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Exclusive look inside Moderna: Tracking variants and the call for COVID-19 boosters – National


Walk inside Moderna and the feeling of urgency is palpable.

It makes sense. The world has been struggling under a pandemic for almost two years, and the biotech firm is fighting to stay ahead of COVID-19, which has killed more than 4.5 million people worldwide.

Moderna’s manufacturing site is located 40 minutes outside of Boston, a former Polaroid plant, where vaccine production lines operate around the clock, executives function on minimal sleep, and employees are fuelled by a cocktail of adrenaline and purpose.

For two days in September, Global News became the only Canadian news outlet ever to be invited inside Moderna’s operations — for a first-hand look at its manufacturing hub and its headquarters.

WATCH: Inside Moderna and its fight to stay ahead of the virus


Click to play video: 'Inside Moderna and its fight to stay ahead of the virus'







Inside Moderna and its fight to stay ahead of the virus


Inside Moderna and its fight to stay ahead of the virus

Seventy-five per cent of Moderna’s U.S. supply comes from its Norwood technology centre, a cluster of three buildings which are referred to as a “campus” with “neighbourhoods.”

The site is growing by the day in an attempt to keep up with global demand.

“To give you a feel for how fast we scaled, we’re right now, in manufacturing, around a thousand employees. We have doubled in about five months,” Scott Nickerson, the company’s senior vice-president of U.S. manufacturing told Global News. ”We’re trying to hire about 500 more as we speak.”

The centrepiece of the Norwood plant is the production line — showcased through walls of glass, highlighting the intricacy of the manufacturing process.

Teams work to produce everything from personalized cancer vaccines to its COVID-19 vaccine, mRNA-1273.

“In the case of the coronavirus, we got the sequence from China in early January and within a number of days, down to about a week, we were able to come back with a number of different development candidates that we could try out in our labs before we went into (production),” said Nickerson.

The first step in making a vaccine begins at a computer, when a DNA sequence is entered into Moderna’s proprietary software, called the Drug Design Studio. The DNA is then transcribed into messenger RNA (mRNA), which gives the body instructions on how to fight a pathogen.

A giant steel box, which looks like an oversized fridge, completes one of the most crucial steps: covering the mRNA in a fatty envelope, called a lipid nano-particle, which allows it to enter human cells. The finished product is then filtered, frozen and shipped out of state to be bottled.

Throughout the process, preventing contamination is paramount.

Rooms are routinely monitored for microbes and different sections of the manufacturing floor are meticulously colour-coded and taped off. Sensors, typically used by the NFL to track athletes, are mounted on the ceiling to follow employees through a receiver on their ID badge. This ensures operators working in one area don’t cross over into another.

“We have an alarm that will go off if the operator goes outside of the space they’re supposed to (work)  in,” Nickerson said. “It’s important.”

As countries around the globe struggle with resurging COVID-19 cases fuelled by the highly infectious Delta variant, Moderna is tacking its sails by tailoring boosters shots to the virus’s mutations.

The company has six different boosters in its pipeline, including ones targeting the Delta variant and the Beta variant, multivalent boosters which combine formulations — even a COVID-19 booster combined with a flu shot.

“We’ve probably tested over 100 different variants and their mutation combinations over the last six months alone,” said Moderna’s president, Stephen Hoge. “The moment there’s the first posting of a new sequence to the international databases, we download that … we start testing against it.”


Click to play video: 'Delayed second COVID-19 vaccine doses giving lasting protection'








Delayed second COVID-19 vaccine doses giving lasting protection


Delayed second COVID-19 vaccine doses giving lasting protection

For now, Moderna believes its original formulation holds up against the dominant variants in circulation. The question is: for how long?

“Our clinical trials, which are the longest exposures to the vaccine and the virus that we have, are starting to suggest to us that it’s time to get concerned and get ready,” Hoge said.

Moderna has been studying the response to its vaccine since the summer of 2020, when it enrolled 30,000 people in Phase 3 of its clinical trials.

Data from that trial indicates antibody levels start to wane about six months after the second shot.

While it is expected antibodies will decrease over time, Hoge says troubling signals came this summer, at the height of the Delta variant outbreak in the U.S., when they started to see a significant spike in breakthrough cases of symptomatic COVID-19, among fully vaccinated clinical trial participants.


Click to play video: 'U.S. FDA, CDC support Pfizer-BioNTech boosters for people high-risk or aged 65+'







U.S. FDA, CDC support Pfizer-BioNTech boosters for people high-risk or aged 65+


U.S. FDA, CDC support Pfizer-BioNTech boosters for people high-risk or aged 65+ – Sep 23, 2021

It’s not clear if the driving force behind those breakthrough cases is the increased transmissibility of the Delta variant or a decrease in the effectiveness of the original two-dose vaccine.

“We don’t know,” said Hoge. “What we can say is the combination of Delta and about nine to 12 months of time since your vaccine is leading to substantially higher breakthrough rates in our clinical trial.”

Moderna is erring on the side of caution, asking regulators in the U.S. to green-light a half-dose (50 micrograms) of its original vaccine for use six months after the second shot. Hoge says its data shows the booster brings antibody levels even higher than after the initial shots across all age groups.

“What we’re doing as a manufacturer is making sure that the options are there,” he said. “It will ultimately fall to groups like NACI and Health Canada to decide whether to deploy (boosters) in populations.”

Moderna has not yet submitted an application for its booster to Health Canada, but it is expected imminently.

In September, Canada’s National Advisory Committee on Immunization (NACI) updated its guidance to give additional doses of COVID-19 vaccines to people who are immunocompromised or living in congregate care settings, like long-term care homes.

Many Canadian scientists studying COVID-19 vaccines push back against the notion of boosters at this point, saying the protection from two doses is still robust — especially against the target objective of preventing severe outcomes, like hospitalization and death.

 

WATCH: President of Moderna defends booster shots, but says it’s up to regulators and public health officials to make the call on who gets them and when  


Click to play video: 'TNR Extra: Moderna’s president defends push for COVID-19 boosters'







TNR Extra: Moderna’s president defends push for COVID-19 boosters


TNR Extra: Moderna’s president defends push for COVID-19 boosters

Hoge’s concern is if breakthrough infections – which have generally been mild or moderate – become severe.

“If that is the tip of the iceberg and those breakthrough infections eventually become severe infections, maybe a few months later and then, God forbid, death — we really will wish that we had boosted people to maintain the high-level protection they’ve been enjoying through the early part of this year,” Hoge said.

Asked about a possible conflict of interest for a pharmaceutical company to be promoting the need for more of its product, Hoge said the company is “already fully deployed” in its manufacturing.

“This isn’t a question about whether or not we are actually going to be able to make more or sell more doses. We literally don’t have them to sell,” he said. “We’re just trying to provide data to key regulators and public health officials that help them decide whether or not a third dose is necessary to protect their people.”

Read more:
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Some in the scientific community say the booster we truly need is for the variant we haven’t seen yet. That’s exactly what Hoge’s teams are watching for: a mutation that combines the increased transmissibility of Delta and what is called an “immune-escape” version of COVID-19, which could hide from the body’s immune system or an existing vaccine.

“Is (COVID-19) going to co-evolve in a new variant? Not Delta, not Beta, not Gamma, but some new variant to be named,” Hoge said. “The approach we’re taking scientifically is we’re bringing forward what’s called a multivalent vaccine, (combining) multiple different variants of concern and trying to protect against the places we think the virus is going to go.”

Moderna already has two multivalent vaccines in the pipeline: one combined with the Delta variant, another combined with Beta. Should it require a completely new booster, Moderna says it could have a candidate in clinical development and in the hands of regulators in as little as three months.

“That one sequence that looks like it combines all the mutations that scare us the most will be the one that we have to run towards as fast as possible.”

© 2021 Global News, a division of Corus Entertainment Inc.



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