thinkpool

The remdesivir recall

Gilead recently announced a voluntary nationwide recall of two lots of Veklury. The US Food and Drug Administration (FDA) shared the announcement on its website, as is customary for such recalls.

The company explained that it issued the COVID-19 drug recall after investigating a customer complaint. Some vials contained glass particulates, which can pose a health risk to patients. Glass particles can sometimes end up contaminating products, which leads to recalls when it’s discovered. Gilead explains:

The administration of an injectable product that contains glass particulates may result in local irritation or swelling in response to the foreign material. If the glass particulate reaches the blood vessels it can travel to various organs and block blood vessels in the heart, lungs or brain which can cause stroke and even lead to death.

However, Gilead also noted that it has not received any reports of adverse events related to the remdesivir recall.

The first COVID-19 breakthrough drug

Remdesivir turned out to be the first significant breakthrough drug of the pandemic, although the COVID-19 therapy is far from perfect. Studies have found the anti-viral to hasten recovery in some patients, especially if administered early after infection. But the drug isn’t a life-saving medicine that can significantly reduce the risk of death.

Also important to note is that remdesivir isn’t a drug you can take at home. Medical professionals administer it intravenously. That’s why the COVID-19 drug recall will not impact patients directly. You won’t have to throw out remdesivir vials or return them to the manufacturer because only hospitals get them. It’s still important to be aware of recalls like this, however.

The recalled COVID-19 drug is distributed in single-dose clear vials in powder form. Hospital pharmacies then reconstitute it on-site for intravenous injection.

Gilead explained that Veklury lots 2141001-1A and 2141002-1A are part of the COVID-19 drug recall. Vials from these two lots were available nationwide in the US.

What you need to do

The COVID-19 drug recall will not impact any patients directly. Gilead notified hospitals of the recall. Furthermore, the company will facilitate the return of any remaining vials from the two lots. Gilead instructed the hospitals that have supply from those lots to stop using them. They should return the product vials to Gilead.

Coronavirus patients will not have to deal with the drug recall themselves. The same goes for anyone else. Again, this COVID-19 drug is only available after admittance to a hospital following a positive COVID-19 diagnosis.

COVID-19 survivors who received remdesivir during their hospitalization can talk to their doctors to ensure they’re not from the recalled lots. Anyone who suspects an adverse reaction can contact Gilead and the FDA’s MedWatch Adverse Event program. The COVID-19 drug recall announcement includes all the contact information — check it out at this link.

Chris Smith started writing about gadgets as a hobby, and before he knew it he was sharing his views on tech stuff with readers around the world. Whenever he's not writing about gadgets he miserably fails to stay away from them, although he desperately tries. But that's not necessarily a bad thing.

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Back in July 2021, many scientists had the ill-founded view that the C-19 pandemic was dying out and entering an endemic state. Based on my understanding of the interplay between the virus and the immune system, I knew that this was not going to be the case and reacted immediately to this misinterpretation (https://www.voiceforscienceandsolidarity.org/scientific-blog/a-last-word-of-caution-to-all-those-pretending-the-covid-19-pandemic-is-toning-down). Once again, many scientists find themselves with the belief that the emergence of the Omicron variant announces the end of the pandemic and the virus’ transition into endemicity. Their prediction is largely based upon the initial observation that Omicron seems to be causing rather mild disease symptoms which they interpret as being indicative of a virus that—although more infectious—is now becoming less virulent and, therefore, increasingly featuring endemic behavior. I am afraid that once again, I don’t agree—a pandemic can only be tamed by herd immunity. Given the high vaccine coverage rates in most industrialized countries, we have generated anything but herd immunity. I also have yet to hear any compelling evidence concerning significant mutations in the genes that determine SARS-CoV-2’s virulence. Perhaps we should think twice before making statements that are not supported by immunological evidence.

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This is what I believe is currently happening.

2021년 7월, 많은 과학자들은 C-19 대유행이 사라지고 풍토병으로 접어들고 있다는 잘못된 견해를 가지고 있었다. 바이러스와 면역체계의 상호작용에 대한 이해를 바탕으로, 저는 이것이 그렇지 않을 것이라는 것을 알았고 이러한 잘못된 해석에 즉시 반응했습니다https://www.voiceforscienceandsolidarity.org/scientific-blog/a-last-word-of-caution-to-all-those-pretending-the-covid-19-pandemic-is-toning-down). 다시 한번, 많은 과학자들은 오미크론 변종의 출현은 대유행의 종말과 바이러스가 풍토성으로의 전환을 알린다는 믿음을 가지고 있다. 그들의 예측은 오미크론이 가벼운 질병 증상을 일으키는 것으로 보이는 초기 관찰에 주로 기초하고 있는데, 그들은 오미크론이 전염성이 더 강해지기는 하지만 이제는 덜 치명적이고 따라서 점점 더 풍토적인 행동을 특징으로 하는 바이러스로 해석한다. 유감스럽게도 다시 한 번 동의하지는 않는다. 전염병은 집단 면역에 의해서만 길들여질 수 있다. 대부분의 선진국들의 높은 백신 보급률을 고려할 때, 우리는 집단 면역력을 제외한 모든 것을 만들어냈다. 또한 SARS-CoV-2의 독성을 결정하는 유전자의 중요한 돌연변이에 관한 어떤 설득력 있는 증거도 아직 듣지 못했습니다. 면역학적 증거가 뒷받침되지 않는 발언을 하기 전에 다시 한번 생각해봐야 할 것 같다.

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이것이 제가 현재 일어나고 있다고 믿는 일입니다.

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​As Omicron appears largely resistant to neutralizing antibodies (Abs), it no longer strongly binds to vaccinal Abs (still directed at the spike protein [S] of the Wuhan strain). More specifically, Omicron allows for the restoring of full functional capacity of relevant innate Abs. The latter are known to be very efficient in preventing or abrogating productive infection and, therefore, preventing (severe) disease in individuals endowed with an intact innate immune system (i.e., people in good health and without underlying diseases or immune suppression, including vaccine-mediated immune suppression). As vaccinal neutralizing Abs are highly specific, they are less likely to bind to the receptor-binding domain (RBD) of Omicron, which has undergone a multitude of mutations within this very domain. It is, therefore, reasonable to expect that the vaccine-mediated Abs will fail to outcompete relevant innate Abs in vaccinees and hence, increase the incidence of asymptomatic infections in this population. It is intriguing that the Israeli Ministry of Health interprets asymptomatic infection in vaccinees as proof of “full protection” despite the fact that Omicron is highly suspicious of bypassing neutralizing antibodies (1, 2). Asymptomatic disease is known to lead to a short duration of anti-S Ab titers (3, 4). However, due to the high level of infectivity of Omicron, re-exposure to the virus is highly likely to occur with a timeframe that is short enough to coincide with elevated anti-S Ab levels. Consequently, dominant circulation of Omicron would ultimately make vaccinees more frequently susceptible to disease, whereas fewer and fewer unvaccinated individuals would be susceptible to contracting C-19 disease as a result of innate immune training upon viral exposure. In conclusion, it seems highly unlikely that dominant circulation of Omicron will result in diminished incidence of disease and cause the pandemic to transition into an endemic state. In contrast to the situation in the pre-Omicron era, the incidence of disease is now likely to disproportionately increase in vaccinees. This may, once again, prompt public health authorities to follow the erroneous advice of the vaccine industry and key opinion leaders who will undoubtedly recommend to continue the mass vaccination program using updated vaccines that suit the S version of the Omicron variant. In a previous contribution, I’d already predicted the dire consequences such a decision would entail (https://www.voiceforscienceandsolidarity.org/scientific-blog/mass-vaccination-will-push-sars-cov-2-spike-protein-beyond-omicron)—in brief, it will allow the virus to make a natural selection favoring hosts who preserved a fully functional innate immune defense.

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​오미크론은 항체 중화(Abs)에 크게 저항하는 것으로 나타나기 때문에, 더 이상 백신 Abs에 강하게 결합하지 않는다. 좀 더 구체적으로 말하면, 오미크론은 관련된 선천적 복근의 완전한 기능적 능력을 회복할 수 있다. 후자는 생산적인 감염을 예방하거나 퇴치하는데 매우 효율적인 것으로 알려져 있으며, 따라서 온전한 선천적 면역 체계를 가진 사람(즉, 건강하며 백신 매개 면역 억제를 포함한 근본적인 질병이나 면역 억제가 없는 사람)의 질병을 예방한다. 백신 중화 Abs는 매우 특이적이기 때문에, 바로 이 도메인 내에서 다수의 돌연변이를 겪은 오미크론의 수용체 결합 도메인(RBD)에 결합할 가능성이 낮다. 따라서 백신 매개 Abs가 백신에서 관련 선천적 Abs를 능가하지 못하여 이 집단에서 무증상 감염의 발생을 증가시킬 것이라고 예상하는 것이 타당하다. 이스라엘 보건부가 오미크론의 중화항체 우회 의심(1, 2)이 큰데도 백신 무증상 감염을 '완전 보호'의 증거로 해석한 것은 흥미로운 대목이다. 무증상 질환은 항S Ab 역가(3, 4)의 지속 시간을 짧게 하는 것으로 알려져 있다. 그러나 오미크론의 높은 감염률로 인해 항SAb 수치가 상승할 정도로 짧은 시간 내에 바이러스에 다시 노출될 가능성이 높다. 결과적으로, 오미크론의 지배적인 순환은 궁극적으로 백신을 질병에 더 자주 취약하게 만드는 반면, 백신 접종을 받지 않은 사람들은 바이러스 노출에 따른 선천적 면역 훈련의 결과로 C-19에 감염되기 쉽다. 결론적으로, 오미크론의 지배적인 순환이 질병의 발생을 감소시키고 유행병이 풍토병으로 변질될 가능성은 매우 낮아 보인다. 오마이크론 이전의 상황과 달리, 질병의 발생은 현재 백신에서 불균형적으로 증가할 가능성이 높다. 이것은 다시 한번 공공보건당국들로 하여금 백신 업계와 오미크론 변종의 S 버전에 맞는 업데이트된 백신을 사용하여 대량 예방접종 프로그램을 계속하도록 의심할 여지 없이 권고할 핵심 의견 지도자들의 잘못된 조언을 따르도록 자극할 수도 있다. 이전 기고문에서, 저는 그러한 결정이 수반할 심각한 결과를 이미 예측했습니다https://www.voiceforscienceandsolidarity.org/scientific-blog/mass-vaccination-will-push-sars-cov-2-spike-protein-beyond-omicron)—간단히 말하자면, 바이러스가 완전한 기능을 타고난 i를 보존한 호스트를 선호하는 자연 선택을 할 수 있도록 할 것입니다.mmune 방어

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Geert Vanden Bossche received his DVM from the University of Ghent, Belgium, and his PhD degree in Virology from the University of Hohenheim, Germany. He held adjunct faculty appointments at universities in Belgium and Germany. After his career in Academia, Geert joined several vaccine companies (GSK Biologicals, Novartis Vaccines, Solvay Biologicals) to serve various roles in vaccine R&D as well as in late vaccine development.

Geert then moved on to join the Bill & Melinda Gates Foundation’s Global Health Discovery team in Seattle (USA) as Senior Program Officer; he then worked with the Global Alliance for Vaccines and Immunization (GAVI) in Geneva as Senior Ebola Program Manager. At GAVI he tracked efforts to develop an Ebola vaccine. He also represented GAVI in fora with other partners, including WHO, to review progress on the fight against Ebola and to build plans for global pandemic preparedness.

Back in 2015, Geert scrutinized and questioned the safety of the Ebola vaccine that was used in ring vaccination trials conducted by WHO in Guinea. His critical scientific analysis and report on the data published by WHO in the Lancet in 2015 was sent to all international health and regulatory authorities involved in the Ebola vaccination program. After working for GAVI, Geert joined the German Center for Infection Research in Cologne as Head of the Vaccine Development Office. He is at present primarily serving as a Biotech / Vaccine consultant while also conducting his own research on Natural Killer cell-based vaccines.

게르트 반덴 보쉬는 벨기에 겐트 대학교에서 DVM을, 독일 호엔하임 대학교에서 바이러스학 박사 학위를 받았다. 그는 벨기에와 독일의 대학에서 겸임 교수직을 맡았다. 아카데미에서 경력을 쌓은 후, 그는 여러 백신 회사(GSK Biologicals, Novartis Viagins, Solvay Biologicals)에 입사하여 백신 연구개발뿐만 아니라 후기 백신 개발에서 다양한 역할을 담당했다.

그 후 그는 미국 시애틀에 있는 빌 & 멜린다 게이츠 재단의 글로벌 헬스 디스커버리 팀에 선임 프로그램 책임자로 합류했고, 제네바에 있는 GAVI에서 선임 에볼라 프로그램 매니저로 일했다. GAVI에서 그는 에볼라 백신 개발 노력을 추적했다. 그는 또한 세계보건기구(WHO)를 포함한 다른 파트너들과 함께 GAVI를 대표하여 에볼라 퇴치에 대한 진행상황을 검토하고 전세계적인 전염병 대비를 위한 계획을 수립했다.

2015년 기니에서 세계보건기구(WHO)가 실시한 링 예방접종 실험에 사용된 에볼라 백신의 안전성에 대해 자세히 조사하고 의문을 제기했다. 세계보건기구(WHO)가 2015년 랜싯에서 발표한 데이터에 대한 그의 비판적 과학적 분석과 보고서는 에볼라 백신 접종 프로그램에 관련된 모든 국제 보건 및 규제 당국에 보내졌다. GAVI에서 일한 후, Geert는 백신 개발 사무소의 책임자로서 쾰른에 있는 독일 감염 연구 센터에 들어갔다. 그는 현재 주로 바이오테크/백신 컨설턴트로 활동하고 있으며 천연 킬러 세포 기반 백신에 대한 자체 연구도 수행하고 있다.