Yogi Berra is ignorant of Covid-19 – he passed away 5 years ago – but his quotes apply to the development of the Covid-19 vaccine.
Over the past six months, pharmaceutical companies have made different predictions about the timeline of their Covid-19 vaccination but it turned out to be incorrect.
In a recent example, Pfizer said for weeks it would know by the end of October if their vaccine was working – but on Tuesday during an investor call, the company’s CEO that has essentially ruled out.
While Pfizer and other companies sometimes make their statements, other times they are more definitive about their predictions.
Scientists say that will guide us as we get closer to vaccines: Don̵7;t believe what you hear, because the famous vaccine testing and production is unpredictable. .
Dr Nelson Michael, a vaccine expert in the Army who has worked on 20 vaccine clinical trials, said: “Unexpected things always happen in the development of vaccines. “There are a lot of puzzles and it’s important to understand that.”
While health officials also make forward-looking statements, they are often more ambiguous than pharmaceutical companies.
Dr Paul Offit, a member of the US Food and Drug Administration’s vaccine advisory committee, said it would be wise for pharmaceutical companies to stop making forecasts about their timelines. .
“Companies should stop making predictions, because the nature is very humble,” said Offit.
Announcing the ‘near perfect’ vaccine
The scientists interviewed for this story shuddered at the thought of describing a vaccine as “near perfect” when it has not been fully studied in large-scale trials. The Pfizer vaccines, like the other three, are still in the 3rd clinical trial phase in the US and no one knows if they will work – let alone near completion.
The vaccine from Pfizer and another pharmaceutical company, Moderna, uses a new technology in its Covid-19 vaccine – no vaccine on the market yet uses it.
Offit says being alone is a reason to be cautious.
“This virus has been around for less than a year and it caused a lot of clinical findings that we had never predicted, and now we are going to deal with it with an unknown vaccine. commercial experience? here? ” Offit, a member of the FDA’s Advisory Committee on Vaccines and Biological Products, said.
According to a statement by BioNTech sent to CNN, Sahin’s comment “is based on preliminary reactions of antibodies and T cells and the favorable safety profile observed in the study to date.” that need to wait for data on efficiency that are not available.
The Pfizer CEO has made a clear timing prediction whether a vaccine will work or not.
But during an investor call on Tuesday – just five days before the end of the month – Bourla said the company has yet to see its vaccine data. Pfizer’s first chance to see that data will be when 32 people in its trial become ill with Covid-19 – and Bourla tells investors this hasn’t happened yet.
Accessing those 32 coronavirus cases still won’t give the company the necessary data. Bourla told investors it would need an independent panel of experts to analyze those cases – and that could take at least a week. That means the data cannot arrive in October, as Bourla predicted.
CNN has reached out to Pfizer for response.
“I don’t believe our CEO or we’ve said that the world will definitely expect an announcement by the end of the month. Instead, it’s likely we’ll know about the effectiveness by the end of the month. exchange, “according to a company spokesman.
Predictions from Oxford University for the September results
Pfizer is not the only company making predictions that may or may not come to fruition.
In May, CNN asked Oxford researcher Dr. Adrian Hill when the university trial would end.
“I guess July will be fine. Most likely August. Maybe September,” he said. “We are aiming for September but hope to be done by that.”
September comes and goes. Even now, Oxford’s Phase 3 trial is still underway.
“We have seen with this pandemic that fluctuating rates of spread and transmission make them difficult to predict, and that critical measures to control cases, such as the UK government door lock, have done so. slow transmission, “an Oxford spokesperson wrote in an email to CNN. “We have always insisted that if transmission remains high, we can get enough data for a few months to see if the vaccine is working, but if transmission drops, the This may take longer. “
Viruses – and vaccines – are unpredictable
The spread of the virus is unpredictable – and vaccine experts say that’s exactly why pharmaceutical companies should avoid making predictions.
In the Phase 3 trial, pharmaceutical companies vaccinated study participants and then found themselves infected in everyday life. As the virus rate drops, fewer participants will be infected, which slows down the trial process.
Even after clinical trials are complete, manufacturing problems may occur. This is true for many vaccines and may also be true for Covid-19 vaccine.
“People weren’t thinking about production, but manufacturing killed a lot of the product,” said Norman Baylor, former director of FDA’s Office of Vaccine Research and Evaluation.
Medicines often use chemicals, but vaccines deal with increasing living matter, not always going as planned.
“It’s wild and crazier when it comes to living systems,” says Baylor. “Making vaccines is like cooking. A recipe may work one day, not the next.”
That is why vaccine experts say the best plans may fail.
“The best scenario never happens,” said Michael, director of the Infectious Diseases Research Center of the Army Research Institute Walter Reed. “Inflammation and warts occurred during vaccine development.
Or to quote Berra again, “it’s not over until it’s over.”
CNN Health’s John Bonifield and Sierra Jenkins contributed to this story.