- Two coronavirus vaccine candidates failed in clinical trials, indirectly proving that the vaccine development process works.
- The measures put in place will ensure that only the drugs that are both effective and safe will be approved.
- University of Queensland and CSL agreed to stop clinical trials in Australia after researchers found the drug had an unexpected side effect: false-positive HIV diagnoses. The drug delivered a robust response against COVID-19, but a fix could take up to 12 months.
- The Sanofi/GSK drug failed to elicit an effective immune response in people older than 49. The two companies will start a new trial in February, and their new formula could be ready by the end of 2021.
Modern technology allowed hundreds of teams to start coronavirus vaccine testing in the early months of the pandemic. The early release of the SARS-CoV-2 genome was the first breakthrough that made it possible to start testing in labs right away. This led to Phase 1 clinical trials by April and Phase 3 conclusions by mid-November for the three frontrunners. While volunteers received the experimental drugs or a placebo, the companies involved in these projects started setting manufacturing and logistics in motion so that the vaccine could be distributed to those most in need as soon as regulators like the FDA issued emergency approvals.
The Pizer/BioNTech drug was approved in the UK and is expected to get a similar approval in America and the European Union. Moderna’s candidate should follow. The more controversial AstraZeneca/Oxford drug could also be approved in the coming months, although the US might need another Phase 3 trial for it. That’s the short story of the COVID-19 vaccine development history to date in Western countries. Add to that the Russian vaccine that was approved in August and the several Chinese vaccines that are already used in the wild ahead of the Phase 3 study completion, and you get the big COVID-19 vaccine picture for 2020.
But, as all of that was happening, more and more people grew anxious at the thought of getting a vaccine that was developed in record time. Fake news campaigns on social media, as well as the politicization of vaccines ahead of the US presidential election, further eroded public trust in vaccines. That can be a huge problem in the future. If not enough people get vaccinated, herd immunity can’t be reached, and the world will have to deal with the pandemic for even longer than current estimates. Western nations should return to normal by late 2021, according to experts. Herd immunity requires at least 70% of the population to be vaccinated.
Reports on Friday said that not one but two different coronavirus vaccine candidates that were in various stages of human trials failed. That might seem like bad news that can impact stock valuation and force governments who were betting on those drugs to seek additional solutions. But, strangely enough, this is also very good news for the entire coronavirus vaccine research and development process. The failure of key drugs proves to the world the research transparency that governments and pharmaceutical companies pledged. It also proves there’s intense scrutiny in this particular field and that science is the only thing that will matter when it comes to approving vaccines for public use. Those drugs and vaccines that are approved will not just be effective in COVID-19 therapy; they’ll also be safe for the general public.
The Australian government has just canceled a local coronavirus vaccine development program, as the trials showed that the vaccine interfered with HIV diagnosis. The vaccine generated antibodies that lead to false-positive HIV results. That’s obviously not the kind of response anyone would want from the vaccine.
Developed by the University of Queensland (UQ) and biotech firm CSL, the vaccine candidate elicited a “robust” immune response without serious adverse effects in a Phase 1 trial. But the UQ/CSL had to be stopped, as the drug needs to be reengineered. The process might take up to 12 months, per Reuters.
There’s still hope for the UQ/CSL project to go forward, but the main focus will be making a vaccine that can be used right now. CSL could manufacture additional doses of the Oxford vaccine to make up for the failure.
Like other Western governments, the Australian leadership inked deals with various vaccine makers, including Pfizer and Novavax. Australia secured 140 million doses for 25 million people. That’s one of the highest ratios of vaccine purchases in the world. Most vaccines will require two shots taken a few weeks apart.
A different Reuters report notes the second major vaccine failure of the week. Sanofi and GSK have announced they’re forced to delay their vaccine candidate, as the drug showed an insufficient immune response in older people. This group is most at risk of severe COVID-19 and death. Over the summer, we’ve seen health experts voicing their concerns about vaccine efficacy in the older population and those obese or overweight. Vaccines from Pfizer and Moderna have shown good efficacy across age groups.
The Sanofi/GSK drug elicited “an immune response comparable to patients who recovered from COVID-19 in adults aged 18 to 49 years, but a low immune response in older adults likely due to an insufficient concentration of the antigen” after Phase 1/2 trials.
Like with the UQ/CSL vaccine, the Sanofi/GSK vaccine project isn’t dead. The companies plan to start a new Phase 2b study in February. If successful, the trial could yield another effective vaccine by the end of 2021.
“The study will include a proposed comparison with an authorized COVID-19 vaccine,” according to Sanofi. “If data are positive, a global Phase III study could start in Q2 2021. Positive results from this study would lead to regulatory submissions in the second half of 2021, hence delaying the vaccine’s potential availability from mid-2021 to Q4 2021.”
The Sanofi vaccine uses the same recombinant protein-based tech as a Sanofi flu vaccine. GSK makes the adjuvant, which acts as a booster for the vaccine. The companies planned to manufacture up to one billion doses in 2021. GSK will continue to make the adjuvants, with some of them expected to be delivered to other partners.
While everyone was hopeful about vaccines throughout the year, there was never any guarantee these drugs would work. We don’t have vaccines for other known human coronaviruses that cause common colds. We were always facing the possibility that many vaccine candidates could fail — maybe all of them. Similarly, there’s also a possibility that the most advanced drugs will all work. Again, the UQ/CSL and Sanofi/GSK vaccine projects have not been abandoned. But these negative results should further increase confidence in the scientific process behind vaccine development and convince more people that the vaccines that are approved for emergency use are not risky political gimmicks.