Phase 3 Testing Results in the Coming Weeks
Oxford expects to have the early results from the final stage over the next several weeks. The research group was also conducting tests to determine whether the vaccine prevents people from developing the virus in phase 3 trials.
The government in the United Kingdom has ordered 100 million doses of the Oxford vaccine, 40 million doses of the vaccine developed by Pfizer and BioNTech vaccine, and 5 million doses of the Moderna vaccine.
Oxford Vaccine Trial Chief Investigator Andrew Pollard said he was "absolutely delighted with the results" producing promising immune response "even in those over 70 years of age."
When asked whether the vaccine protects against the virus, Pollard said they were "not there yet," but he expects the data to be released ahead of Christmas. He emphasized that there should be no competition with other vaccine developers and that we need other vaccines to be successful as well.
"We will need all of them to protect people around the globe," Pollard said.
So far, three vaccines by Pfizer-BioNTech, Sputnik, and Moderna have delivered outstanding preliminary data from the final stage of trials. The aim of developing the coronavirus vaccine is to stimulate the human body to fight the virus. This means that older people’s immune systems may not react as successfully as younger people’s.
Fortunately, Oxford’s latest trials indicated that their vaccine might resolve that issue as older adults aged 56 and over had a similar response to younger people aged between 18 and 55.
"We were pleased to see that our vaccine was not only well-tolerated in older adults, but also stimulated similar immune responses to those seen in younger volunteers,” said Dr. Maheshi Ramasamy, an investigator at the Oxford Vaccine Group.
"The next step will be to see if this translates into protection from the disease itself."
Over 99% of volunteers of all ages produced neutralizing antibody responses about two weeks after receiving the second dose.
The T-cell response reached its peak two weeks after the participants received the first dose. Dr. Ramasamy said strong antibody and T-cell responses among older people were “encouraging.”
"The populations at greatest risk of serious COVID-19 disease include people with existing health conditions and older adults. We hope that this means our vaccine will help to protect some of the most vulnerable people in society, but further research will be needed before we can be sure."
Final Phase 3 Data From Pfizer and BioNTech Presented
The US drugmaker Pfizer and Germany’s BioNTech said they could get regulatory approval in the States and Europe for their coronavirus vaccine as soon as next month after their trial results produced a 95% efficacy rate and no significant side effects.
Pfizer’s and BioNTech’s vaccine displayed similar results for all ages and ethnicities — an encouraging indicator as the virus has affected older and Black people more than other groups.
Ugur Sahin, CEO of BioNTech, said the US Food and Drug Administration could approve emergency usage by the middle of December, while the conditional approval in the European Union could be expected in the second half of December.
"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," Sahin said.
Scientists said the results achieved by Pfizer and BioNTech represented a major step for ending the pandemic and have been significantly higher than what regulators consider to be acceptable.
Sahin added that the drugmakers would apply for the US emergency use authorization (EUA) on Friday. The FDA advisory committee tentatively is expected to hold a meeting between December 8 and December 10 to talk about the vaccine, though the dates could vary given the emergency situation related to COVID-19.
According to the latest data, the coronavirus vaccine developed by Oxford produced a robust immune response among older adult groups in their 60s and 70s. In more positive news, Pfizer and BioNTech said they could get the approval for emergency use for their vaccine by mid-December.