Neither 12 nor 18 months: promising vaccines appear in 300 days

In early January, the only thing scientists around the world knew for sure about the novel coronavirus It was his genetic profile. Now some 300 days later, The vaccine developers are on the verge of a major victory against a pathogen that inflicts indescribable personal and financial damage.

Virus specialists, including Anthony Fauci, The main American doctor specializing in infectious diseases, predicted in early 2020 that it would take between a year and 18 months to develop a vaccine against the contagion. Moderna Inc. and Pfizer Inc. in collaboration with BioNTech SE they are on the verge of beating this prognosis, if the first positive results of their vaccine trials hold up.

The CEO of Pfizer, Albert Bourla, said on Tuesday the company has reached a key milestone in data security and will seek permission from emergency use in the United States. The news fuels optimism in efforts to stop a disease that has killed more than 1.3 million people And keep on running wild

“We are now accumulating the tools that will help us end the pandemic“, He rocks Richard hatchett, executive director of the Coalition for Epidemic Preparedness Innovations, which has helped fund Moderna’s work. The promising results do not mean that the vaccines will be immediately available on a large scale. “But given the times we are in this pandemic and the vaccine development process, I couldn’t have asked for a better outcome.”

WHO warned vaccine alone would not be enough to beat Covid

It takes more than a decade to market a conventional vaccine from the start on average, with less than one in five human trials reaching the target. The vaccine Merck & Co. against the mumps developed in 1967 has a speed record: four years.

For the covid-19 vaccines, work began on January 11, less than two weeks after the declaration of the first cases in China. It was then that researchers released the genome of the coronavirus, later known as SARS-CoV-2. That same Saturday, researchers from the National Institutes of Health (NIH) in the United States began the first steps to design a vaccination program that has become Operation Warp Speed, according to the Secretary of Health and Social 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, the 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 the speed with which they can be produced. Researchers already had technological platforms for mRNA vaccines, which Delete the need to create a new manufacturing process from scratch.

The production of messenger RNA vaccines is particularly rapid. It is a chemical process that eliminates the need to grow proteins or viruses, a bottleneck that slows down the manufacture of some other products. This meant that human testing for Moderna’s vaccine began on March 16, about two months after research began. The Pfizer and BioNTech vaccines began testing soon after.

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“It is absolutely unprecedented to have two vaccines with data highly Promising phase 3 trials less than a year after the global emergence of a new pathogen, “Azar said on a call to reporters Monday.

There are still many questions that need to be answered, including how long will vaccine protection last and how they will respond to scrutiny from regulators. They have to 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 of –70 degrees Celsius up to a few days before use. Moderna does not have the same storage requirements.

Other technologies, such as injection of viral vectors AstraZeneca Plc expands with the University of OxfordThey have also made rapid progress, but have yet to prove that they can work. The high initial efficacy rate observed with Pfizer and Moderna vaccines increases the chances of success of other advanced protein targeted vaccines.

“What these results just did was turn the tide up for all the ships in the port,” Hatchett said in an interview.

In the meantime, the central question, can we design and test vaccines against a new virus in a year? Other covid vaccines in Russia and China, but before completing the rigorous testing that Pfizer and Moderna went through. Russia now claims its vaccine is 92% effective, according to an analysis of the first 16,000 volunteers in a large trial.

“We now know that vaccination can lead to protection,” he said. Seth Berkley, head of Gavi, the Vaccine Alliance, on a call with reporters after the release of Pfizer efficacy data. The results also show that the focus on peak proteins was deserved, he said.

Vaccine diplomacy is the new ‘space race’

Much of what made this breakthrough possible was the money. The U.S. taxpayers have donated up to 18,000 million USD for President’s Warp Speed ​​Program Donald trump which funds development and manufacturing. And while Pfizer has not taken development funds, it has benefited from the gigantic supply from the United States and other countries which guarantees a market if the vaccines are approved.

None of the funds would have happened without the work of the scientists who developed vaccine manufacturing techniques for decades. In particular, Fauci noted, the US 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 ads like this,” he said on Monday’s call. “They think this is something that happened a few months ago; This was not the case “.

The United States Food and Drug Administration has also taken an encouraging approach by establishing a minimum efficiency of 50% in reducing covid cases for eventual vaccine approval. This has helped drugmakers focus their large trials on getting a clear result.

Russia: Sputnik V vaccine 92% effective and mass application begins

Great moment

The timing for the clinical trials was happy. Endgame trials Pfizer and Moderna both began on July 27, in the middle of a low-covidity summer, and received wide media attention.

In October, the two trials had tens of thousands of participants and infections in the United States skyrocketed. With the success of the studies hinging on the build-up of a number of COVID-19 cases, the out-of-control outbreak, serious as it is for the country, has allowed trials to accumulate cases and rapidly produce clear results.

Faith in science was one of the reasons why Yasir Batalvi, 24, volunteered for the Moderna Phase 3 trial. Batalvi, a political strategist for local campaigns in Massachusetts, was put off by what he saw as vaccine misinformation.

Batalvi rolled up his sleeves for a second dose, unsure whether it would be the vaccine or a placebo, last week. Although she suffered from side effects like fatigue and pain from the injection, it was worth contributing to the process, she says.

“Researchers just want the truth and I trust the science,” he says.

EuDr / DS