(Reuters) - The U.S. Department of Health and Human Services (HHS) said on Thursday it will provide up to $500 million for mid-stage trials evaluating vaccines administered as a nasal spray or pill to protect against symptomatic COVID-19.
The funding is part of Project NextGen, a $5 billion initiative led by the Biomedical Advanced Research and Development Authority (BARDA), to advance a pipeline of new, innovative vaccines and therapeutics providing broader and more durable protection against COVID-19 infection.
BARDA, which helps companies develop medical supplies to address public health threats, is a part of HHS.
The project is awarding up to $453 million to Vaxart for a study that will evaluate its oral COVID vaccine. The company's shares more than doubled to $1.78 after market.
It is also awarding privately held Castlevax and Cyanvac around $34 million and $40 million, respectively, to develop their intranasal vaccine candidates.
Each trial will enroll 10,000 volunteers and compare the efficacy and safety of the investigational vaccines to FDA-licensed vaccines.
"Currently approved COVID-19 vaccines are administered intramuscularly and, while extremely effective, are limited in their capacity to induce a robust immune response in mucosal areas such as the mouth, nose and gut, where the SARS-CoV-2 virus first enters the body," the HHS said.
(Reporting by Puyaan Singh in Bengaluru; Editing by Shounak Dasgupta)
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Patients who received one or more COVID-19 vaccine doses after acute coronary syndrome (ACS) had similar rates of all-cause death, heart attack, stroke, urgent coronary revascularization, major cardiovascular events, and hospitalization for chest pain, heart failure, and respiratory infections as their unvaccinated peers, according to a secondaryanalysis of a randomized clinical trial.
The research was published inJAMA Network Open.
An international team led by researchers from Hospital Israelita Albert Einstein in Sao Paulo, Brazil, analyzed results from the Vaccination Against Influenza to Prevent Cardiovascular Events After Acute Coronary Syndromes trial.
The trial evaluated the effectiveness of the influenza vaccine post-ACS from July 2019 to November 2020, while the secondary analysis compared the rate of cardiopulmonary events in patients who received at least one dose of COVID-19 vaccine in Brazil with that of unvaccinated participants. Patients were not randomized to the COVID vaccine in the secondary analysis.
In this secondary analysis of a randomized clinical trial, patients who received at least 1 COVID-19 vaccine dose after ACS had similar rates of the primary composite end point and MACE compared with unvaccinated patients.
Of 1,801 patients (median age, 56.7 years; 30.3% women), 16.2% had a history of heart attack, and 35.7% smoked. In total, 1,665 patients did not have cardiopulmonary events in the first 90 days, of whom 50.2% had received at least one COVID-19 vaccine dose. Most (63.9%) received at least one Oxford/AstraZeneca dose during follow-up.
In the 90-day event-free follow-up analysis of unvaccinated individuals, the rate of all-cause death, heart attack, stroke, urgent coronary revascularization, major cardiovascular events, and hospitalization for chest pain, heart failure, and respiratory infections per 100 patient-years was 9.37, versus 4.81 for vaccinated patients (adjusted hazard ratio [aHR], 0.41).
Vaccination didn't significantly lower the rate ofMACE (aHR, 0.32), all-cause death (aHR, 0.29), or cardiovascular death (aHR, 0.42).
"In this secondary analysis of a randomized clinical trial, patients who received at least 1 COVID-19 vaccine dose after ACS had similar rates of the primary composite end point and MACE compared with unvaccinated patients," the researchers wrote. "However, retrospective studies have demonstrated a short-term reduction in MACE risk after COVID-19 vaccination."
Award will support a 10,000-participant study comparing CyanVacs PIV5-based intranasal vaccine candidate CVXGA with a commercial COVID-19 vaccine under BARDAs Clinical Studies Network
ATHENS, Ga. & SAN JOSE, Calif., June 13, 2024--(BUSINESS WIRE)--CyanVac LLC, a clinical-stage biotechnology company developing intranasal vaccines using a transformational parainfluenza virus 5 (PIV5)-based vector, announced today that it received federal Project NextGen funding to support a comparative Phase 2b study of CVXGA, the companys PIV5-based vaccine candidate designed to protect against COVID-19.
Project NextGen is an initiative of the U.S. Department of Health and Human Services (HHS) to advance new, innovative vaccines and therapeutics providing broader and more durable protection for COVID-19. The award is one of the first made through the Rapid Response Partnership Vehicle, a consortium funded by the Biomedical Advanced Research and Development Authority (BARDA) part of the Administration for Strategic Preparedness and Response (ASPR) within HHS, to accelerate product and technology development.
The Phase 2b study of PIV-5-based CVXGA intranasal COVID-19 vaccine will be conducted through BARDAs clinical studies network.
"This award will accelerate the development of our PIV5-based intranasal COVID-19 vaccine, building on our very promising Phase 1 and preliminary Phase 2a clinical trial results," said Biao He, Ph.D., founder and CEO of CyanVac. "PIV5 is a novel intranasal vaccine vector that has been shown to replicate safely in humans in clinical trials and stimulates all three pillars of immunity cellular, mucosal, and humoral with minimal uncomfortable side effects. The successful development of an intranasal COVID-19 vaccine using this new vector will demonstrate the capabilities of our PIV5 platform and benefit the development of PIV5-based vaccines for other emerging infectious diseases."
Under the award, CyanVac will be the sponsor for a 10,000 participant, randomized double-blinded Phase 2b study that will compare the efficacy, safety and immunogenicity of CyanVacs next-generation intranasal COVID-19 vaccine candidate to a U.S. Food and Drug Administration (FDA)-approved mRNA-based COVID-19 vaccine. The study will be conducted through BARDA's Clinical Studies Network and will evaluate the vaccine in a subset of participants at higher risk of severe disease. The study is expected to start in the fall of 2024 and will evaluate the efficacy of CVXGA in preventing not only severe COVID-19 infections, but also asymptomatic infections.
Story continues
"Many vaccines including COVID-19 vaccines are quite effective at preventing serious illness and death, but there is a need for vaccines that can also block transmission of a pathogen to other people," said Dr. Henry Radziewicz, Chief Medical Officer of CyanVac. "Our intranasal vaccine is delivered to mucosal surfaces, a key focus area for Project NextGen by BARDA because such vaccines have the potential to reduce the spread of disease."
"We are excited to work with BARDA on this large-scale trial and are grateful for their support," added Dr. He.
The project is being funded with federal funds from HHS, ASPR, BARDA, under Other Transaction (OT) number 75A50123D00005.
About CVXGA
CVXGA is a clinical-stage COVID-19 vaccine candidate based on a proprietary parainfluenza virus 5 (PIV5) vector that encodes the spike (S) protein of SARS-CoV-2. The PIV5 vector was developed at the University of Georgia and is based on a respiratory virus that is not known to cause disease in humans which has been commonly administered to dogs as part of combination distemper/kennel cough vaccines for decades. CyanVac and its affiliate, Blue Lake Biotechnology, are developing CVXGA as a single-dose, intranasal vaccine to prevent SARS-CoV-2 infection and serious complications associated with COVID-19. Preclinical studies have demonstrated that CVXGA is immunogenic and protective and prevents transmission of SARS-CoV-2. Phase 1 data has shown that subjects dosed with CVXGA showed robust mucosal, cellular and humoral immune responses with limited or no reactogenicity and no serious events assessed as related to the vaccine.
About CyanVac and Blue Lake Biotechnology
CyanVac LLC and its affiliate, Blue Lake Biotechnology, Inc., are developing intranasal vaccines that harness the full breadth of the immune system to keep people healthy, prevent serious infectious diseases, and protect the health of vulnerable populations. Our platform uses a proprietary parainfluenza virus 5 vector into which a foreign gene from a targeted pathogen is inserted. We have generated a robust clinical-stage pipeline of best-in-class vaccines designed to overcome the limitations of existing vaccine technologies. Our lead product candidates have demonstrated potential for high efficacy and durability with few vaccine-related side effects.
Learn more at CyanVac and Blue Lake Biotechnology.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240613249656/en/
Contacts
Carolyn Hawley Inizio Evoke Comms carolyn.hawley@inizioevoke.com 619-849-5382
Samuel Wu, Chief Business Officer CyanVac LLC and Blue Lake Biotechnology, Inc. swu@cyanvacllc.com 650-609-2231
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A study yesterday in Emerging Infectious Diseases spotlights recent H1N1 flu cases with reduced susceptibility to oseltamivir (Tamiflu), the most common antiviral used to limit symptoms from seasonal flu.
The reduction in susceptibility has been seen in viruses collected from five continentswith most cases in Europefrom May 20203 to February 2024. The viruses showed a 13-fold reduced inhibition by oseltamivir while retaining normal susceptibility to other antiviral drugs, the authors said.
The detections were made as part of standard genetic sequencing of influenza viruses, and included 2,039 H1N1 viruses from the United States (1,274) and 38 other countries (765).
The viruses that lost susceptibility to Tamiflu had acquired a novel combination of neuraminidase mutations, NA-I223V + S247N. Overall detection frequency of these two mutations was low (0.67%). Of 101 viruses with this double mutation, 67 were found in Europe.
"The first dual mutant was collected from Canada in May 2023, and the latest were collected from 4 countries (France, the Netherlands, Spain, and the United Kingdom) during JanuaryFebruary 2024," the authors wrote.
The Netherlands had the most detections (30), followed by France (24), Bangladesh (11), Oman (9), and the United Kingdom (9). Hong Kong had 4 detections, followed by Niger (3), Australia (2), Spain (2), and the United States (2). One dual mutant each was detected in Canada, Ethiopia, Maldives, Norway, and Sweden.
Our study highlights the need to closely monitor evolution of dual mutants .
"Our study highlights the need to closely monitor evolution of dual mutants because additional changes may further affect susceptibility to antiviral drugs or provide a competitive advantage over circulating wild-type viruses," the authors concluded.
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Patients who received one or more COVID-19 vaccine doses after acute coronary syndrome (ACS) had similar rates of all-cause death, heart attack, stroke, urgent coronary revascularization, major cardiovascular events, and hospitalization for chest pain, heart failure, and respiratory infections as their unvaccinated peers, according to a secondaryanalysis of a randomized clinical trial.
The research was published inJAMA Network Open.
An international team led by researchers from Hospital Israelita Albert Einstein in Sao Paulo, Brazil, analyzed results from the Vaccination Against Influenza to Prevent Cardiovascular Events After Acute Coronary Syndromes trial.
The trial evaluated the effectiveness of the influenza vaccine post-ACS from July 2019 to November 2020, while the secondary analysis compared the rate of cardiopulmonary events in patients who received at least one dose of COVID-19 vaccine in Brazil with that of unvaccinated participants. Patients were not randomized to the COVID vaccine in the secondary analysis.
In this secondary analysis of a randomized clinical trial, patients who received at least 1 COVID-19 vaccine dose after ACS had similar rates of the primary composite end point and MACE compared with unvaccinated patients.
Of 1,801 patients (median age, 56.7 years; 30.3% women), 16.2% had a history of heart attack, and 35.7% smoked. In total, 1,665 patients did not have cardiopulmonary events in the first 90 days, of whom 50.2% had received at least one COVID-19 vaccine dose. Most (63.9%) received at least one Oxford/AstraZeneca dose during follow-up.
In the 90-day event-free follow-up analysis of unvaccinated individuals, the rate of all-cause death, heart attack, stroke, urgent coronary revascularization, major cardiovascular events, and hospitalization for chest pain, heart failure, and respiratory infections per 100 patient-years was 9.37, versus 4.81 for vaccinated patients (adjusted hazard ratio [aHR], 0.41).
Vaccination didn't significantly lower the rate ofMACE (aHR, 0.32), all-cause death (aHR, 0.29), or cardiovascular death (aHR, 0.42).
"In this secondary analysis of a randomized clinical trial, patients who received at least 1 COVID-19 vaccine dose after ACS had similar rates of the primary composite end point and MACE compared with unvaccinated patients," the researchers wrote. "However, retrospective studies have demonstrated a short-term reduction in MACE risk after COVID-19 vaccination."
10,000-subject Phase 2b study will evaluate Vaxarts next generation oral pill COVID-19 vaccine against an approved mRNA vaccine comparator
Vaxart anticipates initiating enrollment as early as summer 2024
SOUTH SAN FRANCISCO, Calif., June 13, 2024 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) announced today that it received a project award valued at up to $453 million through the Rapid Response Partnership Vehicle (RRPV). The RRPV is a Consortium funded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS).
The funds will be used to conduct a Phase 2b comparative study evaluating Vaxarts oral pill COVID-19 vaccine candidate against a U.S. Food and Drug Administration (FDA)-approved mRNA vaccine comparator. In preparation for the trial, Vaxart created and manufactured under Good Manufacturing Practice (GMP) standards a next-generation oral COVID-19 vaccine tablet candidate that based on preclinical data is more potent than Vaxarts prior COVID-19 vaccine constructs.
Funding under the award will be provided in two parts with approximately $65.7 million available immediately to continue study start-up activities, and the remainder of approximately $387.2 million provided when Vaxart and BARDA have determined that the study may further proceed and paid over the course of the study. Currently, Vaxart anticipates initiating enrollment as early as summer 2024. An interim analysis for vaccine efficacy compared to an approved mRNA comparator may occur as early as the first quarter of 2025.
We are grateful to BARDA for this funding, which will enable Vaxart to conduct a Phase 2b trial for our COVID-19 oral pill vaccine candidate. This trial will evaluate whether our oral pill vaccine candidate compares favorably against an approved mRNA injectable vaccine, said Dr. James F. Cummings, Vaxarts Chief Medical Officer. We are excited to explore the results of this head-to-head comparison. Previous research showed that our earlier COVID-19 vaccine constructs triggered long-lasting immune responses and induced a cross-reactive immunogenic response against all tested SARS-CoV-2 variants.
Vaccine delivery has relied primarily on injection for more than 150 years. This funding from BARDA will assist us in determining whether we can bring a transformational, next-generation approach to global vaccination, said Steven Lo, Vaxarts Chief Executive Officer. We believe our oral pill vaccine platform can better meet societal needs not just for COVID-19, which is now in the endemic phase, but for other infectious diseases that present significant endemic and pandemic threats.
Vaxart was the first U.S. company to complete a Phase 2 clinical trial of an oral vaccine for COVID-19. In earlier clinical trials, Vaxart demonstrated its COVID-19 vaccine candidates generated robust cross-reactive mucosal IgA responses, boosted immune responses to existing COVID-19 vaccines, increased neutralizing antibodies against Omicron 4/5, and had a benign tolerability profile.
Funding for this award was received under Project NextGen, a $5 billion initiative by HHS to develop new, innovative vaccines and therapeutics that provide broader and more durable protection against COVID-19 than the first generation COVID-19 vaccines and medicines. This project has been funded with federal funds from HHS; ASPR; BARDA, under Other Transaction (OT) number 75A50123D00005.
About the COVID-19 Phase 2b Trial
The Phase 2b trial is a double-blind, multi-center, randomized, comparator-controlled study to determine the relative efficacy, safety, and immunogenicity of Vaxarts oral pill COVID-19 vaccine candidate against an approved mRNA COVID-19 injectable vaccine in adults previously immunized against COVID-19 infection. The study design anticipates enrolling approximately 10,000 healthy adults 18 years and older in the United States with 5,000 receiving Vaxarts COVID-19 vaccine candidate and 5,000 receiving an approved mRNA comparator. At least 25% of the participants should be at least 65 years old.
The study will measure efficacy for symptomatic and asymptomatic disease, systemic and mucosal immune induction, and the incidence of adverse events. The primary endpoint is relative efficacy of Vaxarts COVID-19 vaccine candidate compared to an approved mRNA comparator for the prevention of symptomatic disease. Primary efficacy analysis will be performed when all participants have either discontinued or completed a study visit 12 months post-vaccination.
An independent Data and Safety Monitoring Board (DSMB) will review safety data of the participants.
Execution of this Phase 2b study will be funded by BARDA through the RRPV.
About Vaxart Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using pills that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart believes that its proprietary pill vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Vaxarts development programs currently include pill vaccines designed to protect against coronavirus, norovirus and influenza, as well as a therapeutic vaccine for human papillomavirus (HPV), Vaxarts first immune-oncology indication. Vaxart has filed broad domestic and international patent applications covering its proprietary technology and creations for oral vaccination using adenovirus and TLR3 agonists.
Note Regarding Forward-Looking Statements This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding Vaxart's strategy, prospects, plans and objectives, receipt of funding from BARDA for the Phase 2b study, results from preclinical and clinical trials and the timing of such trials and results, commercialization agreements and licenses, and beliefs and expectations of management are forward-looking statements. These forward-looking statements may be accompanied by such words as "should," "believe," "could," "potential," "will," "expected," anticipate, "plan," and other words and terms of similar meaning. Examples of such statements include, but are not limited to, statements relating to Vaxarts receipt of funding from BARDA for the Phase 2b study (or for any other purpose), Vaxart's ability to develop and commercialize its product candidates, including its vaccine booster products; Vaxart's expectations regarding clinical results and trial data, and the timing of receiving and reporting such clinical results and trial data; Vaxarts expectations regarding timing of enrollment in studies; and Vaxart's expectations with respect to the effectiveness of its product candidates. Vaxart may not actually achieve the plans, carry out the intentions, or meet the expectations or projections disclosed in the forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations, and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that Vaxart makes, including uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement, and/or completion dates for clinical trials, regulatory submission dates, regulatory approval dates, and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from the clinical studies; decisions by regulatory authorities impacting labeling, manufacturing processes, and safety that could affect the availability or commercial potential of any product candidate, including the possibility that Vaxart's product candidates may not be approved by the FDA or non-U.S. regulatory authorities; that, even if approved by the FDA or non-U.S. regulatory authorities, Vaxart's product candidates may not achieve broad market acceptance; that a Vaxart collaborator may not attain development and commercial milestones; that Vaxart or its partners may experience manufacturing issues and delays due to events within, or outside of, Vaxart's or its partners' control; difficulties in production, particularly in scaling up initial production, including difficulties with production costs and yields, quality control, including stability of the product candidate and quality assurance testing, shortages of qualified personnel or key raw materials, and compliance with strictly enforced federal, state, and foreign regulations; that Vaxart may not be able to obtain, maintain, and enforce necessary patent and other intellectual property protection; that Vaxart's capital resources may be inadequate; Vaxart's ability to resolve pending legal matters; Vaxart's ability to obtain sufficient capital to fund its operations on terms acceptable to Vaxart, if at all; the impact of government healthcare proposals and policies; competitive factors; and other risks described in the "Risk Factors" sections of Vaxart's Quarterly and Annual Reports filed with the SEC. Vaxart does not assume any obligation to update any forward-looking statements, except as required by law.
Contacts
Early in the COVID-19 pandemic, Black Americans were more hesitant to take the COVID vaccine than were White Americans. As the pandemic went on, however, the disparity in vaccination rates between Black and White adults declined. In a paper titled What Caused the Narrowing of Black-White COVID-19 Vaccination Disparity in the US? A Test of 5 Hypotheses, published in the current issue of the Journal of Health Communication, researchers at the Annenberg Public Policy Center (APPC) assessed explanations for the positive change.
Using April 2021 to July 2022 data from the Annenberg Science and Public Health (ASAPH) survey, a national panel of over 1,800 U.S. adults, a team led by APPC research director Dan Romer assessed potential explanations, including: increased trust in the Centers for Disease Control and Prevention (CDC), exposure to pro-vaccination messages in the media, awareness of COVID-inflicted deaths among personal contacts, and improved access to vaccines. None of these factors explained the decline in disparity, however. Only increased knowledge about COVID-19 vaccination made a difference. Knowledge about the COVID vaccine among Black Americans increased over time, and this increase was associated with their receipt of the vaccine.
Black Americans became less skeptical of the safety and efficacy of the vaccine as time proceeded, which appeared in our data to be an important contributor to increased vaccination rates among them, says Romer.
In the initial wave of the survey, in April 2021, Black respondents were more likely to believe various forms of misinformation about COVID vaccines, such as that the vaccines are responsible for thousands of deaths and that the vaccines can change someones DNA. By the end of the survey period, knowledge about the vaccine among Black Americans had increased significantly.
Read more at Annenberg Public Policy Center.
As new variants of the coronavirus continue to gain traction, doctors and researchers are bracing for a potential rise in cases this summer. Heres what to know about symptoms, testing and treatment if you fall ill.
WATCH OUT FOR THE USUAL SYMPTOMS.
Theres no evidence that symptoms of the new dominant COVID variants, KP.3 and KP.2, which account for nearly half of all cases, are any different from other recent strains of the virus, said Aubree Gordon, an infectious disease epidemiologist at the University of Michigan. The symptoms include sneezing, congestion, headaches, sore muscles, nausea or vomiting. Many people also report exhaustion and a blah feeling.
In general, the more immunity youve built up from vaccination or past infections, the milder your next bout with the virus is likely to be. (Though its possible to experience more intense symptoms.)
GET TESTED.
In an ideal world, experts said, people would take a COVID test as soon as they develop symptoms or learn they were exposed, and then test again a day or two later.
If you have other symptoms but few at-home rapid tests on hand, you may want to wait a few days to test, to reduce the chance of a false negative. If youve had symptoms for more than three days but are still testing negative, its unlikely youll ever test positive on an at-home test, Dr. Gordon said either because you do not have COVID, or because you are shedding amounts of the virus that are too low for a rapid test to pick up.
CONSIDER MEDICATIONS TO PREVENT AND TREAT COVID.
People age 12 and older who have tested positive can take Paxlovid within five days of developing symptoms. The medication halts the virus from replicating in the body and lowers the risk of death for people who are more vulnerable to severe disease. There is no evidence that Paxlovid is less effective against the current leading variants than previous strains of the virus, experts said. Scientists are still debating whether Paxlovid can reduce the risk of developing long COVID.
Doctors advise resting as much as possible while sick. Some people like to take long walks, said Dr. Davey Smith, an infectious disease specialist at the University of California, San Diego. I just stay in bed and read a book. Basically, you just suffer through it.
This article originally appeared in The New York Times.
FDA, DOJ Scrutinized Over Inaction on Youth Vaping Crisis
In a rare bipartisan effort, the Senate Judiciary Committee grilled the FDA and the Department of Justice for their perceived inaction on the youth vaping crisis amid the surge in flavored e-cigarette sales, according to CNN. Despite a court mandate to regulate e-cigarette products by September 2021, the FDA has struggled to keep pace with the influx of applications, authorizing only 23 products so far. Senators emphasized the urgent need for decisive action to remove illegal, youth-targeted flavored vapes from the market and criticized the FDA for not leveraging its enforcement capabilities more effectively.
Moderna's Next-Generation COVID-19 Vaccine Outperforms Current Shot in Efficacy
Moderna's latest COVID-19 vaccine demonstrated superior efficacy in a late-stage trial involving over 11,000 participants aged 12 years and older, outperforming the existing Spikevax shot, particularly in adults, according to Reuters. Designed for enhanced stability, the new vaccine can be stored in refrigerators, addressing distribution challenges in developing countries. The company is also exploring a combination vaccine for COVID-19 and flu, aiming for a potential market launch as early as the next autumn respiratory season.
Supreme Court Upholds Access to Key Abortion Drug
The US Supreme Court rejected a lawsuit challenging the FDAs approach to regulating the abortion pill mifepristone, according to CNN. The decision will allow the pills to be mailed to patients without an in-person doctors visit. The ruling is considered a significant victory for abortion rights advocates amidst ongoing national debates and legal battles over reproductive rights.
In a recent study published in the journal Obstetrics & Gynecology, researchers evaluate the association between antenatal coronavirus disease 2019 (COVID-19) vaccination and adverse pregnancy outcomes.
Study:Obstetric complications and birth outcomes after antenatal coronavirus disease 2019 (COVID-19) vaccination. Image Credit: Anuta23 / Shutterstock.com
Most individuals infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the pathogen responsible for COVID-19, experience mild symptoms or remain asymptomatic throughout the infection. However, certain patient populations, such as older adults, those with certain comorbidities, and pregnant women, are at an increased overall risk of mortality and morbidity when infected with SARS-CoV-2. In pregnant women, COVID-19 increases the risk of cesarean delivery, hypertensive disorders of pregnancy (HDP), and preterm birth (PTB).
Despite being excluded from the initial clinical trials on COVID-19 vaccines, pregnant women were advised to be vaccinated against COVID-19. Soon after their approval and subsequent distribution to the public, messenger ribonucleic acid (mRNA) COVID-19 vaccines were found to significantly reduce the risk of COVID-19-related complications in both pregnant women and their infants during the first six months of life. Nevertheless, there remains a lack of data on how antenatal COVID-19 vaccination affects the risk of adverse pregnancy outcomes. To this end, the current study aimed to elucidate the association between antenatal vaccination and the risk of small-for-gestational-age (SGA) infants, PTB, gestational diabetes mellitus (GDM), and HDP including gestational hypertension, preeclampsia-eclampsia, and hemolysis, elevated liver enzymes, and low platelet count (HELLP) syndrome.
The current retrospective study included women who delivered live singleton babies between June 1, 2021, and January 31, 2022. Data were obtained from eight healthcare systems that were part of the Vaccine Safety Datalink (VSD), which links healthcare organizations to monitor vaccine safety in the United States.
Patients were categorized based on their vaccine history. This included controls and patients who received one or more doses of either the Pfizer-BioNTech or Moderna mRNA COVID-19 vaccines during pregnancy who were placed in the vaccine exposure cohort.
The study included 55,691 women, 42.3% of whom received one or two primary series of the mRNA COVID-19 vaccine doses during pregnancy. Study participants were more likely to be vaccinated if they were older, as they had a mean age of 31.7 years as compared to non-vaccinated study participants with a mean age of 29.6 years. Moreover, vaccinated women were more likely to be non-Hispanic Asian and less likely to be Hispanic or non-Hispanic Black. Neighborhood poverty was also lower among vaccinated study participants.
Women who received the vaccine during pregnancy had a lower risk of 6.4% of PTB before 37 weeks of gestation compared to 7.7% among unvaccinated women. However, receipt of an mRNA COVID-19 vaccine did not appear to impact the risk of PTB when vaccine exposure by pregnancy trimester was considered. COVID-19 vaccination did not increase or decrease the risk of SGA infants, GDM, HDP, including HELLP syndrome, or gestational hypertension.
Previous studies have shown that the risk of adverse outcomes for both mothers and infants due to moderate to severe COVID-19 is significantly less after one or two antenatal doses of an mRNA vaccine. Likewise, the current study reported that the risk of severe COVID-19 was reduced by 74% and 90% after one and two vaccine doses, respectively.
Receipt of an mRNA COVID-19 vaccine during pregnancy was not associated with an increased risk of adverse pregnancy outcomes.
Some notable strengths of the current study include the large cohort of individuals with diverse racial, ethnic, and geographic backgrounds, thorough analysis of obstetric complications and birth outcomes, as well as the inclusion of first trimester COVID-19 vaccination records.
Importantly, some limitations of this study include the lack of data on COVID-19 diagnoses that did not require medical attention and the inclusion of vaccinated individuals before becoming pregnant. Furthermore, only women with live births who had health insurance were included in the study, which may limit the generalizability of the findings.
Taken together, the study findings validate previous reports confirming the safety of mRNA COVID-19 vaccination during pregnancy.
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