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“12.5% of vaccinated children developed severe or very severe RSV disease, and the data are confidential.接种疫苗的儿童中有 12.5% 患上严重或非常严重的 RSV 疾病，数据保密。”

Moderna’s mRNA vaccine against RSV takes a tumble
The latest trial data demonstrates the dangerous speed of innovation.
MARYANNE DEMASI, PHD
DEC 11

Moderna 的 RSV mRNA 疫苗遭遇失败
最新的试验数据证明了创新的危险速度。
玛丽安·德马西博士
12 月 11 日

https://open.substack.com/pub/maryannedemasi/p/modernas-mrna-vaccine-against-rsv

In September 2024, Moderna announced that the clinical trial of its mRNA vaccine for respiratory syncytial virus (RSV) in children aged 5–24 months was abruptly halted.

The clinical trial, conducted in the UK and other countries, ended after alarming data suggested that the vaccine might not just fail to prevent severe RSV disease, but could potentially worsen it.

Until now, the data were kept secret.

This week, the Food and Drug Administration (FDA) disclosed that vaccinated children in the trial experienced higher rates of severe RSV compared to those in the placebo group.

The data was striking: 12.5% of vaccinated children developed severe or very severe RSV disease, compared to just 5% in the placebo group.

Moreover, among those who developed symptomatic RSV, 26.3% of vaccinated participants progressed to severe illness, sharply contrasting with the 8.3% in the placebo group.

The FDA, which granted the vaccine Fast Track designation in 2021, said the data have “uncertain implications for the ongoing and future pediatric development of other non-live attenuated RSV vaccines.”

Uncertain Implications

The implications of this data are grave, drawing uncomfortable comparisons to the failed RSV vaccine trials of the 1960s.

Those earlier trials were halted after two infants tragically died of RSV disease following administration of a formalin-inactivated RSV vaccine.

This disaster led to the discovery of Vaccine-Associated Enhanced Respiratory Disease (VAERD), a condition where vaccination paradoxically exacerbates the severity of a viral infection, instead of preventing it.

Compounding the concern, similar mRNA RSV vaccines are being trialled in pregnant women, aiming to transfer protective antibodies to their babies.

This has raised alarms among doctors who’ve been following the development of RSV vaccines closely.

Peter Selley, a retired GP said, "The worry is that this, and other RSV vaccines given to pregnant women, might produce the same antibodies in the babies that cause this enhanced disease."

Selley emphasised the need for rigorous oversight in light of past failures.

Speed of innovation

This latest trial data also reignites concerns over the FDA’s expedited pathways.

Fast Track designation, intended to accelerate the approval of treatments addressing urgent medical needs, has a lower burden of proof for safety and has many concerned that it compromises safety in favour of speed.

In the wake of this week’s news, questions are now being raised about whether early warning signs of safety risks were overlooked in the rush to bring the vaccine to market.

Governments have invested heavily in the success of Moderna’s mRNA vaccines.

In 2021, the Australian Federal government signed a $2 billion agreement, committing to the purchase of Moderna’s locally produced vaccines for at least a decade.

These vaccines, including RSV and influenza, are exempt from evaluation by the Pharmaceutical Benefits Advisory Committee, which typically ensures vaccines are safe and effective before being listed on the National Immunisation Program.

The exemption from evaluation has raised red flags, particularly as public trust in vaccine programs and mRNA technology wavers. Peter Collignon, an infectious diseases expert at the Australian National University, called the bypass “problematic.”

But, the Australian government has defended the deal as a strategic investment in "sovereign capability," aimed at preparing for future pandemics. The facility, based at Monash University, Victoria, opened last week.

What now?

The FDA has responded to the latest data by convening a meeting of its Advisory Committee (VRBPAC), scheduled for December 12, 2024, to examine the implications of RSV vaccines in vulnerable groups, including infants and pregnant women.

For parents, the idea that a vaccine could worsen the disease it is meant to prevent, is profoundly unsettling. For scientists, it calls into question the long-term reliability of mRNA as a platform for combating diverse diseases.

The stakes are high—not only for the future of RSV vaccines but for the reputation of mRNA technology as a whole.

The FDA meeting can be watched here: 2024年9月，Moderna宣布突然停止其呼吸道合胞病毒（RSV）mRNA疫苗在5-24个月儿童中的临床试验。

这项在英国和其他国家进行的临床试验结束后，令人震惊的数据表明该疫苗可能不仅无法预防严重的 RSV 疾病，而且可能会使病情恶化。

到目前为止，这些数据一直处于保密状态。

本周，美国食品和药物管理局 (FDA) 披露，与安慰剂组相比，试验中接种疫苗的儿童患严重 RSV 的几率更高。

数据令人震惊：接种疫苗的儿童中有 12.5% 患上严重或非常严重的 RSV 疾病，而安慰剂组中只有 5%。

此外，在出现有症状 RSV 的患者中，26.3% 的接种疫苗参与者病情发展为严重疾病，与安慰剂组的 8.3% 形成鲜明对比。

FDA 于 2021 年授予该疫苗快速通道资格，并表示这些数据“对其他非活减毒 RSV 疫苗正在进行和未来的儿科开发具有不确定的影响。”

不确定的影响

这些数据的影响是严重的，与 20 世纪 60 年代失败的 RSV 疫苗试验相比，令人不安。

由于两名婴儿在注射福尔马林灭活 RSV 疫苗后不幸死于 RSV 疾病，这些早期试验被叫停。

这场灾难导致了疫苗相关增强呼吸系统疾病 (VAERD) 的发现，在这种情况下，疫苗接种反而会加剧病毒感染的严重程度，而不是预防病毒RSV 疫苗正在孕妇身上进行试验，旨在将保护性抗体转移给她们的婴儿。

这引起了密切关注 RSV 疫苗开发的医生的警惕。

退休全科医生彼得·塞利 (Peter Selley) 表示：“令人担心的是，这种疫苗以及其他给孕妇注射的 RSV 疫苗可能会在婴儿体内产生相同的抗体，导致这种疾病加重。”

塞利强调，鉴于过去的失败，需要进行严格的监督。

创新速度

这一最新的试验数据也重新引发了人们对 FDA 加速路径的担忧。

快速通道指定旨在加速批准解决紧急医疗需求的治疗方法，其安全性举证责任较低，许多人担心它会为了速度而牺牲安全性。

本周的消息传出后，人们开始质疑，在急于将疫苗推向市场的过程中，是否忽视了安全风险的早期预警信号。

各国政府为 Moderna mRNA 疫苗的成功投入了大量资金。

2021年，澳大利亚联邦政府签署了一项价值20亿美元的协议，承诺在至少十年内购买Moderna本地生产的疫苗。

这些疫苗，包括 RSV 和流感疫苗，无需接受药品福利咨询委员会的评估，该委员会通常会确保疫苗在列入国家免疫计划之前安全有效。

免于评估引发了危险信号，特别是在公众对疫苗计划和 mRNA 技术的信任动摇的情况下。 澳大利亚国立大学传染病专家彼得·科利尼翁（Peter Collignon）称这条绕道“有问题”。

但是，澳大利亚政府辩称该协议是对“主权能力”的战略投资，旨在为未来的流行病做好准备。 该设施位于维多利亚州莫纳什大学，于上周开业。

现在怎么办？

FDA 对最新数据做出了回应，召开了定于 2024 年 12 月 12 日举行的咨询委员会 (VRBPAC) 会议，以研究 RSV 疫苗对婴儿和孕妇等弱势群体的影响。

对于父母来说，疫苗可能会使本来要预防的疾病恶化，这一想法令人深感不安。 对于科学家来说，这对 mRNA 作为对抗多种疾病的平台的长期可靠性提出了质疑。

这不仅关系到 RSV 疫苗的未来，而且关系到整个 mRNA 技术的声誉，风险很高。

FDA 会议可以在这里观看：