration and ready to distribute within weeks.
The Moderna vaccine is likely to be authorised within 7-10 days of Pfizer receiving its EUA, US officials said, with states ready to begin distribution within 24 hours
The amazing results from the two vaccines, both developed with new messenger RNA (mRNA) technology, have raised hopes for an end to a pandemic that has killed more than 1.3 million people and ravaged global economies and ruined daily life.
It is a welcoming news as the virus is again running rampant around the world, setting records for new infections and hospitalisations almost daily.
Investors have treated vaccine development as a race between companies, although there is likely to be global demand for as much vaccine as can be produced for the foreseeable future.
Pfizer said it expects to make as many as 50 million vaccine doses this year, enough to protect 25 million people, and then produce up to 1.3 billion doses in 2021.
According to Mike Ryan, the World Health Organization’s top emergency expert, it would be at least 4-6 months before significant levels of vaccination were taking place around the world.
Distribution of a Pfizer-BioNTech shot is more complex as it needs to store at ultra-cold temperatures of -70 degrees Celsius. It can, however, be kept in normal refrigeration for up to five days, or up to 15 days in a thermal shipping box.
Moderna’s vaccine can be stored for up to six months at -20 degrees Celsius though it is expected to be stable for 30 days at normal fridge temperatures of 2 to 8 degrees Celsius.
Of the dozens of drugmakers and research groups racing to develop the vaccines, the next late-stage data will likely be from AstraZeneca Plc with the University of Oxford in November or December. Johnson & Johnson said it is on track to deliver data this year.
Authorization of vaccines for children will take longer. Only Pfizer has started vaccinating volunteers under age 18 and as young as 12. Moderna and J&J have said they hope to start testing the vaccine in younger people soon.