We all want COVID-19 protection for our communities and beyond, but as promising as the vaccines now in use are, out of millions of doses, what the industry calls “adverse advents” happen. Most are minor and transient as we have chronicled thus far, but some of these negative reactions can lead directly to death. It is critical for public health decisions to know adverse events so they can be weighed against the benefits of, e.g., a vaccine. Now over 30,000 folks in Norway have gotten the first shot of either the Pfizer or Moderna vaccine products since late December. On January 15, the New York Post reported on 23 deaths in Norway among vaccine recipients. The unlucky patients died within days of getting their first does of the Pfizer COVID-19 vaccine, and 13 of the deaths, which all occurred in nursing homes, were “apparently related to the side effects of the shots,” according to health officials. Sigurd Hortemo, who is chief doctor at eh Norwegian Medicines Agency, said Friday that the common reactions of fever and nausea, “may have contributed to the fatal outcome in some frail patients.”
Frailest Most At Risk
The dead were all at least 80-years-old and above. While not “expressing serious concern,” officials are adjusting their guidance on who should be vaccinated. “We are not alarmed by this,” said Steinar Madsen, who is the medical director for the Agency. “It is quite clear that these vaccines have very little risk, with a small exception for the frailest patients—Doctors must now carefully consider who should be vaccinated,” he opined.
“Those who are very frail and at the very end of life can be vaccinated after an individual assessment.” Besides the deceased, nine subject have serious side effects such as allergic reactions, “strong discomfort,” and high fever, “while seven had less serious ones, including severed pain at the injection site.” Per Johns Hopkins University, Norway has had 57,000 COVID-19 cases and 500 deaths. Pfizer has weighed in, with a reps saying that the company is “aware of reported deaths” and is working with the Medicines Agency, “to gather all relevant information—Norwegian authorities have prioritized the immunization of residents in nursing homes, most of whom are very elderly with underlying medical conditions and some which are terminally ill—[The Norwegian Medicine Agency confirms] the number of incidents so far is not alarming, and in line with expectations.”
A Death in Florida
Back on January 12, the New York Times looked at the case of a doctor who died after a COVID-19 vaccine. The Florida doctor got severe case of a blood disorder just after getting the Pfizer vaccine product, and “It is not yet known if the shot is linked to the illness.” The deceased passed away 16 days after vaccination. The man in question is Gregory Michael, MD, “a 56-year-old obstetrician and gynecologist in Miami Beach.” He got the vaccine at the Mount Sinai Medical Center on December 18 and, “died 16 days later from a brain hemorrhage, his wife, Heidi Neckelmann, wrote in a Facebook post.” Early after vaccination, Michael developed, “extremely serious form of a condition known as acute immune thrombocytopenia, which prevented his blood from clotting properly.” Pfizer, for its part, has offered that it was “actively investigating” the death, “but we don’t believe at this time that there is any direct connection to the vaccine.”
In a bit of technical language, Pfizer notes that, “There have been no related safety signals identified in our clinical trials, the post-marketing experience thus far,” or with the newer tech used for this product, the firm offered. “Our immediate thoughts are with the bereaved family.” Around nine million [as of January 12] in the US have gotten at least one vaccine shot, either the Pfizer or Moderna version.
As of the Times article, major problems with the vaccines consisted of 29 cases of anaphylaxis or severe allergic reaction. None of these, “were reported as fatal.”
Many patients have had transient side effects like sore arms, fatigue, or a headache. Both federal and local agencies are looking into Michaels’s death, and “experts said the case was highly unusual but could have been a severe reaction to the vaccine.” Florida’s Department of Health referred the case to the CDC for investigation, and the later agency’s Kristen Nordlund offered in a statement that the department would, “evaluate the situation as more information becomes available and provide timely updates on what is known and any necessary actions.”
Things Will Happen
Ms. Neckelmann reported that she told her story to raise awareness of the vaccine’s possible “side effects,” and “that it is not good for everyone, and in this case destroyed a beautiful life, a perfect family, and has affected so many people in the community.” Johns Hopkins’ blood disorder expert Dr. Jerry L. Spivak said that judging from the descriptions given, “I think it is a medical certainty that the vaccine was related—-This is going to be very rare,” opined Dr. Spivak, an emeritus professor of medicine. He added, “It happened and it could happen again.” Spivak said the reaction was “idiosyncratic,” i.e., without known cause and likely based on genetics. “If you vaccinate enough people, things will happen,” he offered. Quoting the NYT, “Vaccines stimulate the immune system, and in theory could, in rare cases, cause it to mistakenly identify some of a patient’s own cells as enemy invaders that should be destroyed.”
Real World Tracking: Pfizer Vaccine Shines
TrialSite reported on what appears to be an overall positive safety record thus far, based on reported data from the CDC’s Vaccine Adverse Event Reporting System (VAERS).
Of course, the clinical trial data has its share of limitations hence the importance of the real time data reporting system, that is mounting real world evidence.
Recognizing that the trial data focused on relative risk, with an emphasis on severity and not necessarily the vaccine’s proclivity to save life, nor for that matter the efficacy in critically sensitive cohorts such as those elderly and in poor health, exampled by nursing home residents. The clinical trial results were captured at a time shortly post vaccination; but little is known about how any COIVD-19 vaccine performs for example half a year to a year in the future.
Hence at least for now comparative efficacy data (e.g. compared to other vaccination data such as the standard flu shots) is not necessarily straightforward. And, of course, other groups are now just under study such as adolescents and teenagers while those with challenged immune systems were mostly left out of the Phase 3 clinical trials.
Jingoistic Badgering Continues
Interestingly, at least one Chinese media outlet recently asked why the U.S. press wasn’t covering the vaccine death story out of Norway. The Chinese press via Global Times blamed “US and British media” of “putting geopolitical labels on vaccines” and “meddling in political stances with the scientific attitude toward vaccines, using their propaganda to promote Pfizer vaccines and smearing Chinese vaccines.”
At least in this case, the press in China actually just “projects” what is in all actuality a far more censored and suppressed reality than is anything close to the West and particularly, in the Anglosphere—that is America and Britain as two prominent examples, where as compared to China, pretty much anything goes when it comes to the media.
Of course, there are a few of the largest media corporations that are heavily influenced and directed by advertisers but then there’s the NY Post with their provocative headlines, and thousands of outlets online such as this notable one to choose from. Consumers can access pretty much access any news they seek out in America or Britain, should they desire to do so. Unfortunately, for the Chinese people, this isn’t the reality at all.
The Global Times correctly shared that all of the vaccines were developed in a “relatively hasty” manner, however what they fail to disclose, and in fact cannot due to censorship, is the significant rigor (and associated complexity and cost) associated with any vaccine testing done within the U.S. jurisdiction, where the Food and Drug Administration (FDA), the gold standard for all drug regulatory agencies, requires all emergency authorized vaccines to have gone through substantial Phase 3 clinical trials involving around 30,000 patients for each study.
What was allowed in China is frankly not even comparable. None of the Chinese vaccines were required to go through lengthy, costly and complex Phase 3 clinical trials in that nation prior to actual authorization of use to substantial numbers of the population.
That’s right, just like was the case in Russia with Sputnik V, the authorities allowed the drug companies to distribute unfinished vaccines to significant numbers of their people under the auspices of emergency use. Vaccine manufacturers in the U.S. as well as in Europe had a far higher set of standards to meet, and continue to do so to distribute any medicine or vaccine. We add that at least in the U.S. and Europe, vaccine makers have shared unprecedented levels of data, disclosing protocols and the like. Moreover, the efficacy data associated with Moderna and Pfizer are unparalleled at 94% and 95% respectively.