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 presented Wednesday morning to a key Centers for Disease Control and Prevention Advisory panel.
This is important because Covid-19 is not only more lethal to older people, but vaccines are often less effective in older people.
“The whole sector is very focused, we can get a vaccine that can protect the elderly,” Moderna (ticker: MRNA) CEO Stéphane Bancel said in an interview on Wednesday morning. “It’s always a big question, and so we’m super happy.”
The data show that in the Phase 1 trial, anti-anti-anti-levels in ten adults aged 56 to 70, and in another 10 adults aged 71 and over, were as high as the neutralizing anti-anti levels. levels in 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 play a role in blocking Covid-19 infections.
“It’s very consistent,” Bancel says of the neutralizing antibody level in older adults. ‘You do not have some parents at very high levels and others at very low levels. One hundred percent of the elderly have high neutralizing antibodies. It is very tight between people. ”
The company said that no vaccine-related serious adverse events were reported in the Phase 1 study at the dose level 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 older adults to those in the group of people aged 18 to 55 years.
The company has not yet published a paper describing the findings. It said a paper was submitted for peer review. Moderna will present the data on Wednesday at the meeting of the CDC’s Advisory Committee on Immunization Practices, an independent group of outside experts who will provide important guidance on what faxes are being delivered to Americans, so it is not necessary to wait to present the data until the next meeting of the committee.
Pfizer (PFE) and BioNTech (BNTX) will also present data at Wednesday’s meeting.
Moderna’s update comes days after Pfizer and BioNTech announced updated data on their own Phase 1 trials showing that the version of their Covid-19 vaccine they chose in Phase 3 trials leads to less serious reactions than an earlier version of the vaccine,
The Phase 3 trial of Moderna, which aims to admit 30,000 patients, began enrolling in late July. A Phase 2 trial is fully enrolled.
As concerns about the public trust of the Food and Drug Administration have grown louder in recent days following a shameful walk-back by the bureau’s commissioner, Dr. Stephen Hahn, of an overstatement of the effectiveness of a Covid-19 therapy at a White House briefing Sunday, told Bancel that bureau staff adhere to strict safety standards even amid the race for a Covid-19 vaccine.
“We expect the FDA to have a very high bar first on safety and on effectiveness second,” he says.
Bancel said his company initially aimed to conduct a Phase 3 study of its 10,000-person Covid-19 vaccine, but increased to a 30,000-person trial after FDA officials said it needed a larger dataset used to be. “The FDA issued a very clear guideline,” he says. “I’m 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 emergency authorization to AstraZeneca‘s
(AZN) Covid-19 vaccine based on the results of the company’s ongoing 10,000-patient trial, instead of waiting for the results of a larger 30,000-patient trial. AstraZeneca said it had not been in talks with the federal government about an authorization for emergency use.
Meanwhile, Hong Kong University scientists on Monday published a paper report on the case of a Hong Kong resident who tested positive for Covid-19 twice, leading to a flurry of feared headlines and fears of a never-ending Covid-19 -pandemy. Experts told Barron’s that the news would have significant implications for vaccine developers.
But on Wednesday morning, Bancel said the fact that the patient the second time he had no positive symptoms for Covid-19 was essential, and was overlooked. His company’s vaccine, he notes, is designed to prevent disease, not infection.
“If you get infected again … but the vaccine does its job and you do not get any disease, that is winning,” he says. “If we prevent disease, we will have a vaccine that is super useful for the world. And that, to me, is the piece that matters. ”
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 review Moderna, followed by FactSet, 12 rate it a Buy and three rate it a Hold.
Modern shares rose 4.6% at 14:44 on Wednesday, while the Industrial Dow Jones Industrial Average rose 0.2%, and the iShares Nasdaq Biotechnology ETF (IBB) 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 by [email protected]