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COVID-19 vaccine: Penn Medicine researcher Dr. Drew Weissman laid groundwork for Pfizer, Moderna vaccines

PHILADELPHIA (WPVI) — A local researcher from Penn Medicine says there’s reason to believe at least one other potential coronavirus vaccine could be as effective as Pfizer’s vaccine is said to be.

“That’s the highest number I have seen for a respiratory vaccine in humans,” said Dr. Drew Weissman from the University of Pennsylvania.

He is pleasantly surprised with Pfizer’s reported 90% efficacy with its experimental coronavirus vaccine. After all, he helped develop the technology for the vaccine.

It’s called messenger RNA or mRNA.

“What’s different about mRNA is it’s a genetic vaccine,” he said.

Other vaccines, such as the flu shot, use live or inactivated virus to create an immune response, but mRNA tricks the body into mounting it’s own defense.

The vaccine made by Moderna is similar and also uses mRNA. Because of that, Dr. Weissman expects similar efficacy.

What’s still unknown is how long immunity from the vaccine would last.

“What we do know is in our animal studies, the antibody responses last a long time. We’ve gone years and antibody response hasn’t dropped in monkeys, so I have high hopes durability will be very good,” he said.

He also hopes enough people choose to get vaccinated to make a difference.

“If they do, the pandemic will be over in a year or so, if they don’t know what’s going to happen,” he said.

Dr. Weissman says when the choice is getting a safe vaccine or getting sick with COVID-19 or passing it on, the decision should be clear.

Dr. Weissman was also a fellow at Dr. Anthony Fauci’s lab years ago.

Copyright © 2020 WPVI-TV. All Rights Reserved.

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Moderna hails diversity of Covid trial participants

Biotech firm Moderna said Thursday that it had successfully recruited ethnic minorities, older people and those with underlying health issues for its Covid-19 vaccines trial, after it pushed to enrol groups most vulnerable to the virus.

Moderna said it had now signed up all 30,000 participants for the phase-3 trial, and more than 25,000 of them had already received a second dose of the vaccine, four weeks after the first.

The firm said it was working “to develop a vaccine for everyone, including communities that have historically been under-represented in clinical research and are disproportionately impacted by Covid-19.”

More than 7,000 people taking part in the trial are over 65, and more than 5,000 under 65 have high-risk diseases such as diabetes, severe obesity and cardiac disease.

The firm said more than 11,000 are “from communities of color, representing 37 percent of the study population and similar to the diversity of the US at large” — 6,000 are Hispanic or Latino, and more than 3,000 are African-American.

Massachusetts-based Moderna is one of the few companies to have launched a large-scale clinical trial less than 10 months after the genetic sequencing of the novel coronavirus was established.

Some Chinese, Russian and other Western projects are also in advanced tests, including US firm Pfizer.

Moderna hopes to have sufficient results by the end of November and to then file an emergency authorization request with the US Food and Drug Administration (FDA).

The company has already said it was aiming to file for authorization soon after November 25, with Pfizer at the third week of November.

The US government says it will distribute the first doses immediately after authorization free of charge.

Health Secretary Alex Azar said Wednesday there would be enough doses to vaccinate the “most vulnerable” Americans before the end of the year, then the elderly and health workers in January, and all Americans by early April.

In the trials, half of the volunteers receive a placebo, and the other half get the vaccine.

Initial FDA guidance stipulated that if the number of participants in the vaccinated group naturally contracting the virus and falling ill with Covid-19 was at least 50 percent lower than in the placebo group, the vaccine would be declared effective.

But on Thursday, a National Institutes of Health official said during a meeting of the FDA’s advisory committee on vaccines that they would require a 60 percent efficacy for emergency use.

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Moderna Says COVID-19 Vaccine Could Be Ready As Soon As December With FDA Approval

KEY POINTS

  • Moderna CEO Stéphane Bancel says its COVID-19 vaccine could begin distribution as soon as December
  • Phase three trial delays could push distribution into early 2021.
  • Moderna expects to meet U.S. demand for the drug. It will also manufacture it in Switzerland for international distribution

Moderna says its COVID-19 vaccine could be ready for U.S. distribution as early as December.

Speaking at a Wall Street Journal tech conference, CEO Stéphane Bancel said Moderna expects interim results from phase three clinical trials by November, a timetable that could place an emergency approval from the FDA in December.

There are still some possible wrinkles, however: Moderna needs a minimum number of their 30,000 volunteers to contract COVID-19 before it can prove those without the vaccine were more likely to do so. Low infection rates could delay results.

If the results from that first population aren’t conclusive, Moderna would need to wait for a larger number of sick volunteers before seeking FDA approval. That would likely push a vaccine timetable into early 2021.

Hopes for a rapid vaccine faced a setback by the suspension of trials for two candidates Hopes for a rapid vaccine faced a setback by the suspension of trials for two candidates Photo: AFP / Ludovic MARIN

Last week vaccine competitor Pfizer said it would be seeking FDA approval in late November, as well, which would put its distribution date in December. Two other potential vaccines from Johnson & Johnson and AstraZeneca have their trials on hold pending investigations into unexplained illnesses among volunteers.

New FDA regulations require that vaccine developers wait two months from the last dose of their drug to prove long-term safety and efficacy. President Donald Trump fought their implementation, hoping to get a vaccine out before the November presidential election.

Both Pfizer and Moderna are set to clear this bar, with Moderna’s trials starting in July. It typically takes several weeks for the FDA to arrive at a decision once the drug is submitted, although if there was ever a drug that would be given extra resources it would be these.

Bancel said that Moderna projects it can produce 20 million doses in 2020, and 500 million in 2021. Moderna and its manufacturing partner, Lonza Ltd. say they will be able to meet U.S. demand. They will also be manufacturing the drug in Switzerland to distribute internationally.

Despite their expectations, Bancel said that manufacturing vaccines is a complex process with many moving parts that need to come together simultaneously.

“Unlike sometimes when you make a recipe at home, if you miss one ingredient, you might decide to still go ahead and make your meal,” he said, “In our case we cannot do that. We need all the ingredients to be there on time to be able to make a lot of vaccine.”

“If one ingredient is missing, we cannot make a vaccine.”

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