The FDA’s vaccine advisory committee on Thursday voted 19-0 in support of expanding Moderna’s Covid-19 vaccine EUA for booster doses for certain high-risk individuals. FDA is expected to authorize the Moderna booster shortly.
Similarly to the Pfizer booster shot, Moderna’s will likely be authorized for those older than 65, adults at high risk of severe Covid-19, and adults whose frequent institutional or occupational exposure to SARS-CoV-2 puts them at high risk of serious complications of Covid-19. But unlike the Pfizer adcomm, where FDA had to scramble to get the committee to vote in favor of a booster, this committee was unanimous with the Moderna shot.
Israeli scientists once again presented the latest in their experience with boosters, which showed reduced Covid-19 cases. Several panelists praised how compelling the Israeli data presented were.
Paul Offit, a VRBPAC panelist and professor of pediatrics at Children’s Hospital of Philadelphia, called the data clear for 70- to 79-year-olds, but said he was less impressed with the data for those who are younger.
Others also questioned the data behind the booster, particularly as for Moderna is applying to administer a half-dose of what was provided in the primary, two-shot series.
“The data we have is only limited to about 149 patients on Moderna. So I have some hesitation,” VRBPAC member Jeannette Lee, a professor of biostatistics at the University of Arkansas for Medical Sciences, said.
Panelist Eric Rubin, editor in chief of the New England Journal of Medicine and an expert on infectious diseases at Harvard’s public health school, noted “the data are not perfect,” but these are “extraordinary times.” He also reiterated the idea that the overall effect of a booster is much less than primary vaccines, both here and abroad.
“We need to vaccinate the unvaccinated,” Rubin said.
Other members of the committee explained how the Moderna booster needs to win EUA as it wouldn’t make sense as a practical matter to have a Pfizer booster and not one for Moderna.
FDA’s top vaccine leader Peter Marks offered a similar sentiment in noting that the CDC’s committee, which is likely next up to review the Moderna booster, may decide to further manipulate the recommendations from VRBPAC, “but to the extent that we can come to place that’ll be acceptable for ACIP, that’ll be appreciated.”
VRBPAC panelist Steven Pergam, an expert on infectious diseases at the Fred Hutchinson Cancer Research Center in Seattle, said he is “very supportive” of those with occupational Covid-19 risks receiving the booster, particularly as the US seeks to protect health institutions from outbreaks.
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The biotech sector has come down firmly from the highs of February as negative sentiment takes hold. The sector had a major boost of optimism from the success of the COVID-19 vaccines, making investors keenly aware of the potential of biopharma R&D engines. But from early this year, clinical trial, regulatory and access setbacks have reminded investors of the sector’s inherent risks.
RBC Capital Markets recently surveyed investors to take the temperature of the market, a mix of specialists/generalists and long-only/ long-short investment strategies. Heading into the second half of the year, investors mostly see the sector as undervalued (49%), a large change from the first half of the year when only 20% rated it as undervalued. Around 41% of investors now believe that biotech will underperform the S&P500 in the second half of 2021. Despite that view, 54% plan to maintain their position in the market and 41% still plan to increase their holdings.
Earlier in the week we broadcast our 4th annual European Biopharma Summit with a great lineup of top execs. One of the one-on-one conversations I set up was with Susan Galbraith, the oncology research chief at AstraZeneca. In a wide-ranging discussion, Galbraith reviewed the cancer drug pipeline and key trends influencing development work at the pharma giant. You can watch the video, above, or stick with the script below. — JC
Capping a controversially long period for the FDA to go without a permanent leader, President Joe Biden is likely to select Verily’s Rob Califf, a former FDA commissioner under President Obama, as the next FDA commissioner nominee.
A former Duke cardiologist and member of the prestigious National Academy of Medicine, Califf will be a welcome face for an agency grappling with high-profile retirements in CBER and CDER. He’ll also return to a role that he was comfortable in for a short stint at the end of Obama’s presidency. The Washington Post first reported the news.
With about $10 billion in taxpayer funds invested in Moderna so far, it would seem that the company would be more understanding of pleas from President Joe Biden and the federal government to provide more vaccine doses to low- and middle-income countries.
But the Biden-Moderna feud over supplying the world with doses of mRNA vaccines is now spilling into the public, with Biden’s chief science officer of the government’s Covid-19 response David Kessler explaining the details in an online panel discussion moderated by Yale law professor Amy Kapczynski on Wednesday.
While both Pfizer/BioNTech and Moderna are looking to administer boosters for their Covid-19 vaccines six months after the initial two-dose series, J&J — which has vaccinated about 15 million Americans so far with its one-shot vaccine — is taking a more unique approach with boosters.
According to briefing documents released ahead of Friday’s FDA adcomm on the booster dose, J&J is calling for its boosters to be administered anywhere from two months to six months following the initial shot, depending on the strength of the immune responses.
About five years ago, Amit Etkin had a breakthrough.
The Stanford neurologist, a soft-spoken demi-prodigy who became a professor while still a resident, had been obsessed for a decade with how to better define psychiatric disorders. Drugs for depression or bipolar disorder didn’t work for many patients with the conditions, and he suspected the reason was how traditional diagnoses didn’t actually get at the heart of what was going on in a patient’s brain.
A year and a half after Chinese officials ordered BeiGene to stop selling Bristol Myers Squibb’s Abraxane in the wake of an alarming inspection of a US facility, the manufacturing issues at the root of the import suspension still appear unresolved.
And Bristol Myers wants to axe the Abraxane supply deal altogether.
But BeiGene, which is currently in arbitration proceedings against its Big Pharma partner, won’t let it off the hook so easily.
Nearly a year after being granted an EUA, Regeneron and Roche’s Covid-19 antibody cocktail will now go before the FDA for a chance at full approval.
The big biotech announced Thursday it has submitted a BLA for the drug, shooting for an OK to treat Covid-19 in non-hospitalized patients and as prophylaxis in certain individuals. Regulators granted priority review, setting April 13, 2022 as the PDUFA date, and Regeneron said the agency is preparing an adcomm before then.
As Eli Lilly works to consolidate its internal and Loxo teams into an oncology powerhouse, the drug giant is putting high hopes on CDK 4/6 inhibitor Verzenio to help drive the portfolio into the future. Now, the drug has scored a paradigm-altering win in early breast cancer — but will a controversial companion diagnostic hamstring Lilly’s market plans?
The FDA on Wednesday approved CDK 4/6 inhibitor Verzenio in combination with physician’s-choice endocrine therapy to cut the risk of relapse in patients with high-risk HR-positive, HER2-negative breast cancer, Lilly said in a release.
FIT的保罗是一名VRB PAC泛专家，也是费城Children's Hospi'tal of Philadelphia的体育专家，他称DaTa对70岁至79岁的人来说是明确的，但他说他对年轻人来说DaTa不太感兴趣。
COMmit-tee的成员们讲述了mod-na boost er需要如何赢得EUA，因为作为一个pfiz boost er和mod-na boost er是没有意义的。
美国食品和药物管理局的顶级VAC电影领导人表示，疾病预防控制中心的committee可能会从VRB pac获得更多的信息，“但对于我们能够为ACIP提供信息的ext来说，这将是AP pre-ci。”
vrb pac panelist Steven Pergam是弗莱德·哈钦（Fred Hutchin）Son can recear center，他说他“非常支持”那些新冠肺炎有风险的人，因为美国寻求从休息中恢复健康。
加拿大皇家银行资本市场（RBC Capital Markets）最近对投资者进行了调查，以了解市场的温度，这是专家/通才和只做多/多空投资策略的混合。进入下半年，投资者大多认为该行业被低估(49%)，与上半年只有20%的人认为该行业被低估相比有了很大变化。大约41%的投资者现在认为，生物技术将在2021年下半年表现低于标准普尔500。尽管有这种观点，54%的人计划维持市场头寸，41%的人仍计划增持。
但拜登和莫德纳在向世界提供基因疫苗剂量方面的不和现在正在蔓延到公众，拜登政府新冠肺炎回应的首席科学官大卫·凯斯勒（David Kessler）周三在耶鲁大学法学教授艾米·卡普钦斯基（Amy Kapczynski）主持的在线小组讨论中解释了细节。