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A just published study by British investigators claims that not only infectivity of the “new” British B.1.1.7 SARS-CoV-2 strain, B.1.1.7, is higher than that of previously dominant strains, including D614G, but also mortality. A case-controlled study suggests a significant increase in deaths [1.64 (955 CI, 1.32 to 2.04], suggesting a 64% higher likelihood of death (range 32%-104%) (Challen et al., BMJ 2021;372:n579).
If confirmed, that would be an important finding; but we call for cautious interpretation of this data. First, such retrospective studies are always riddled with selection biases. But even more importantly, Israeli data, which at the present time are probably the most reliable large-scale data sets, have demonstrated significant declines in mortality, while simultaneously reporting that the British B.1.1.7 strain has become the dominant one in Israel. These two results are not necessarily contradictive, but even if the British report is accurate, the Israeli data suggest that large-scale vaccination will reduce mortality rates.
Rumors have been circulating that anti-COVID-19 vaccines can affect fertility. Recently a guidance was published by the Association of Reproductive and Clinical Scientists and the British Fertility Society, which in the clearest possible language states that, “there is absolutely no evidence” for such an association in either women or men (Iacobucci G. BMJ 2021;372:n509), confirming an earlier similar statement of the ACOG.
Pfizer-BioNTech finally announced a clinical trial of its COVID-19 vaccine in pregnant women. A total of 4,000 women are expected to participate. Vaccinations will be performed between 24-34 weeks gestational age in women above age 20. As in earlier trials, this will be a placebo-controlled study. Women, therefore, will not know whether they received vaccine or placebo. The exclusion of pregnant women from earlier trials has been criticized, because of the higher risk for severe diseases women experience if they get infected during pregnancy (Rubin R. JAMA. 2021 Feb 24. doi: 10.1001/jama. 2021.2264)
Laird Harrison just reported in www.medscape.com on March 10, 2021 that CDC surveillance data for the Pfizer-BioNTech and Moderna vaccines in over 30,000 women who reported pregnancies through the CDC’s V-Safe voluntary reporting system did not differ from controls (https://www.medscape.com/viewarticle/947211_print).
Since COVID-19 started, reporting news from the CDC has become tricky. Often announcements are being changed before the ink has even dried. We, therefore, have been increasingly careful in quoting these announcements. But two recent announcements have attracted our attention: The first went public not as a guidance but as a formal study, published by the CDC COVID-19 Response Team, Mitigation Policy Analysis Unit; CDC Public Health Law Program, in the CDC’s Morbidity and Mortality Weekly Report (MMWR) on March 5, 2021 (Guy Jr et al., MMWR 2021;70:-5). In that study, the investigators attempted to determine the impact of restaurant dining on COVID-19 infection rates, and their findings were surprising and not. Mask mandates were associated with decreasing daily COVID-19 cases and decreasing death rates within 20 days (expected). Indoor restaurant dining, was associated with increased daily COVID-19 cases after 41-100 days, and an increase in daily deaths after 61-100 days (surprising).
We found the latter result surprising because prior CDC data suggested that restaurants contributed only 1.4% of all new COVID-19 infections. Moreover, the very delayed and spread-out increase in infections also seems somewhat suspicious, suggesting that the investigators may have overlooked some confounders. But caution is, of course, always in place and we thought our readers should know about this study.
Also, The CDC for the first-time published guidance for people who had been vaccinated. The CDC recognizes “vaccinated” at the present time as those who received two shots of the Pfeizer or Moderna vaccines. Those lucky individuals now may feel a little safer than before, but to only limited degrees. Even for fully vaccinated individuals, the CDC still recommends against all travel and is maintaining a masking guidance when in public. Like the recent CDC guidance for school reopening, many experts again were critical of this recent guideline. They argued that, by being unnecessarily conservative in guidance, the CDC counteracts incentives for people to get vaccinated.
Considering all the criticism, we predict yet another update from the CDC soon, especially when it comes to airline travel.
When it comes to reporting news, one cannot help but pay attention when CNN announces that, “the U.S. could reach herd immunity (against COVID-19) by vaccination alone;”Updated, March 5, 2021 (https://us.cnn.com/2021/03/05/health/herd-immunity-usa-vaccines-alone/index.html). While we very much hope that CNN in this case is correct, scientifically we have serious doubt about the network’s expertise on the subject. But should CNN be right, kudos to them!
This is something we don’t recall ever having witnessed, - prominent representatives of ASRM and ESHRE publicly going at each other in a leading medical journal of the specialty. It all started with a paper in JARG by La Marca and Nelson (J.Assist Reprod Genet 2020;37:1832-1838) in which the authors attempted to summarize differences in testing recommendations for SARS-CoV-2 between the two organizations. Cristina M. Magli and Catherine Racowsky, at the time the president of ASRM, responded in a letter-to-the-editor at JARG by denying significant differences between the societies and accusing La Marca and Nelson of a ”quite superficial analysis” (J Assist Reprod Genet 2020;37:2653-2655) That, of course, did not go unanswered and LaMarca and Nelson responded with another letter-to-the editor (J Assist Reprod Genet 2021; 38:539-541).
Considering how quickly formal guidance on almost any issue regarding COVID-19 has changed over the last year, not only from ASRM and ESHRE but also from the CDC, this dispute appears minor and rather unimportant. We could easily think of more substantial issues ASRM and ESHRE might discuss, for example, their respective positions regarding shutting down IVF centers on both sides of the Atlantic at the beginning of the COVID-19 pandemic.
We, indeed, applaud Scott Nelson and Antonio La Marca when in their most recent communication they say, “as scientists we should acknowledge uncertainty, debate the interpretation of emerging evidence and encourage scientific discourse and rigor regarding the relative merit of any specific guidance, especially if disparate approaches are recommended.” If COVID-19 has taught us anything, then it is humility. Knowledge constantly changes, and with it, the “relative scientific truth of the moment.”
Norbert Gleicher, MD, leads CHR’s clinical and research efforts as Medical Director and Chief Scientist. A world-renowned specialist in reproductive endocrinology, Dr. Gleicher has published hundreds of peer-reviewed papers and lectured globally while keeping an active clinical career focused on ovarian aging, immunological issues and other difficult cases of infertility.
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