Older adults who participated in Moderna’s Phase 1 trial of its Covid-19 vaccine responded just as well as younger adults, according to data the biotech company is presenting to a key Centers for Disease Control and Prevention Advisory panel on Wednesday morning.
That’s important, because not only is Covid-19 more deadly among older people, but vaccines often are less effective in the elderly.
“The whole industry is very focused as to, can we get a vaccine that can protect the elderly,” said Moderna (ticker: MRNA) CEO Stéphane Bancel in a Wednesday morning interview. “It’s always a big question, and so we are super happy.”
The data shows that in the Phase 1 trial, neutralizing antibody levels in ten adults aged 56 to 70, and in another 10 adults aged 71 and up, were as high as the neutralizing antibody levels in the adults aged 18 to 55 whose experiences were reported in a July paper published in the New England Journal of Medicine. Neutralizing antibodies are thought to have a role in blocking Covid-19 infections.
“It’s very consistent,” Bancel says of the neutralizing antibody levels in the older adults. “You don’t have some elderly at very high level and some at very low level. One hundred percent of the elderly have high neutralizing antibodies. It’s very tight between people.”
The company said that no vaccine-related serious adverse events had been reported in the Phase 1 study at the dose level being used in the Phase 3 study, and that the vaccine remained well-tolerated across age groups. T-cell responses, another form of immune response, were similar in the older adults to those in the group of people aged 18 to 55.
The company has not yet published a paper describing the findings. It said that a paper had been submitted for peer review. Moderna is presenting the data on Wednesday at the meeting of the CDC’s Advisory Committee on Immunization Practices, an independent group of outside experts that issues key guidance on which vaccines are administered to Americans, so it would not need to wait to present the data until the committee’s next meeting.
Pfizer (PFE) and BioNTech (BNTX) are also presenting data at Wednesday’s meeting.
The update from Moderna comes days after Pfizer and BioNTech announced updated data on their own Phase 1 trials showing that the version of their Covid-19 vaccine that they chose to take into Phase 3 trials led to less severe reactions than an earlier version of the vaccine.
Moderna’s Phase 3 trial, which aims to include 30,000 patients, began enrolling in late July. A Phase 2 trial is fully enrolled.
As worries around public trust of the Food and Drug Administration have grown louder in recent days following an embarrassing walk-back by the agency’s commissioner, Dr. Stephen Hahn, of an overstatement of the effectiveness of a Covid-19 therapy at a White House briefing Sunday, Bancel said that agency staff had stuck to strict safety standards even amid the race for a Covid-19 vaccine.
“We anticipate that the FDA will have a very high bar on safety first and on efficacy second,” he says.
Bancel said that his company had initially intended to run a Phase 3 study of its Covid-19 vaccine of 10,000 people, but increased to a 30,000-person trial after FDA staff said a larger data set was necessary. “FDA issued a very clear guideline,” he says. “I am confident in the agency’s ability to do the right thing.”
The Financial Times reported over the weekend that the administration is considering issuing an emergency-use authorization to AstraZeneca’s (AZN) Covid-19 vaccine based on the results of the company’s ongoing 10,000-patient trial, rather than waiting on the results of a larger 30,000-patient trial. AstraZeneca said it had not been in discussions with the federal government about an emergency-use authorization.
Meanwhile, on Monday, Hong Kong University scientists issued a paper reporting on the case of a Hong Kong resident who tested positive for Covid-19 twice, leading to a rash of anxious headlines and fears of a neverending Covid-19 pandemic. Experts told Barron’s that the news would have important implications for vaccine developers.
But on Wednesday morning, Bancel said that the fact that the patient had no symptoms the second time he tested positive for Covid-19 was essential, and had been overlooked. His company’s vaccine, he noted, is designed to prevent disease, not infection.
“If you get reinfected… but the vaccine does its job and you don’t get disease, that’s winning,” he says. “If we prevent disease, we will have a vaccine that’s super helpful to the world. And that’s for me the piece that is important.”
Shares of Moderna are up 243% this year. The company has a market capitalization of $26.3 billion, despite having no approved products. Of the 15 analysts who cover Moderna tracked by FactSet, 12 rate it a Buy and three rate it a Hold.
Moderna stock has gained 4.6% at 2:44 p.m. Wednesday, while the Dow Jones Industrial Average has advanced 0.2%, and the iShares Nasdaq Biotechnology ETF (IBB) has dipped 0.5%.
Moderna has scheduled an investor call to discuss the new data at 4:30 p.m. Eastern on Wednesday.
Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com
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August 27, 2020 at 01:49AM
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Moderna’s Covid-19 Vaccine Shows Promise in Older Adults. Its Stock Is Climbing. - Barron's
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