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In an early analysis of coronavirus vaccine safety data, researchers at the Centers for Disease Control and Prevention have found no evidence that the Pfizer-BioNTech or Moderna vaccines pose serious risks during pregnancy. The findings are preliminary and cover just the first 11 weeks of the U.S. vaccination program. But the study, which included self-reported data on more than 35,000 people who received one of the vaccines during or shortly before pregnancy, is the largest yet on the safety of the coronavirus vaccines in pregnant people. During the clinical trials of the vaccines, pregnant women were excluded. That left patients, doctors and experts unsure whether the shots were safe to administer during pregnancy. “There’s a lot of anxiety about whether it’s safe and whether it would work and what to expect as far as side effects,” said Dr. Stephanie Gaw, a maternal-fetal medicine specialist at the University of California, San Francisco. The new data, Dr. Gaw said, demonstrate that “a lot of pregnant people are getting the vaccine, there isn’t a significant increase in adverse pregnancy effects at this point, and that side effect profiles are very similar to nonpregnant people.” “I think that’s all very reassuring,” she said, “and I think it will really help providers and public health officials more strongly recommend getting the vaccine in pregnancy.” Covid-19 poses serious risks during pregnancy. Pregnant women who develop symptoms of the disease are more likely to become seriously ill, and more likely to die, than nonpregnant women with symptoms.Beca use of those risks, the C.D.C. has recommended that coronavirus vaccines be made available to pregnant women, though it also suggests that they consult with their doctors when making a decision about vaccination. The new study, which was published on Wednesday in The New England Journal of Medicine, is based largely on self-reported data from V-safe, the C.D.C.’s coronavirus vaccine safety monitoring system. Participants in the program use a smartphone app to complete regular surveys about their health, and any side effects they might be experiencing, after receiving a Covid-19 vaccine. The researchers analyzed the side effects reported by V-safe participants who received either the Pfizer or Moderna vaccine between Dec. 14, 2020, and Feb. 28, 2021. They focused on 35,691 participants who said that they had been pregnant when they received the vaccine or became pregnant shortly thereafter. After vaccination, pregnant participants reported the same general pattern of side effects that nonpregnant ones did, the researchers found: pain at the injection site, fatigue, headaches and muscle pain. Women who were pregnant were slightly more likely to report injection site pain than women who were not, but less likely to report the other side effects. They were also slightly more likely to report nausea or vomiting after the second dose. Pregnant V-safe participants were also given an opportunity to enroll in a special registry that tracked pregnancy and infant outcomes. By the end of February, 827 of those enrolled in the pregnancy registry had completed their pregnancies, 86 percent of which resulted in a live birth. Rates of miscarriage, prematurity, low birth weight and birth defects were consistent with those reported in pregnant women before the pandemic, the researchers report. “This study is of critical importance to pregnant individuals,” Dr. Michal Elovitz, a maternal-fetal medicine specialist at the University of Pennsylvania, said in an email. “It is very reassuring that there were no reported acute events in pregnant individuals” over the course of the study, she said. But the report has several limitations and much more research is needed, experts said. Enrollment in the surveillance programs is voluntary and the data are self-reported. In addition, because the study period encompassed just the first few months of the U.S. vaccination campaign, the vast majority of those enrolled in the pregnancy registry were health care workers. And there is not yet any data on pregnancy outcomes from people who were vaccinated during the first trimester of pregnancy. “I think we can feel more confident about recommending the vaccine in pregnancy, and especially with pregnant people that are at risk of Covid,” Dr. Gaw said. “But we do need to wait for more data for complete pregnancy outcomes from vaccines early in pregnancy.” Findings published in NEJM (April 21, 2021): https://doi.org/10.1056/NEJMoa2104983
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More people taking Moderna’s coronavirus vaccine reported side effects than those who got the Pfizer shot, according to a recent study. Researchers analyzed reports from more than 3 million vax recipients collected via v-safe, a Centers for Disease Control and Prevention program that tracks reactions to the immunizations. Nearly 70 percent said they had some kind of injection site reaction, like pain or swelling, and half reported general side effects like fatigue or chills, the study found. “A greater percentage of participants who received the Moderna vaccine, compared with the Pfizer-BioNTech vaccine, reported reactogenicity; this pattern was more pronounced after the second dose,” the researchers noted. Of those who got the Moderna shot, 73 percent said they had an injection site reaction, compared with 65 percent of people who got Pfizer’s vaccine, the study found. Nearly 51 percent of Moderna recipients reported experiencing full-body symptoms, compared with 48 percent of those who got the Pfizer shot. The reports came from more than 3.6 million people who got their first dose of a COVID-19 vaccine before Feb. 21 and completed at least one health survey on v-safe within seven days of getting jabbed. The gap widened after the second dose, according to the reports from about 1.9 million people who completed those check-ins after receiving shot No. 2, the study said. Close to 82 percent of people who got their second Moderna vaccine had injection site pain, compared to under 69 percent of those with Pfizer. Overall, 74 percent of Moderna recipients said they experienced full-body symptoms, versus 64 percent of people who got the Pfizer vax. Some 40 percent of people with Moderna specifically reported getting chills, compared with just 22 percent of Pfizer recipients. “Data from millions of v-safe participants indicate that injection site pain is common after both the first and second doses of either mRNA-based vaccine,” the researchers noted. The study was published Monday in the peer-reviewed medical journal JAMA.. Findings published in JAMA (April 5, 2021): https://doi.org/10.1001/jama.2021.5374
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The Prime Minister of Norway, Erna Solberg, says her country may fine-tune the vaccination of its oldest, sickest citizens as it tries to make sense of a recent spate of deaths. Having weathered the pandemic better than most, Norway suddenly made international headlines this month after revealing that more than 30 people -- all over 70 and all already sick -- died not long after being vaccinated against Covid-19. Solberg says the intense global interest in the news was “exaggerated” as she tries to ensure the development doesn’t put people off inoculation. “We don’t believe there’s any problem with the safety of the vaccines,” Solberg said in an interview with Bloomberg Live that aired on Tuesday. “But we will maybe not give them to the most vulnerable of the elderly, because that might speed up a process where they were what we would say at the end of life phase anyway,” so, “that probably is not what we will continue to do.” The Norwegian Institute of Public Health, which has identified people over 65 as a group to be prioritized in the vaccine rollout, has urged doctors to inoculate the elderly and sick on a case-by-case basis. “For very frail patients and terminally ill patients, a careful balancing of benefit versus disadvantage of vaccination is recommended,” it said on Jan. 11, before Norway published data on post-inoculation deaths. The Norwegian Medicines Agency said its reporting on adverse reactions caused unnecessary concern around the world, and will now only publish data on deaths that have been autopsied. The agency says its information on the side-effects of Covid-19 vaccines will be included in international studies. Other countries, including Germany, have also recorded deaths in people who recently were vaccinated. Finland reported three such fatalities on Tuesday, but none of the countries identified causal links. The Norwegian Medicines Agency says there’s no evidence so far that the elderly deaths reported were directly linked to the vaccine. “However, it cannot be ruled out that common vaccine side effects, such as fever and nausea, may have contributed to a serious course of underlying disease in frail patients,” the agency said in a written response to questions. Norway is now working with Pfizer Inc. and BioNTech SE -- the first producers to provide it with vaccines -- to examine its data in more detail. The country’s medicines agency has told Pfizer it doesn’t see grounds for alarm. The first Europe-wide safety report on the Pfizer-BioNTech vaccine is due to be published at the end of January. Meanwhile, Norway’s government has underscored its confidence in the vaccine. “We are trying to work very hard to get the focus that this is not a problem,” Solberg said. “It’s who we have vaccinated, not the vaccine that has created this data.” Norway’s medicines agency reported 292 suspected “adverse reactions” out of 71,971 people who had been vaccinated as of Jan. 21; of those, 104 had been reviewed by health authorities, with 30 reported deaths. The country had inoculated 1.4% of its population as of Friday, according to Bloomberg’s Covid-19 Vaccine Tracker. That compares with 3.4% in neighboring Denmark, which is among the furthest advanced in Europe with its immunization program. Norway plans to administer second vaccine doses without delay, Solberg said. That’s in contrast to the approach in the U.K., where Health Secretary Matt Hancock has said there’s high confidence the first dose provides “decent efficacy” against the virus. Solberg spoke with Bloomberg Live before Norway moved to lock down the Oslo area in an effort to fight the spread of more contagious coronavirus mutations, deploying its strictest measures yet. The prime minister said she hopes Norway will finish vaccinating its most vulnerable citizens by March.
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California’s top epidemiologist is warning health providers to delay using a batch of the Moderna COVID-19 vaccine after a “higher-than-usual number of possible allergic reactions” were reported at a Southern Calfiornia vaccination clinic. The affected lot includes 330,000 doses — roughly 1/10th of what the state so far has distributed. The reaction was observed in fewer than 10 people who required medical attention after receiving the vaccine at one clinic, state epidemiologist Dr. Erica S. Pan said in a statement Sunday night. The conditions of those affected were not released, but health officials described the allergic reaction as “severe.” The clinic is located in San Diego, the California Department of Public Health reported later. “Out of an abundance of caution and also recognizing the extremely limited supply of vaccine,” read the statement, “we are recommending that providers use other available vaccine inventory and pause the administration of vaccines from Moderna Lot 041L20A until the investigation by the CDC, FDA, Moderna and the state is complete.” More than 330,000 doses from the affected lot — which arrived in California between Jan. 5 and Jan. 12 — have been distributed to 287 providers across the state, officials said. No other adverse reactions have been reported from that specific lot. “There are not immediate replacement doses during the pause in addition to pending orders scheduled for shipment in the next few days,” public health officials said in the statement sent to health providers. The health department said they would have more information later this week. Michael Williams is a San Francisco Chronicle staff writer. Email: michael.williams@sfchronicle.com
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Safety has been a paramount concern since AstraZeneca paused tests of the vaccine it's co-developing with the University of Oxford following an adverse event in a U.K. Researchers monitoring Pfizer Inc.’s giant trial of an experimental COVID-19 vaccine have reported no safety problems even after more than 12,000 people received their second of two doses. “So far there has been no safety signal reported,” said Mikael Dolsten, Pfizer’s chief scientific officer, in an online meeting with investors. The trial, now targeted at enrolling 44,000 people, has reached its initial goal of 30,000 subjects, Pfizer executives said. The drugmakers have expanded the trial to to allow inclusion of teenagers and people with certain medical conditions, like HIV. The trial compares two shots of the vaccine Pfizer is co-developing with Germany’s BioNTech SE to two doses of a placebo. While the doctors and subjects in the trial don’t know who got the vaccine — a measure to avoid bias — a committee of outside experts that knows which people received the shot is reviewing safety data on a weekly basis, Pfizer executives said during the investor meeting. “They would notify us if they had any safety concerns and have not done that to date,” Kathrin Jansen, Pfizer’s head of vaccine research, said during the meeting. The company’s own scientists are also looking for worrisome adverse events that haven’t appeared so far. Fatigue has been the most common side effect seen in the trial thus far, according to the Pfizer presentation. Pfizer confirmed it expects to get conclusive data on the vaccine’s efficacy by the end of October. The board monitoring the trial will conduct its first review of the data for efficacy when a total of 32 coronavirus cases have been seen among participants, Pfizer executives said during the investor meeting.
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Herpes infections may be a side effect of the COVID-19 vaccine, experts have revealed. Scientists in Israel identified six cases in a new study of patients developing a skin rash known as herpes zoster after receiving the Pfizer vaccine, according to a study in the Rheumatology journal. Herpes zoster starts off as a small, itchy skin rash, but if left untreated, it could cause nerve damage and pain, the Jerusalem Post reported. This can include a prolonged burning sensation on the skin even after the rash disappears. Researchers from Tel Aviv Sourasky Medical Center and Carmel Medical Center in Haifa found those with autoimmune inflammatory rheumatic diseases had a higher risk of developing the herpes. Out of 491 patients, six people or 1.2 percent experienced the infection, researchers said. The six patients all have mild cases of autoimmune inflammatory rheumatic diseases and were young, though the infection is generally more common in those over the age of 50. “That is why we reported on it,” Dr. Victoria Furer, the lead author, told the outlet. Five of them developed herpes zoster after the first dose and the sixth got it after the second. But it’s still unclear whether the vaccine caused the cases of herpes zoster. “We cannot say the vaccine is the cause at this point,” Furer told the outlet. “We can say it might be a trigger in some patients.” “We should not scare people,” she told the Jerusalem Post. “The overall message is to get vaccinated. It is just important to be aware.” Original research published in Rheumathology (April 12, 2021): https://doi.org/10.1093/rheumatology/keab345
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North Carolina and Colorado sites were temporarily shut down after several people suffered reactions. The race to vaccinate hit more roadblocks on Thursday, as several patients at a mass vaccination site in North Carolina suffered immediate reactions to the Johnson & Johnson shot. A day earlier, 11 people had adverse reactions in Denver, ranging from dizziness to nausea. Both sites temporarily shut down. "At this point we have no reason to believe there's anything wrong with the vaccine itself," said Dr. Shauna Gulley, a Centura Health chief clinical officer. "This is a temporary pause of one brand of vaccine so that we can investigate further." The news comes as distribution of the Johnson & Johnson vaccine is expected to fall 85% next week due in part to a factory mix-up. Meanwhile, the Midwest is on the verge of a relapse. In the last week, COVID-19 hospitalizations increased 11% on average among adults under 50 compared to the prior week. But in the Midwest, those hospitalizations jumped 42%. The hardest hit state is Michigan, where one doctor tweeted a desperate plea on Thursday. "We need some help," Dr. Justin Dimick wrote. Variants continue to complicate the country's recovery. Of all new coronavirus cases last week, children accounted for roughly one in five. Children are especially susceptible to the variant first found in the U.K., which was discovered at a recent outbreak at a Wisconsin childcare center. "Prior to this time, young kids, particularly those in eighth grade or younger, rarely got infected or seriously ill with the virus and importantly did not transmit the virus in the community. Today that has been turned on its head," said Dr. Michael Osterholm, the director of the Center for Infectious Disease Research and Policy. It's hitting college students, too. The University of Chicago said 50 students have tested positive. Some cases were linked to fraternity parties. In small-town Villa Grove, Illinois, a bar's indoor opening event was linked to 46 cases in February, spanning eight households. That led to the hospitalization of an elderly resident and forced a school to temporarily close, impacting 650 students. "Mask use was inconsistent and that six feet of distance was not maintained," said Centers for Disease Control and Prevention Director Rochelle Walensky. "These findings underscore the vast impact of a single event."
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Anaphylaxis was rarely reported among the first 4 million recipients of the second COVID-19 vaccine authorized for use in the United States, the CDC and FDA reported in MMWR. According to the report, between Dec. 21 and Jan. 10, more than 1,200 adverse events were reported following vaccination with Moderna’s COVID-19 vaccine. Of these, 108 were determined to be allergic reactions and 10 were confirmed as cases of anaphylaxis — equating to 2.5 cases per million doses administered — according to data compiled from the Vaccine Adverse Event Reporting System. The report outlined that nine of the cases of anaphylaxis were reported among people with a documented history of allergies or allergic reactions, including five with a history of anaphylaxis. According to the report, the median time between vaccine receipt to symptom onset was 7.5 minutes but ranged from anywhere between 1 and 45 minutes. Of the eight individuals with follow-up information available, all reportedly recovered or had been discharged home. “Based on this early monitoring, anaphylaxis after receipt of Moderna COVID-19 vaccine appears to be a rare event; however, comparisons of anaphylaxis risk with that associated with non–COVID-19 vaccines are constrained at this time by the limited data available this early in the COVID-19 vaccination program,” members of the CDC COVID-19 Response Team and the FDA wrote in the report. Moderna’s vaccine was the second COVID-19 shot authorized for emergency use in the U.S. Earlier this month, the CDC and FDA reported that the first vaccine, developed by Pfizer and BioNTech COVID-19, also was rarely associated with anaphylaxis, with 21 cases of confirmed among the first 1,893,360 recipients of the vaccine. At the time, Nancy E. Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases, said the number “may seem high, but this is still a rare outcome.” As a precaution, researchers said that vaccination sites should be outfitted to handle these reactions should they arise, and the CDC has issued updated interim clinical considerations to reflect that. “Locations administering COVID-19 vaccines should adhere to CDC guidance, including screening recipients for contraindications and precautions, having necessary supplies and staff members available to manage anaphylaxis, implementing recommended postvaccination observation periods, and immediately treating suspected anaphylaxis with intramuscular epinephrine injection,” the authors of the new report wrote. CDC report (Jan.22, 2021) available at:
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LONDON (AP) — Britain’s medical regulator warned Wednesday that people with a history of serious allergic reactions shouldn’t receive the COVID-19 vaccine from Pfizer and BioNTech as investigators look into whether two reactions on the first day of the country’s vaccination program were linked to the shot. Professor Stephen Powis, medical director for National Health Service in England, said the advice was issued on a “precautionary basis” and that the people who had reactions had recovered. Pfizer and BioNTech said they were working with investigators “to better understand each case and its causes.″ In the meantime, the Medical and Healthcare Products Regulatory Agency has said people should not received the vaccine if they have had a significant allergic reaction to a vaccine, medicine or food, such as those who have been told to carry an adrenaline shot — such as an EpiPen — or others who have had potentially fatal allergic reactions. The medical regulator also said vaccinations should be carried out only in facilities that have resuscitation equipment. Such advice isn’t uncommon; several vaccines already on the market carry warnings about allergic reactions, and doctors know to watch for them when people who’ve had reactions to drugs or vaccines in the past are given new products. The two people who reported reactions were NHS staff members who had a history of significant allergies and carried adrenaline shots. Both had serious reactions, but recovered after treatment, the NHS said. Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene & Tropical Medicine, said the regulator had done the right thing, but the general public shouldn’t be worried about getting the vaccine....
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A research trial of coronavirus patients in Brazil ended after patients taking a higher dose of chloroquine, one of the drugs President Trump has promoted, developed irregular heart rates. A small study in Brazil was halted early for safety reasons after coronavirus patients taking a higher dose of chloroquine developed irregular heart rates that increased their risk of a potentially fatal heart arrhythmia. Chloroquine is closely related to the more widely used drug hydroxychloroquine. President Trump has enthusiastically promoted them as a potential treatment for the novel coronavirus despite little evidence that they work, and despite concerns from some of his top health officials. Last month, the Food and Drug Administration granted emergency approval to allow hospitals to use chloroquine and hydroxychloroquine from the national stockpile if clinical trials were not feasible. Companies that manufacture both drugs are ramping up production. The Brazilian study involved 81 hospitalized patients in the city of Manaus and was sponsored by the Brazilian state of Amazonas. It was posted on Saturday at medRxiv, an online server for medical articles, before undergoing peer review by other researchers. Because Brazil’s national guidelines recommend the use of chloroquine in coronavirus patients, the researchers said including a placebo in their trial — considered the best way to evaluate a drug — was an “impossibility.” Despite its limitations, infectious disease doctors and drug safety experts said the study provided further evidence that chloroquine and hydroxychloroquine, which are both used to treat malaria, can pose significant harm to some patients, specifically the risk of a fatal heart arrhythmia. Patients in the trial were also given the antibiotic azithromycin, which carries the same heart risk. Hospitals in the United States are also using azithromycin to treat coronavirus patients, often in combination with hydroxychloroquine. Preprint of the Study available in medRxiv (April 11, 2020): https://www.medrxiv.org/content/10.1101/2020.04.07.20056424v1
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