New vaccine gives hope in fight against pandemic
The Moderna vaccine is 94.5% effective against coronavirus, according to early data released Monday by the company, making it the second vaccine in the United States to have a stunningly high success rate.
“These are obviously very exciting results,” said Dr Anthony Fauci, the nation’s top infectious disease doctor. “It’s just as good as it gets — 94.5% is truly outstanding.”
Moderna heard its results on a call Sunday afternoon with members of the Data Safety and Monitoring Board, an independent panel analyzing Moderna’s clinical trial data.
“It was one of the greatest moments in my life and my career. It is absolutely amazing to be able to develop this vaccine and see the ability to prevent symptomatic disease with such high efficacy,” said Dr Tal Zacks, Moderna’s chief medical officer.
Vaccinations could begin in the second half of December, Fauci said. Vaccinations are expected to begin with high-risk groups and to be available for the rest of the population next spring.
Moderna shipped the first batches of a vaccine to the NIH on February 24, just 42 days after it received the virus’ genetic sequence. At the time it stated it will take at least 12 to 18 months to know if Moderna’s vaccine — or any others — is safe and effective, though Moderna is working to compress that timeline as much as it can. The company has said the vaccine could be ready for emergency use by this winter.
In July, researchers published the first results from testing the vaccine in people. A small study of 45 healthy volunteers, focused on evaluating the safety of the vaccine, found that the vaccine generated an immune response in all of the participants. Now, Moderna is planning to start a 30,000-person trial to find out if the vaccine works to prevent the coronavirus.
The journey shows how, under the brightest possible spotlight, Moderna is challenging the lengthy and costly process of vaccine development. The company has never before brought a vaccine to market, and a victory would help establish its technology as a new medical innovation and save lives.
Unexpectedly high efficacy rates
Last week, Pfizer announced that early data show its vaccine is more than 90% effective against the disease.
In Moderna’s trial, 15,000 study participants were given a placebo, which is a shot of saline that has no effect. Over several months, 90 of them developed Covid-19, with 11 developing severe forms of the disease.
Another 15,000 participants were given the vaccine, and only five of them developed Covid-19. None of the five became severely ill.
The company says its vaccine did not have any serious side effects. A small percentage of those who received it experienced symptoms such as body aches and headaches.
Moderna plans to apply to the US Food and Drug Administration for authorization of its vaccine soon after it accumulates more safety data later this month.
Fauci says he expects the first Covid-19 vaccinations to begin “towards the latter part of December, rather than the early part of December.”
Initially, there won’t be enough vaccine for everyone. The highest priority groups, which include health care workers, the elderly, and people with underlying medical conditions, will get the vaccine first.
“I think that everybody else will start to get vaccinated towards the end of April,” Fauci said. “And that will go into May, June, July. It will take a couple of months to do.”
A new vaccine technology
Pfizer’s and Moderna’s vaccines have similar results because they use the same technique to activate the body’s immune system.
The vaccines deliver messenger RNA, or mRNA, which is a genetic recipe for making the spikes that sit atop the coronavirus. Once injected, the body’s immune system makes antibodies to the spikes.
If a vaccinated person is later exposed to the coronavirus, those antibodies should stand at the ready to attack the virus.
No vaccine currently on the market uses mRNA.
“There has always been scepticism about mRNA — it’s brand new and would it work?” Fauci said. “What we saw in the trials is there was no real safety concern, and the efficacy is quite impressive. We saw nearly identical results [with Pfizer and Moderna] and it almost really validates the mRNA platform.”
Research on mRNA began many years before the current pandemic. Fauci’s agency, the National Institute of Allergy and Infectious Diseases has collaborated with Moderna on the development of its vaccine.
Both vaccines are given in two doses several weeks apart.
Practical advantages of Moderna’s vaccine
While the two vaccines appear to have very similar safety and efficacy profiles, Moderna’s vaccine has a significant practical advantage over Pfizer’s.
Pfizer’s vaccine has to be kept at minus 75 degrees Celsius. No other vaccine in the US needs to be kept that cold, and doctors’ offices and pharmacies do not have freezers that go that low.
Moderna’s vaccine can be kept at minus 20 degrees Celsius. Other vaccines, such as the one against chickenpox, need to be kept at that temperature.
That means Moderna’s vaccine can be kept in “a readily available freezer that is available in most doctors’ offices and pharmacies,” Zacks said. “We leverage infrastructure that already exists for other marketed vaccines.”
Another advantage of Moderna’s vaccine is that it can be kept for 30 days in the refrigerator, the company announced Monday. Pfizer’s vaccine can last only five days in the refrigerator.
The big picture: The Moderna vaccine was part of the federal government’s Operation Warp Speed acceleration project, and the company received about $2.5 billion to back its research and development.
- Pfizer, on the other hand, funded its own vaccine research but did commit to an Operation Warp Speed deal to speed potential distribution.
Worth noting: Like Pfizer’s announcement last week, Moderna’s details on its vaccine candidate came in the form of a press release.
- The data has not been peer-reviewed and its effectiveness could change as the study progresses.
- Pfizer CEO Albert Bourla said that his company had avoided such specificity about effectiveness given that the numbers could continue changing as its trial continues.
Both vaccines use the same approach of injecting part of the virus’s genetic code in order to provoke an immune response.
The preliminary data we have seen so far is very similar – around 90% protection for the Pfizer/BioNTech vaccine and around 95% for Moderna’s.
However, both trials are still taking place and the final numbers could change.
Moderna’s vaccine appears to be easier to store as it remains stable at minus 20C for up to six months and can be kept in a standard fridge for up to a month.
Pfizer’s vaccine needs ultra-cold storage at around minus 75C, but it can be kept in the fridge for five days.
The Sputnik V vaccine, developed in Russia, has also released very early data which suggests it is 92% effective.
So far, the UK government has secured access to six candidate vaccines, which includes the Pfizer vaccine but not the Moderna vaccine.
“As part of the ongoing work of the vaccines taskforce, the government is in advanced discussions with Moderna to ensure UK access to their vaccine as part of the wider UK portfolio.
“Moderna are currently scaling up their European supply chain which means these doses would become available in spring 2021 in the UK at the earliest.
“To date, the UK government has secured early access to 350 million vaccines doses through agreements with six separate vaccine developers.
“This includes 40m doses of Pfizer/BioNTech’s vaccine, which is based on the same platform as Moderna’s vaccine and if approved by the medicines regulator, is expected to begin delivery as early as December 2020.”
The US government have an agreement for 100 million doses of the Moderna vaccine, while the EU concluded “exploratory talks” with the company earlier this year that could result in it purchasing up to 160 million doses.