It takes on average over a decade to bring a conventional vaccine to market.
In early January, the only thing scientists around the world knew for sure about the new coronavirus was its genetic profile. Now, some 300 days later, vaccine developers are on the verge of a major victory against a pathogen that has inflicted untold personal and economic damage.
Virus specialists, including Anthony Fauci, America’s leading infectious disease doctor, predicted in early 2020 that it would take between a year and 18 months to develop a vaccine to deal with the contagion. Moderna Inc. and Pfizer Inc.’s collaboration with BioNTech SE is poised to beat this forecast if preliminary positive results from their vaccine trials continue.
Pfizer CEO Albert Bourla said on Tuesday the company has reached a key data security milestone and will seek emergency use authorization in the United States. The news fuels optimism about the quest to end a disease that has killed more than 1.3 million people and continues to plague.
“We are now accumulating the tools that will help us end the pandemic,” said Richard Hatchett, executive director of the Coalition for Epidemic Preparednesss Innovations, which has helped fund Moderna’s work. The favorable results do not mean that the vaccines will be immediately available on a large scale. “But, given where we are in this pandemic and where we are in the vaccine development process, you couldn’t have asked for a better outcome.”
It takes more than a decade on average for a conventional vaccine to market, and less than one in five people entering human trials reaches the finish line. A vaccine against mumps Merck & Co. developed in 1967 has the speed record: four years.
For Covid-19 vaccines, work began on January 11, less than two weeks after the notification of the first cases in China. It was then that the researchers released the genome of the coronavirus later known as SARS-CoV-2. That same Saturday, researchers at the U.S. National Institutes of Health began the first steps in developing a vaccination program that became Operation Warp Speed, according to Secretary of Health and Human Services Alex. Azar.
Moderna, in collaboration with the NIH, and Pfizer-BioNTech used the genome sequence to design a molecule called messenger RNA. When injected into cells, mRNA instructs them to make the SARS-CoV-2 spike protein, which the virus normally uses to invade cells. This key protein induces the body’s immune response.
Fast production
Vaccines using mRNA have never been licensed for use in humans, but have come into service because of how quickly they can be made. Researchers already had mRNA vaccine technology platforms, eliminating the need to create a new manufacturing process from scratch.
The production of messenger RNA vaccines is particularly rapid. It’s a chemical process that eliminates the need to grow proteins or viruses, a bottleneck that slows down the manufacturing of some other products. This meant that human testing for Moderna’s vaccine began on March 16, about two months after research began. Vaccines from Pfizer and BioNTech entered testing soon after.
“It is absolutely unprecedented to have two vaccines with very promising data from Phase 3 trials less than a year after the global emergence of a new pathogen,” HHS ‘Azar said Monday during a call with journalists.
There are still many questions that need to be answered, including how long will protection against vaccines last and how they will stand up to scrutiny by regulators. They must be manufactured and distributed to billions of people, in some cases under extreme conditions. Pfizer vaccine should be stored frozen at an ultra-low temperature -94 degrees Fahrenheit for up to a few days before use. Moderna does not have the same storage requirements.
Other technologies, like the pulled viral vector AstraZeneca Plc is developing with the University of Oxford, have also advanced rapidly, but have yet to show that they can work. The high initial efficacy rate observed with Pfizer and Moderna vaccines increases the chances of success of further injections targeting the spike protein.
“These results have just raised the tide for all boats in the port,” Hatchett of CEPI said in an interview.
Meanwhile, the central question – can you design and test vaccines against a new virus in a year – is about to be answered in the affirmative. Other Covid vaccines were developed and used in Russia and China, but before they completed the rigorous tests Pfizer and Moderna were subjected to. Russia now claims its vaccine is 92% effective based on an analysis of the first 16,000 volunteers in a large trial.
“We now know that vaccination can lead to protection,” said Seth Berkley, head of Gavi, the Vaccine Alliance, during a call with reporters after the release of Pfizer’s efficacy data. The results also show that the focus on the spike protein was deserved, he said.
Much of what made the advance possible was the money. U.S. taxpayers have contributed up to $ 18 billion for President Donald Trump’s Warp Speed program, which funds development and manufacturing. And while Pfizer hasn’t taken development funds, it has benefited from giant supply contracts from the United States and other countries that ensure a market if the vaccines are approved.
No funding could have gone anywhere without the work of scientists who have been developing techniques for making vaccines for decades. In particular, Fauci pointed out, the government has been working with Moderna for years on the development of mRNA technology.
“I think that’s one of the things the general public doesn’t fully appreciate when they hear announcements like this,” he said on Monday’s call. “They think it’s something that just happened a few months ago; it doesn’t.”
The United States Food and Drug Administration has also taken an encouraging approach, establishing a minimum efficacy of 50% in reducing Covid cases for possible vaccine clearance. This has helped drugmakers focus their large trials on achieving a clear result.
Good timing
The timing of the clinical trials turned out to be fortuitous. Pfizer and Moderna’s final trials began on July 27, in the midst of a summer forced by Covid, and received widespread media attention.
In October, both trials had tens of thousands of participants and infections in the United States were skyrocketing. Since the success of the studies depended on the build-up of a number of Covid-19 cases, the out-of-control outbreak – severe as it is for the country – has allowed trials to rack up cases and quickly produce clear results. .
Faith in science was one of the reasons Yasir Batalvi, 24, volunteered for Moderna’s Phase 3 trial. A political strategist for local campaigns in Massachusetts, Batalvi was disheartened by what he saw as vaccine misinformation.
Batalvi rolled up his sleeve for a second dose – unsure whether it would be the vaccine or a placebo – last week. Although he suffered from side effects such as fatigue and injection pain, contributing to the process was well worth it, he said.
“Researchers just want the truth, and I trust the science,” he said.
– With help from Riley Griffin.
(Except for the title, this story was not edited by GalacticGaming staff and is posted from a syndicated feed.)
