Explained: Is Moderna's vaccine for COVID-19 worth the hype?

On January 12, within three days after Chinese authorities shared the genetic sequence of the novel coronavirus, an infectious disease research team at Moderna Therapeutics, along with experts at the National Institutes of Health (NIH), finalised the sequence for mRNA-1273.

The mRNA-1273 is Moderna's vaccine candidate against COVID-19. Things moved swiftly thereafter.

Early this week, the Massachusetts-based biotech company announced positive interim phase-1 or early stage clinical trial data. Moderna's market valuation soared to $29 billion. Its stock was trading at $20 on Nasdaq on January 12 and hit $80 on May 18 when it announced the interim data.

It took just 63 days, for the potential vaccine to move from the stage of sequence to dosing the first human participant. Usually, it takes six months.

Interestingly the company is yet to commercially launch a single vaccine or drug. That is not the only reason why Moderna's work has caught everyone's fascination.

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What does data tell us about Moderna vaccine?

Experts say what the company revealed was very little information and warn people to take the data with a pinch of salt.

Either Moderna, or the National Institute of Allergy and Infectious Diseases (NIAID) - a part of NIH which is conducting the trial, has to publish the data in any scientific journal.

Instead, we have to rely on the company's press statement. The company said eight participants across the 25 µg and 100 µg dose had produced antibodies against SARS-CoV-2. It added that the levels of neutralizing antibodies at day 43 were at or above levels generally seen in serum of the patients who have recovered from COVID-19.

The company said mRNA-1273 was generally safe and well tolerated. The mRNA-1273 provided full protection against viral replication in the lungs in a mouse challenge model

Several unanswered questions

According to a Stat report, the company disclosed results from only eight of the 45 participants. The status of the remaining participants is unknown. There were also questions about how good these neutralising antibodies are against COVID-19 and how long they would last in our body to provide protection against the COVID-19 infection.

But, then, why is the Moderna vaccine getting so much attention?

Moderna vaccine is ahead of the race. In addition, it is novel technology, and the US government is backing it. The US government is supporting the Moderna vaccine both for clinical trial and funding. The current human trial is done jointly by NIAID, headed by Anthony Fauci. Fauci is a prominent member of the White House’s coronavirus task force of NIH.

Moderna also raised plenty of money, with the Biomedical Advanced Research and Development Authority (BARDA) of the US government recently giving it around $483 million. The first clinical batch was funded by the Coalition for Epidemic Preparedness Innovations. CEPI was founded in Davos by the governments of Norway and India, the Bill & Melinda Gates Foundation, the Wellcome Trust, and the World Economic Forum.

Why is the science behind Moderna's vaccine fascinating?

Moderna's mRNA vaccine is novel in its approach. The vaccines that are in the market now contain weakened or inactivated disease causing viruses or proteins related to the virus called antigens, which work by mimicking the infectious virus. Once the vaccine is injected it activates the body’s immune system, and issues instructions to produce antibodies.

The mRNA or messenger RNA vaccine sends a genetic code to the cell to produce the protein of its choice. In this case - the Moderna's mRNA vaccine tells the cell to produce SARS-CoV-2 spike protein. The protein stimulates the immune system. Unlike a conventional vaccine where the virus strain or its protein has to be injected into the body, mRNA vaccine uses our own cells as factories to produce vaccines.

Benefit of mRNA vaccine?

The conventional vaccines are complex to produce. The organism or the protein of choice has to be cloned first. Then it requires chicken eggs or other mammalian cells to grow the virus and then purified. All this is time-consuming and expensive. The advantage of mNRA method is that it helps to develop and produce vaccines rapidly at scale, especially crucial given the backdrop of COVID-19 pandemic. RNA based vaccines are safer for the patient, as they don't use any live or inactivated viruses, and secondly they get destroyed once the protein is made, and doesn't integrate into the host genome.

It isn't COVID-19 alone, mRNA method is now used to develop vaccines against other infectious diseases, cancers and heart diseases. Moderna currently has nine mRNA vaccines in the development pipeline, with seven undergoing Phase 1 studies.

To be sure it isn't Moderna alone that's developing mRNA vaccines, two German biotechs CureVac and BioNTech are also developing vaccines for COVID-19. BioNTech has a partnership with pharma giant Pfizer.

Challenges involved in mRNA vaccine

For years, Moderna has been stealthily developing mRNA therapies. The secrecy often led to skepticism of its technology, but investors kept pouring billions of dollars into the company.

Most of its pipeline drugs are in various stages of clinical trials. A microbiologist turned entrepreneur who is following Moderna told Moneycontrol that theoretically developing and producing mRNA vaccine sounds simple, but it is extremely complex in practice. The expert says that mRNA should be designed in a way not to cause unintended immune reactions. The other problem is delivery of the mRNA. Experts say mRNA strands break down easily, so they are coated with lipid nano-particles (fatty proteins) for delivery.

When will India get the vaccine?

Moderna reported it is possible that under emergency use, a vaccine could be available to some people, possibly including healthcare professionals, in the fall of 2020 (September-December). Analysts say the supply of this vaccine will be tightly controlled. It's obvious that the vaccine will be available in the US first, and possibly in countries that are part of the clinical trials and other friendly nations of the US. India, a member of CEPI that funded the vaccine in its initial phase, may get some priority. The price of the vaccine is not yet decided. But experts say it isn't going to be cheap. Moderna has invested hundreds of millions of dollars on research. It would expect some plough back.

Do Indian institutions have the capability to produce mRNA vaccine?

To be sure, Indian research institutions have been studying mRNA for sometime.One of them is Centre for Cellular and Molecular Biology (CCMB), the CSIR lab. But they haven't yet developed the application of science for treating diseases. At least in the public domain, none of Indian companies has shown the capability to produce therapy using mRNA technology. It is highly unlikely that Moderna or any other biotech would be willing to share the technology.