Covid-19 vaccines

Ahead of a planned booster vaccination campaign this fall, the U.S. government has locked up supply of Moderna Covid-19 vaccines designed to protect against both the original strain of the virus as well as the omicron subvariants that are now circulating widely.

According to terms announced Friday, Moderna will supply the government with 66 million doses of its booster vaccine candidate. The contract includes the option to purchase up to 234 million booster doses. Moderna could be paid up to $1.74 billion, depending on how many doses are ordered.

The Moderna vaccine, named Spikevax, received FDA approval in January for those 18 and older. That vaccine was designed to address the original strain of the novel coronavirus. The company has also been developing two different booster candidates, each a bivalent vaccine that protects against two different strains. Both of these new vaccines will protect against the original strain. One of them, mRNA-1273.222, will also contain the BA.4/5 omicron strain that is dominant in the U.S., consistent with booster guidelines that the FDA set last month. The second booster candidate, mRNA-1273.214, addresses the BA.1 subvariant, which may be more applicable to other regions in the world.

The contracted supply of Moderna boosters is in addition to the agreement the government struck for 105 million bivalent booster doses of the Pfizer/BioNTech Covid-19 vaccine, plus the option to purchase up to 195 million additional doses. Both boosters will need FDA authorization and a recommendation from the Centers for Disease Control and Prevention. If these new shots pass muster with both agencies, they could be ready to go into arms in early fall, the Department of Health and Human Services said. Citing unnamed sources, The New York Times reported that the Biden administration plans to offer the updated Covid-19 shots in September.

As of now, boosters have FDA authorization for those 50 and older as well as those 12 and older who have conditions that impair their immune systems. The Times reported that due to the rising number of Covid-19 cases, some federal health officials advocated for broadening booster eligibility of the current vaccine ahead of the rollout of the retooled versions. But after the companies assured government officials that they could deliver their bivalent boosters by mid-September, the FDA and CDC decided it would be better to focus on the fall vaccination campaign with the new versions of the shots, the Times reported.

According to the CDC, 603.7 million vaccine doses have been administered in the U.S. The agency calculates that 78.8% of the U.S. population has received at least one dose and 67.2% of the population is fully vaccinated (defined as those who have received the second dose of a two-shot vaccine or one dose of the single-shot Johnson & Johnson vaccine). Of those who are fully vaccinated, the CDC reports that 107.9 million people have received a booster shot. More than half of the total booster-eligible population has yet to receive a booster shot, the CDC’s latest data show.

Photo: Michael Sohn – Pool/Getty Images

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A coalition, comprising of health technology companies, providers and nonprofits, announced Thursday that they will establish an initiative to provide people with digital access to their Covid-19 vaccination records.

Two vaccines have so far been approved for administration in the U.S. — one developed by Pfizer and BioNTech, and the other by Moderna. The collaborative effort comes as doses of the vaccines are slowly making their way across the country, and people are figuring out what the next phase of the pandemic will look like.

That new phase will likely present unique challenges, including tracking who gets which vaccine, whether they get a one-or two-dose vaccine, where they receive their vaccine and so on, said Dr. John Halamka, president of Mayo Clinic Platform, in a phone interview. Currently, both Modera and Pfizer/BioNTech’s vaccine require two doses three to four weeks apart.

As the country thinks about opening back up and resuming to pre-pandemic levels of activity, “we [will] need a vaccine credential we can trust,” he said.

Mayo Clinic is just one of the high-profile organizations that have joined the coalition to create the Vaccination Credential Initiative. Others include Microsoft, Mitre, The Commons Project Foundation as well as EHR giants Epic and Cerner.

“We saw this as a critical opportunity to help our healthcare organizations and the world start the recovery process,” said David Bradshaw, senior vice president, consumer and employer solutions at Cerner, in an email. “We know vaccines will play a critical role in that and we wanted to be able to proactively inform and design to the specifications.”

The Vaccination Credential Initiative is developing a QR code that will enable individuals to easily provide their vaccination credentials when needed, Halamka explained.

The coalition has agreed on the standard for how the vaccine credential gets displayed in the QR code, he said. The standard was created by Josh Mandel, chief architect at Microsoft Healthcare, and is called the SMART Health Cards specification. It was developed with a short-term goal of allowing an individual to receive the Covid-19 vaccine or lab results and present these results to another party in a verifiable manner. The specification is based on the W3C Verifiable Credential — a credential that has authorship that can be cryptographically verified — and HL7 Fast Healthcare Interoperability Resources standards.

Now, the coalition needs to work on the “underlying plumbing behind it,” Halamka said. This includes figuring out how the patient gets access to the code after receiving the vaccine from whichever site they select — their doctor’s office, a Walgreens, a CVS, or any other vaccination site. Patients will have full control over their QR code and will be able to access it through any smartphone. They will have also the option of printing it out and keeping a physical copy. 

The coalition’s efforts come on the heels of a much-maligned vaccine rollout. More than 30 million doses of the Covid-19 vaccines have been distributed, but only a little over 11 million have been administered, according to data from the Centers for Disease Prevention and Control.

In an effort to speed up the process, the Trump administration announced Tuesday that it plans to release all reserves of vaccine doses that were initially held back to administer second doses, The New York Times reported. The administration also told states to begin vaccinating every individual 65 and older and people with underlying medical conditions.

Looking ahead, the incoming administration has made it clear that vaccine distribution will be an early priority, with President-elect Joe Biden saying in a speech Thursday that his relief plan will include “hundreds of billions” of dollars for a national vaccination program and public health initiatives like testing and contact tracing, NPR reported. Biden has also committed to having 100 million people vaccinated in his first 100 days.

While that goal seems ambitious, were it to be achieved, getting back to normal will require a verifiable record of people being vaccinated.

Halamka believes that coalitions like this one can have a huge impact on easing that transition.

“When I see nontraditional coalitions coming together — and that means government, academia, industry — all work[ing] together for the benefit of society, we can achieve great change,” he said.

Photo: Teka77, Getty Images

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The next generation of antibody testing for Covid-19 is beginning to take shape.

Initial tests determined whether someone had or did not have antibodies to the virus’s signature spike protein. A new crop promises to quantify the antibodies, an advance that could be crucial as researchers seek to understand longer-term immunity from the virus, whether acquired through vaccines or natural infection. But that is not the only question out there.

“There’s still a lot to be learned,” said Michael Haydock, a senior director at Informa Pharma Intelligence in London.

For example, he said, researchers don’t know if there is a threshold number of antibodies a person needs to maintain immunity, Haydock said. Quantitative tests could help pinpoint a threshold and track whether antibodies fall below it, potentially necessitating a booster vaccine.

“Measuring that is going to be very important,” Haydock said in a phone interview. Tests also may be able to quantify differences in immune response based on age, race and other factors.

In addition, quantitative tests can be used to assess people who have recovered from Covid-19 and want to donate plasma for use in convalescent plasma therapy, a treatment for the virus. Researchers also may be interested in understanding the response to Covid-19 vaccines among those who are already on therapies that modify their immune systems.

“That’s the nature of this pandemic, that you’re trying to move forward when you have more questions than you have answers. Antibody testing can help answer those questions,” said Sara Barrington, chief commercial officer for Kantaro Biosciences.

The New York-based company offers a quantitative antibody test for Covid-19 using technology developed at Mount Sinai Health System early in the pandemic. Kantaro is a joint venture between Mount Sinai and RenalytixAI, a diagnostics company based in the United Kingdom.

Complicating the issue is the lack of an agreed-upon standard for measuring antibodies. However, clarity is on the horizon.

The World Health Organization is expected to set standards soon, Barrington said in a phone interview.

“With an international standard, you’d be able to compare the results across different tests,” said Erik Lium, Kantaro’s chairman and the chief commercial innovation officer at Mount Sinai.

In November, the Food and Drug Administration approved Kantaro’s test for emergency use. But the approval comes with a qualification: the test, called COVID-SeroKlir, is considered semi-quantitative.

The FDA appears to be waiting for the international standard to be set before declaring tests fully quantitative, Barrington said. However, European regulators are not waiting. They cleared COVID-SeroKlir for use as a fully quantitative test.

Other tests also have won clearance. One was developed by drug maker Roche, based in Basel, Switzerland. Its test – the Elecsys Anti-SARS-CoV-2 S – is being used in a partnership with Covid-19 vaccine maker Moderna to trace antibody responses in vaccine-trial participants. Like Kantaro’s, the Roche test was approved for emergency use as a semi-quantitative test.

Some are looking beyond Covid-19 to other infections.

A group of researchers from Linnaeus University and bioanalysis company Attana, both in Sweden, is developing a quantitative test for Covid-19, as well as the bacteria that causes tetanus.

“Our vision is a general diagnostics platform that is relevant not just at present, during the ongoing pandemic, but one that will also serve a greater, broader purpose in the future” Teodor Aastrup, Attana’s CEO, said in a statement.

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