- The only coronavirus vaccine candidate that still has a chance of being approved for emergency use by election day is being fast-tracked in Europe as well.
- Moderna and AstraZeneca face a few delays and setbacks in the US, making approvals by November 3rd highly unlikely.
- Pfizer and BioNTech said in the past they might be ready to seek emergency approval in the US. The EU is now in the process of fast-tracking the Pfizer vaccine.
Coronavirus vaccine research advanced at tremendous speed this year, fueled by worldwide interest in developing the drug that might end the pandemic. Hundreds of candidates have been announced, and about a dozen of them have reached the final testing stage. But as vaccines entered the key Phase 3 of research, they became incredibly politicized. Competition between countries prompted Russia to launch a vaccine for public use in August, a controversial move given the experimental drug’s lack of data. Multiple reports from China indicated that several of the country’s vaccines in the final stage of testing were given to the public. Unlike Russia, China provided a steady stream of research that detailed its experimental drugs’ efficacy and safety. Simultaneously, the Trump administration turned vaccines into a political weapon, with some experts worrying that Trump would pressure the FDA to approve one of the three frontrunners in time for the presidential election.
FDA officials and Dr. Anthony Fauci pushed back, stressing that vaccine research would not bypass safety rigors. Separately, several of the leading vaccine developers signed a pledge not to skirt safety and respect the scientific process. Two of the three leading drugs that had a chance of being approved for emergency use in America by November 3rd seem to be out of the race. It’s unclear whether the third one has a chance to reach regulatory approval by the end of November, but the European Union is fast-tracking the same experimental drug.
Moderna was the first US company to start coronavirus trials, and one of the first biotech firms in the world to kick Phase 1 testing. It also reached Phase 3 faster than competitors, and it signaled back in spring that emergency approval could be obtained this fall. The company had to revise its estimates a few days ago, indicating that any emergency use approval would come only after the presidential election. Moderna expects its vaccine to be available to the public only several months into 2021.
The AstraZeneca/Oxford vaccine also had an ambitious schedule initially, but Phase 3 trials were halted worldwide in early September after an unexpected incident. The trial resumed in the UK and elsewhere, but the FDA paused the US arm of the research. Reports in early September suggested that the Trump administration would fast track the Oxford vaccine.
Pfizer and BioNTech have the third leading coronavirus vaccine when it comes to the research timeline. That’s the only vaccine that might have early data for Phase 3 in time for the presidential election, given the developments above. And it’s the vaccine candidate that the EU is fast-tracking.
The European Medicines Agency has accelerated the drug’s approval process so that rapid authorization is ready once the safety data is available, reports The Financial Times.
Preliminary results from the previous stages of testing convinced regulators to fast-track the approval process. Pfizer and BioNTech said the accelerated approval process would not affect safety standards.
“It is our duty to ensure that while we are working to develop a vaccine at unprecedented speed to help break this pandemic, we do so with the highest ethical standards while adhering to sound scientific principles,” BioNTech cofounder Ugur Sahin said.
The Pfizer/BioNTech vaccine is actually the second experimental COVID-19 drug to be fast-tracked for approval in the EU, after AstraZeneca’s Oxford drug.
Pfizer has said it could receive emergency use authorization in the US in October, although it’s yet to make any announcements. Approval for emergency use would allow governments to move forward with immunization campaigns targeting specific at-risk categories, including the elderly and frontline workers.
The US government has already inked deals worth billions of dollars with Moderna, AstraZeneca, and Pfizer to secure hundreds of millions of doses. But the vaccines would only be delivered if they’re approved for public use. They’d have to meet efficacy and safety requirements first, via the ample Phase 3 tests.
Multiple vaccines will be needed to satisfy worldwide demand, especially considering that most of these advanced drugs come with a two-dose regimen. The two shots are given a few weeks apart.
Pfizer and BioNTech hope to manufacture 1.3 billion doses in 2021, and up to 100 million doses this year. The EU is looking to secure 200 million doses. The US government placed an initial order of 100 million doses, with an option of purchasing an additional 500 million.