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Women reporting worse side effects from COVID-19 vaccines

By Wink News on 12/03/2021 04:03

One group of people is experiencing worse side effects from the COVID-19 vaccines. Men and women react differently to a variety of drugs, but as more vaccine doses get into arms, women have reported more severe reactions to the shots. Migena Gace had hesitations about the coronavirus vaccine back in September. “I’m not going to […]

Novavax’s Covid-19 Vaccine Effective In U.K. Study

By The Wall Street Journal on 12/03/2021 00:17

The vaccine didn’t perform as well in a similar late-stage study in South Africa where an elusive coronavirus strain is circulating, though it still was nearly 49% effective.

COVID-19 lessons for research

By Science Magazine on 12/03/2021 00:00

As we mark the 1-year anniversary of the declaration by the World Health Organization (WHO) of COVID-19 as a global pandemic, the world has suffered a staggering and tragic human toll. During this dark time, the scientific community has been called to rise to the occasion in unprecedented ways. The intensity of the work and the sense of urgency have been unremitting and exhausting. As we sort out the triumphs and frustrations, we can begin to reflect on what we have learned. The rapid development of vaccines has been breathtaking. Moving at least five times faster than ever before, the design, development, rigorous testing, and manufacture of multiple vaccines using different platforms have been astoundingly successful. This was only possible because of decades of investment in the long arc of technology development—working out the details of a messenger RNA strategy, for instance, was a 25-year journey. To prepare for future pandemics, we must extrapolate this lesson to the most likely pathogens lurking in the future. We should also learn from the experience of vaccine trial recruitment, where special efforts like the U.S. National Institutes of Health (NIH) Community Engagement Alliance (CEAL) were needed to reach out to communities of color, where the disease has taken its highest toll in the United States. Diversity in clinical trial enrollment is not just a nice idea—it is essential if the results are going to be meaningful to all groups. Therapeutics that have proven beneficial for COVID-19 include an antiviral (remdesivir), immunosuppressives (dexamethasone, baracitinib), several outpatient monoclonal antibodies, and anticoagulants. Important contributions were made by the Randomised Evaluation of COVID-19 Therapy (RECOVERY) trial in the United Kingdom and the Solidarity Trial sponsored by WHO. In the United States, a public-private partnership, Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), brought together government agencies, academics, and 20 pharmaceutical companies, ably managed by the Foundation for the NIH. With a priority on therapeutic agents, ACTIV designed master protocols and coordinated rigorous, well-powered randomized controlled trials. Operation Warp Speed, a public-private partnership initiated by the U.S. government, provided billions of dollars for trial operation and at-risk manufacturing. One lesson learned, however, was that many clinical trials in the United States were not initially well suited to a public health emergency. Far too many small and poorly designed trials (many focused on hydroxychloroquine, which turned out to be a dead end) were initiated in the early days of the pandemic—all with good intentions but contributing relatively little in terms of new knowledge. Another lesson is that the necessary short-term dependence on repurposing existing drugs will not often produce true successful outcomes. For the future, we should begin to work on potent oral antivirals against all major classes of potential pathogens, with the goal of having drugs ready for phase 2/3 efficacy trials when the next threat emerges. Another major challenge was the need for fast, widely accessible, and highly accurate virus testing. For all their merits, the first-arriving nucleic acid tests, which generally had to be conducted in central labs, took too long to produce the rapid results urgently needed to prevent spread. This inspired an innovative response—the NIH Rapid Acceleration of Diagnostics (RADx) program in which test developers drew on a “shark tank” of engineering, business, and manufacturing experts. From over 700 applications, 137 went through an intense evaluation, and those judged most promising were provided with additional resources. As a result, today there are 28 novel diagnostic platforms collectively contributing an additional 2.5 million tests daily. An analysis of the potential benefits of widespread home testing is about to get under way. This approach, whereby NIH took on the role of venture capitalist, should be considered in the future when rapid development of new technologies is the goal. In the past, the world has rallied to confront new pandemics, only to lapse into complacency as the risk faded. Having now experienced the worst pandemic in 103 years, we must not make that mistake again.

Vaccine efficacy probable against COVID-19 variants

By Science Magazine on 12/03/2021 00:00

The U.S. Food and Drug Administration (FDA) emergency use authorization of three vaccines, all of which have shown greater than 85% effectiveness against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (1–3), has provided the public with the hope of ending the global COVID-19 pandemic. However, recent outbreaks of more transmissible variant SARS-CoV-2 strains that harbor mutations in the spike protein—the critical viral target of immune responses produced by the vaccines ([ 1 ][1]–[ 3 ][2])—has invited a dour outlook on the vaccines’ continued efficacy ([ 4 ][3]). The trepidation is based on the prompt compilation of in vitro data that demonstrate as much as 10-fold reduction in neutralization antibody (NAb) activity in vaccinated samples against mutant spike protein pseudovirus ([ 5 ][4], [ 6 ][5]), which is thought to be an important metric of acquired immunity ([ 7 ][6]). Although reports of NAb reduction are alarming in magnitude, the proof of vaccine effectiveness can only be measured definitively by challenging vaccinated subjects with infection. Vaccine efficacy measured by infection challenge experiments using non-human primates is often prerequisite to clinical trials, but these data are seldom articulated in lay reports. For example, in the Moderna-1273 vaccine trial ([ 8 ][7]), nonhuman primates received a 10-microgram dose [10% of the dose recommended for humans by the FDA (9)] or a 100-microgram dose (100% of the FDA dose), and researchers found a mean NAb titer of about 300 or about 3500, respectively. Despite the difference in NAb levels, both doses conferred substantial protection from infection, as measured by viral particle titers and prevention of respiratory pathology. Similar data were obtained using the Pfizer ([ 10 ][8]) and Johnson & Johnson ([ 11 ][9]) vaccines. Importantly, vaccinated samples have been tested using pseudoviral particles that express each of the SARS-CoV-2 variant spike proteins, and in each case, the samples appear to exhibit NAb titers greater than 300 in vitro ([ 12 ][10]), suggesting that vaccines will be effective against mutant strains. These studies show that what appears to be magnitudes of difference in NAb activity may not necessarily correlate with clinical immunity. As variant strains emerge, we will need to reevaluate vaccine efficacy by testing the inhibition of viral infection in vivo rather than by quantifying the antibodies produced after in vitro exposure. Reliable proof of immunity through vaccination may only come through reinfection challenge experiments or through longitudinal studies of postvaccination subjects. 1. [↵][11]1. F. P. Polack et al ., N. Engl. J. Med. 383, 2603 (2020). [OpenUrl][12][CrossRef][13][PubMed][14] 2. 1. L. R. Baden et al ., N. Engl. J. Med. 384, 403 (2021). [OpenUrl][15][PubMed][14] 3. [↵][16]1. J. Sadoff et al ., N. Engl. J. Med. 10.1056/NEJMoa2034201 (2021). 4. [↵][17]1. A. S. Lauring, 2. E. B. Hodcroft , JAMA 325, 529 (2021). [OpenUrl][18] 5. [↵][19]1. M. S. Graham et al ., medRxiv, 10.1101/2021.01.28.21250680 (2021). 6. [↵][20]1. P. Wang et al ., bioRxiv, 10.1101/2021.01.25.428137 (2021). 7. [↵][21]1. L. A. VanBlargan, 2. L. Goo, 3. T. C. Pierson , Microbiol. Mol. Biol. Rev. 80, 989 (2016). [OpenUrl][22][Abstract/FREE Full Text][23] 8. [↵][24]1. K. S. Corbett et al ., N. Engl. J. Med. 383, 1544 (2020). [OpenUrl][25][PubMed][14] 9. ModernaTX, Inc., “Fact sheet for healthcare providers administering vaccine (vaccination providers)” (2020); [www.modernatx.com/covid19vaccine-eua/eua-fact-sheet-providers.pdf][26]. 10. [↵][27]1. A. B. Vogel et al ., bioRxiv, 10.1101/2020.09.08.280818 (2020). 11. [↵][28]1. N. B. Mercado , Nature 586, 583 (2020). [OpenUrl][29] 12. [↵][30]1. K. Wu et al ., bioRxiv, 10.1101/2021.01.25.427948 (2021). [1]: #ref-1 [2]: #ref-3 [3]: #ref-4 [4]: #ref-5 [5]: #ref-6 [6]: #ref-7 [7]: #ref-8 [8]: #ref-10 [9]: #ref-11 [10]: #ref-12 [11]: #xref-ref-1-1 “View reference 1 in text” [12]: {openurl}?query=rft.jtitle%253DN.%2BEngl.%2BJ.%2BMed.%26rft.volume%253D383%26rft.spage%253D2603%26rft_id%253Dinfo%253Adoi%252F10.1056%252FNEJMoa2034577%26rft_id%253Dinfo%253Apmid%252Fhttp%253A%252F%252Fwww.n%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [13]: /lookup/external-ref?access_num=10.1056/NEJMoa2034577&link_type=DOI [14]: /lookup/external-ref?access_num=http://www.n&link_type=MED&atom=%2Fsci%2F371%2F6534%2F1116.1.atom [15]: {openurl}?query=rft.jtitle%253DN.%2BEngl.%2BJ.%2BMed.%26rft.volume%253D384%26rft.spage%253D403%26rft_id%253Dinfo%253Apmid%252Fhttp%253A%252F%252Fwww.n%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [16]: #xref-ref-3-1 “View reference 3 in text” [17]: #xref-ref-4-1 “View reference 4 in text” [18]: {openurl}?query=rft.jtitle%253DJAMA%26rft.volume%253D325%26rft.spage%253D529%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [19]: #xref-ref-5-1 “View reference 5 in text” [20]: #xref-ref-6-1 “View reference 6 in text” [21]: #xref-ref-7-1 “View reference 7 in text” [22]: {openurl}?query=rft.jtitle%253DMicrobiology%2Band%2BMolecular%2BBiology%2BReviews%26rft.stitle%253DMicrobiol.%2BMol.%2BBiol.%2BRev.%26rft.aulast%253DVanBlargan%26rft.auinit1%253DL.%2BA.%26rft.volume%253D80%26rft.issue%253D4%26rft.spage%253D989%26rft.epage%253D1010%26rft.atitle%253DDeconstructing%2Bthe%2BAntiviral%2BNeutralizing-Antibody%2BResponse%253A%2BImplications%2Bfor%2BVaccine%2BDevelopment%2Band%2BImmunity%26rft_id%253Dinfo%253Adoi%252F10.1128%252FMMBR.00024-15%26rft_id%253Dinfo%253Apmid%252F27784796%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [23]: /lookup/ijlink/YTozOntzOjQ6InBhdGgiO3M6MTQ6Ii9sb29rdXAvaWpsaW5rIjtzOjU6InF1ZXJ5IjthOjQ6e3M6ODoibGlua1R5cGUiO3M6NDoiQUJTVCI7czoxMToiam91cm5hbENvZGUiO3M6NDoibW1iciI7czo1OiJyZXNpZCI7czo4OiI4MC80Lzk4OSI7czo0OiJhdG9tIjtzOjI1OiIvc2NpLzM3MS82NTM0LzExMTYuMS5hdG9tIjt9czo4OiJmcmFnbWVudCI7czowOiIiO30= [24]: #xref-ref-8-1 “View reference 8 in text” [25]: {openurl}?query=rft.jtitle%253DN.%2BEngl.%2BJ.%2BMed.%26rft.volume%253D383%26rft.spage%253D1544%26rft_id%253Dinfo%253Apmid%252Fhttp%253A%252F%252Fwww.n%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [26]: http://www.modernatx.com/covid19vaccine-eua/eua-fact-sheet-providers.pdf [27]: #xref-ref-10-1 “View reference 10 in text” [28]: #xref-ref-11-1 “View reference 11 in text” [29]: {openurl}?query=rft.jtitle%253DNature%26rft.volume%253D586%26rft.spage%253D583%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [30]: #xref-ref-12-1 “View reference 12 in text”