Vaccine safety
Preliminary Findings of Covid-19 Vaccine Safety in Pregnant People Initial findings did not show obvious safety signals among pregnant people, but larger studies are recommended.
Many pregnant persons in the United States are receiving coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. From December 14, 2020, to February 28, 2021, we used data from the “v-safe after vaccination health checker” surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons.
RESULTS
A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases).
CONCLUSIONS
Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.
MONITORING SYSTEMS AND COVERED POPULATIONS
V-safe Surveillance System and Pregnancy Registry
V-safe is a new CDC smartphone-based active-surveillance system developed for the Covid-19 vaccination program; enrollment is voluntary. V-safe sends text messages to participants with weblinks to online surveys that assess for adverse reactions and health status during a postvaccination follow-up period. Follow-up continues 12 months after the final dose of a Covid-19 vaccine. During the first week after vaccination with any dose of a Covid-19 vaccine, participants are prompted to report local and systemic signs and symptoms during daily surveys and rank them as mild, moderate, or severe; surveys at all time points assess for events of adverse health effects. If participants indicate that they required medical care at any time point, they are asked to complete a report to the VAERS through active telephone outreach.
To identify persons who received one or both Covid-19 vaccine doses while pregnant or who became pregnant after Covid-19 vaccination, v-safe surveys include pregnancy questions for persons who do not report their sex as male. Persons who identify as pregnant are then contacted by telephone and, if they meet inclusion criteria, are offered enrollment in the v-safe pregnancy registry. Eligible persons are those who received vaccination during pregnancy or in the periconception period (30 days before the last menstrual period through 14 days after) and are 18 years of age or older. For persons who choose to enroll, the pregnancy registry telephone-based survey collects detailed information about the participant, including medical and obstetric history, pregnancy complications, birth outcomes, and contact information for obstetric and pediatric health care providers to obtain medical records; infants are followed through the first 3 months of life. Details about v-safe and v-safe pregnancy registry methods have been published previously.10,11
OUTCOMES
V-safe outcomes included participant-reported local and systemic reactogenicity to the BNT162b2 (Pfizer–BioNTech) vaccine and the mRNA-1273 (Moderna) vaccine on the day after vaccination among all pregnant persons 16 to 54 years of age and among nonpregnant women 16 to 54 years of age as a comparator. For analysis of pregnancy outcomes in the v-safe pregnancy registry, data were restricted to completed pregnancies (i.e., live-born infant, spontaneous abortion, induced abortion, or stillbirth). Participant-reported pregnancy outcomes included pregnancy loss (spontaneous abortion and stillbirth) and neonatal outcomes (preterm birth, congenital anomalies, small size for gestational age, and neonatal death) (Table S1 in the Supplementary Appendix, available with the full text of this article at NEJM.org). In the VAERS, outcomes included non–pregnancy-specific adverse events and pregnancy- and neonatal-specific adverse events.
STATISTICAL ANALYSIS
Demographic information and pregnancy characteristics are described for both v-safe and VAERS participants. Descriptive analyses were performed with the use of v-safe survey data for persons who identified as pregnant through February 28, 2021 (35,691 persons); persons enrolled in the v-safe pregnancy registry who were vaccinated through February 28, 2021 (3958 persons); and VAERS reports involving pregnant women received through February 28, 2021 (221 persons). Local and systemic reactogenicity was compared between persons who identified as pregnant and nonpregnant women. Descriptive analyses were conducted with the use of SAS software, version 9.4 (SAS Institute). All activities were reviewed by the CDC and were conducted in accordance with applicable federal law and CDC policy.
The vaccine uses tried and true science with a proven track record of safety It uses the same technology as the popular Flublok influenza vaccine and the hepatitis B vaccine, which have been used safely by huge numbers of people for numerous years.
Some people have claimed that the Novavax vaccine used a new type of technology that hasn’t been proven safe based on past use. This is false. MedPage Today explains:
Novavax’s COVID-19 vaccine candidate could be the first authorized or approved in the U.S. to rely on a “tried and true” method for immunizing people against coronavirus.
This purified protein, or protein subunit, vaccine strategy is used in many other vaccines on the market today — so does it have a role to play in easing hesitancy to COVID vaccines?
Experts in public health, infectious diseases, and vaccinology interviewed by MedPage Today said that while there are some notable caveats, it’s certainly possible that having the option could help, and that they’d welcome anything that would get more people rolling up their sleeves.
For Novavax’s protein subunit vaccine candidate (known as NVX-CoV2373), spike protein is made by infecting cultures of insect (Spodoptera frugiperda) cells with a baculovirus that’s been altered to contain genes for making the spike. The cells then churn out spike proteins, which are purified and mixed with an adjuvant to make the vaccine.
The Novavax candidate contains the “Matrix-M” adjuvant, which is composed of the plant-derived glycoside saponin, cholesterol, and phospholipids.
Paul Offit, MD, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said this is the exact same technology used in the Flublok influenza vaccine, and is similar to other purified protein vaccines that have been around for a long time, like the hepatitis B vaccine.
Other COVID-19 vaccines using more traditional technology are in development or in use in other countries, though it’s not clear they’ll become available in the U.S.
William Schaffner, MD, an infectious disease expert at Vanderbilt University Medical Center in Nashville, said there could be an advantage in the emotional appeal of a vaccine strategy with an apparent track record.
“Psychologists tell us that facts are essential, but what changes behavior is how people feel about something,” Schaffner told MedPage Today. “They have to feel comfortable and reassured. … Anything that will persuade some people to make them feel more comfortable in accepting a vaccine is something I endorse.”
The spike proteins from Covid vaccines are safe Spike proteins have been used in many vaccines. They mimic a small part of the virus to train the immune system to recognize and beat the virus.
As reported by First Draft News, here is one falsehood being spread:
Some anti-vaccine conspiracy theorists responded to the Novavax US phase 3 trial data by repeating the false narrativethat spike proteins — the mechanism by which the Novavax and other vaccines produce an immune response — are harmful. “Novavax injection just dumps millions of spike proteins right into your body. Can’t wait to see all the myocarditis from that,” reads a tweet from Dr. Jane Ruby, who describes herself as a medical expert and who recently amplified the false claim that Covid-19 vaccines induce magnetism.
To see the whole article, click here. Here’s a clip from Politifact that rebuts this falsehood:
There’s no evidence to support the claim that spike protein is dangerous. The spike proteins produced as a result of vaccination help stimulate the body’s defenses against COVID-19. The U.S. Centers for Disease Control and Prevention calls them “harmless.”
Ruby, whose Twitter account identifies her as “Dr. Jane Ruby,” is not a medical doctor. She describes herself as a health economist and “New Right political pundit” with a doctorate in psychology. Her LinkedIn profile shows he has a background in pharmaceutical research and nursing.
We messaged Ruby via Twitter but didn’t get a reply.
We have fact-checked other spike protein claims, finding that there is no evidence they present any serious health risk on their own.
We rated False a claim by Canadian viral immunologist Byram Bridle that the COVID-19 vaccines’ spike protein means people are being inoculated “with a toxin.” Experts said there is no evidence that the vaccines produce a toxin that could cause heart problems and neurological damage, as Bridle alleged.
We also rated False a claim that COVID-19 vaccines’ “spike protein is very dangerous, it’s cytotoxic,” which means toxic to cells. U.S. public health authorities and vaccine experts said there is no evidence that the vaccines’ spike protein is toxic or “cytotoxic.”
The protein-based Novavax vaccine is similar in its approach to the influenza vaccine Flublok, containing a single viral protein, the SARS-CoV-2 surface protein, said Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a member of the U.S. Food and Drug Administration’s vaccine advisory committee.
“This protein has not been shown to be dangerous,” he said. “It’s just a single viral protein similar to the hepatitis B and human papillomavirus vaccines, and are remarkably safe.”
“The SARS-CoV-2 virus, on the other hand, reproduces itself thousands of times, and is incredibly dangerous.”
The National Institutes of Health said data from the trial “indicate the investigational vaccine was generally well-tolerated.” The most common side effects were mild to moderate pain at the injection site, fatigue, headache and temporary muscle pain. We rate the post False.
To read the full article, go here.
Preliminary Findings of Covid-19 Vaccine Safety in Pregnant People Initial findings did not show obvious safety signals among pregnant people, but larger studies are recommended.
Initial findings did not show obvious safety signals among pregnant people, but larger studies are recommended.
Many pregnant persons in the United States are receiving coronavirus disease 2019 (Covid-19) vaccines, but data are limited on their safety in pregnancy. From December 14, 2020, to February 28, 2021, we used data from the “v-safe after vaccination health checker” surveillance system, the v-safe pregnancy registry, and the Vaccine Adverse Event Reporting System (VAERS) to characterize the initial safety of mRNA Covid-19 vaccines in pregnant persons.
RESULTS
A total of 35,691 v-safe participants 16 to 54 years of age identified as pregnant. Injection-site pain was reported more frequently among pregnant persons than among nonpregnant women, whereas headache, myalgia, chills, and fever were reported less frequently. Among 3958 participants enrolled in the v-safe pregnancy registry, 827 had a completed pregnancy, of which 115 (13.9%) resulted in a pregnancy loss and 712 (86.1%) resulted in a live birth (mostly among participants with vaccination in the third trimester). Adverse neonatal outcomes included preterm birth (in 9.4%) and small size for gestational age (in 3.2%); no neonatal deaths were reported. Although not directly comparable, calculated proportions of adverse pregnancy and neonatal outcomes in persons vaccinated against Covid-19 who had a completed pregnancy were similar to incidences reported in studies involving pregnant women that were conducted before the Covid-19 pandemic. Among 221 pregnancy-related adverse events reported to the VAERS, the most frequently reported event was spontaneous abortion (46 cases).
CONCLUSIONS
Preliminary findings did not show obvious safety signals among pregnant persons who received mRNA Covid-19 vaccines. However, more longitudinal follow-up, including follow-up of large numbers of women vaccinated earlier in pregnancy, is necessary to inform maternal, pregnancy, and infant outcomes.
MONITORING SYSTEMS AND COVERED POPULATIONS
V-safe Surveillance System and Pregnancy Registry
V-safe is a new CDC smartphone-based active-surveillance system developed for the Covid-19 vaccination program; enrollment is voluntary. V-safe sends text messages to participants with weblinks to online surveys that assess for adverse reactions and health status during a postvaccination follow-up period. Follow-up continues 12 months after the final dose of a Covid-19 vaccine. During the first week after vaccination with any dose of a Covid-19 vaccine, participants are prompted to report local and systemic signs and symptoms during daily surveys and rank them as mild, moderate, or severe; surveys at all time points assess for events of adverse health effects. If participants indicate that they required medical care at any time point, they are asked to complete a report to the VAERS through active telephone outreach.
To identify persons who received one or both Covid-19 vaccine doses while pregnant or who became pregnant after Covid-19 vaccination, v-safe surveys include pregnancy questions for persons who do not report their sex as male. Persons who identify as pregnant are then contacted by telephone and, if they meet inclusion criteria, are offered enrollment in the v-safe pregnancy registry. Eligible persons are those who received vaccination during pregnancy or in the periconception period (30 days before the last menstrual period through 14 days after) and are 18 years of age or older. For persons who choose to enroll, the pregnancy registry telephone-based survey collects detailed information about the participant, including medical and obstetric history, pregnancy complications, birth outcomes, and contact information for obstetric and pediatric health care providers to obtain medical records; infants are followed through the first 3 months of life. Details about v-safe and v-safe pregnancy registry methods have been published previously.10,11
OUTCOMES
V-safe outcomes included participant-reported local and systemic reactogenicity to the BNT162b2 (Pfizer–BioNTech) vaccine and the mRNA-1273 (Moderna) vaccine on the day after vaccination among all pregnant persons 16 to 54 years of age and among nonpregnant women 16 to 54 years of age as a comparator. For analysis of pregnancy outcomes in the v-safe pregnancy registry, data were restricted to completed pregnancies (i.e., live-born infant, spontaneous abortion, induced abortion, or stillbirth). Participant-reported pregnancy outcomes included pregnancy loss (spontaneous abortion and stillbirth) and neonatal outcomes (preterm birth, congenital anomalies, small size for gestational age, and neonatal death) (Table S1 in the Supplementary Appendix, available with the full text of this article at NEJM.org). In the VAERS, outcomes included non–pregnancy-specific adverse events and pregnancy- and neonatal-specific adverse events.
STATISTICAL ANALYSIS
Demographic information and pregnancy characteristics are described for both v-safe and VAERS participants. Descriptive analyses were performed with the use of v-safe survey data for persons who identified as pregnant through February 28, 2021 (35,691 persons); persons enrolled in the v-safe pregnancy registry who were vaccinated through February 28, 2021 (3958 persons); and VAERS reports involving pregnant women received through February 28, 2021 (221 persons). Local and systemic reactogenicity was compared between persons who identified as pregnant and nonpregnant women. Descriptive analyses were conducted with the use of SAS software, version 9.4 (SAS Institute). All activities were reviewed by the CDC and were conducted in accordance with applicable federal law and CDC policy.
The vaccine uses tried and true science with a proven track record of safety It uses the same technology as the popular Flublok influenza vaccine and the hepatitis B vaccine, which have been used safely by huge numbers of people for numerous years.
It uses the same technology as the popular Flublok influenza vaccine and the hepatitis B vaccine, which have been used safely by huge numbers of people for numerous years.
Some people have claimed that the Novavax vaccine used a new type of technology that hasn’t been proven safe based on past use. This is false. MedPage Today explains:
Novavax’s COVID-19 vaccine candidate could be the first authorized or approved in the U.S. to rely on a “tried and true” method for immunizing people against coronavirus.
This purified protein, or protein subunit, vaccine strategy is used in many other vaccines on the market today — so does it have a role to play in easing hesitancy to COVID vaccines?
Experts in public health, infectious diseases, and vaccinology interviewed by MedPage Today said that while there are some notable caveats, it’s certainly possible that having the option could help, and that they’d welcome anything that would get more people rolling up their sleeves.
For Novavax’s protein subunit vaccine candidate (known as NVX-CoV2373), spike protein is made by infecting cultures of insect (Spodoptera frugiperda) cells with a baculovirus that’s been altered to contain genes for making the spike. The cells then churn out spike proteins, which are purified and mixed with an adjuvant to make the vaccine.
The Novavax candidate contains the “Matrix-M” adjuvant, which is composed of the plant-derived glycoside saponin, cholesterol, and phospholipids.
Paul Offit, MD, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said this is the exact same technology used in the Flublok influenza vaccine, and is similar to other purified protein vaccines that have been around for a long time, like the hepatitis B vaccine.
Other COVID-19 vaccines using more traditional technology are in development or in use in other countries, though it’s not clear they’ll become available in the U.S.
William Schaffner, MD, an infectious disease expert at Vanderbilt University Medical Center in Nashville, said there could be an advantage in the emotional appeal of a vaccine strategy with an apparent track record.
“Psychologists tell us that facts are essential, but what changes behavior is how people feel about something,” Schaffner told MedPage Today. “They have to feel comfortable and reassured. … Anything that will persuade some people to make them feel more comfortable in accepting a vaccine is something I endorse.”
The spike proteins from Covid vaccines are safe Spike proteins have been used in many vaccines. They mimic a small part of the virus to train the immune system to recognize and beat the virus.
Spike proteins have been used in many vaccines. They mimic a small part of the virus to train the immune system to recognize and beat the virus.
As reported by First Draft News, here is one falsehood being spread:
Some anti-vaccine conspiracy theorists responded to the Novavax US phase 3 trial data by repeating the false narrativethat spike proteins — the mechanism by which the Novavax and other vaccines produce an immune response — are harmful. “Novavax injection just dumps millions of spike proteins right into your body. Can’t wait to see all the myocarditis from that,” reads a tweet from Dr. Jane Ruby, who describes herself as a medical expert and who recently amplified the false claim that Covid-19 vaccines induce magnetism.
To see the whole article, click here. Here’s a clip from Politifact that rebuts this falsehood:
There’s no evidence to support the claim that spike protein is dangerous. The spike proteins produced as a result of vaccination help stimulate the body’s defenses against COVID-19. The U.S. Centers for Disease Control and Prevention calls them “harmless.”
Ruby, whose Twitter account identifies her as “Dr. Jane Ruby,” is not a medical doctor. She describes herself as a health economist and “New Right political pundit” with a doctorate in psychology. Her LinkedIn profile shows he has a background in pharmaceutical research and nursing.
We messaged Ruby via Twitter but didn’t get a reply.
We have fact-checked other spike protein claims, finding that there is no evidence they present any serious health risk on their own.
We rated False a claim by Canadian viral immunologist Byram Bridle that the COVID-19 vaccines’ spike protein means people are being inoculated “with a toxin.” Experts said there is no evidence that the vaccines produce a toxin that could cause heart problems and neurological damage, as Bridle alleged.
We also rated False a claim that COVID-19 vaccines’ “spike protein is very dangerous, it’s cytotoxic,” which means toxic to cells. U.S. public health authorities and vaccine experts said there is no evidence that the vaccines’ spike protein is toxic or “cytotoxic.”
“This protein has not been shown to be dangerous,” he said. “It’s just a single viral protein similar to the hepatitis B and human papillomavirus vaccines, and are remarkably safe.”
“The SARS-CoV-2 virus, on the other hand, reproduces itself thousands of times, and is incredibly dangerous.”
The National Institutes of Health said data from the trial “indicate the investigational vaccine was generally well-tolerated.” The most common side effects were mild to moderate pain at the injection site, fatigue, headache and temporary muscle pain. We rate the post False.
To read the full article, go here.