Category: Corona Virus Vaccine

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.

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What We're Reading: Youth Vaping Crisis; New COVID-19 Vaccine Superior to Current Shot; Supreme Court Upholds ... - AJMC.com Managed Markets Network

PROVIDENCE Confirmed cases of COVID-19 in Rhode Island increased by 140, with one death, from June 2-8, theR.I. Department of Healthsaid Thursday. Typically, the state reports COVID-19 statistics collected from Sunday through Saturday of the previous week. New hospital admissions of COVID-19 patients totaled 18, up from seven reported May 26-June 1. By comparison,

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R.I. weekly COVID-19 cases increase by 140, with 1 death - Providence Business News

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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Antenatal COVID-19 vaccination shown to be safe for pregnant women and their babies - News-Medical.Net

L.L. Bean has just added a third shift at its factory in Brunswick, Maine, in an attempt to keep up with demand for its iconic boot.

Orders have quadrupled in the past few years as the boots have become more popular among a younger, more urban crowd.

The company says it saw the trend coming and tried to prepare, but orders outpaced projections. They expect to sell 450,000 pairs of boots in 2014.

People hoping to have the boots in time for Christmas are likely going to be disappointed. The bootsare back ordered through February and even March.

"I've been told it's a good problem to have but I"m disappointed that customers not getting what they want as quickly as they want," said Senior Manufacturing Manager Royce Haines.

Customers like, Mary Clifford, tried to order boots on line, but they were back ordered until January.

"I was very surprised this is what they are known for and at Christmas time you can't get them when you need them," said Clifford.

People who do have boots are trying to capitalize on the shortage and are selling them on Ebay at a much higher cost.

L.L. Bean says it has hired dozens of new boot makers, but it takes up to six months to train someone to make a boot.

The company has also spent a million dollars on new equipment to try and keep pace with demand.

Some customers are having luck at the retail stores. They have a separate inventory, and while sizes are limited, those stores have boots on the shelves.

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Summer surge? South Bay health officials keep close eye on COVID-19 concentrations - NBC Bay Area

Modernas combined coronavirus-influenza shot produced a higher immune response in older adults than separate vaccines for those viruses administered together, according to data the company released Monday.

The promising results from clinical trials, which have yet to be peer reviewed and published in a medical journal, could offer a new option to boost paltry uptake of updated coronavirus vaccines.

Moderna officials say the earliest that the combined vaccine could hit the market is fall 2025, pending regulatory approval.

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What to know about Moderna's combined covid-flu vaccine on the horizon - The Washington Post

Even though Los Angeles Unified dropped its COVID vaccine mandate for school staff almost a year ago, a lawsuit accusing the district of violating workers rights can still move forward, the U.S. 9th Circuit Court of Appeals ruled on Friday.

The 2-1 ruling by a pair of federal judges appointed by former President Donald Trump revives a case that a lower court had dismissed. It also counters recent rulings by courts including the 9th Circuit that tossed lawsuits challenging expired COVID-19 rules on the grounds that the policies were no longer in effect.

The judges in the majority wrote that this case was different because they found L.A. Unified demonstrated a pattern of withdrawing and reinstating its vaccination policies over the course of the lawsuit.

Accordingly, LAUSD has not carried its heavy burden to show that there is no reasonable possibility that it will again revert to imposing a similar policy, the opinion states.

They also indicated they were open to arguments over the effectiveness of the vaccine, which the U.S. Centers for Disease Control and Prevention describes as a safe way tobuild immunity against COVID-19.

At this stage, we must accept Plaintiffs allegations that the vaccine does not prevent the spread of COVID-19 as true, Judge Ryan Nelson wrote. The opinion characterizes that aspect of the ruling as preliminary and something that would be argued at a lower court.

In a concurring opinion, Judge Daniel Collins invoked Supreme Court precedent that compulsory treatment for the health benefit of the person treated as opposed to compulsory treatment for the health benefit of others implicates the fundamental right to refuse medical treatment.

The plaintiffs alleged that the vaccines do not prevent someone from becoming infected with COVID-19 and characterized it as a treatment rather than a traditional vaccine.

They argued that by requiring employees to get the COVID shot, the school district was interfering with workers rights to refuse medical treatment.

No one with any credibility would tell you that the vaccine prevented COVID or stopped the spread, said John Howard, a San Diego attorney who argued the case on behalf of a handful of Los Angeles Unified employees and an Idaho-based group called the Health Freedom Defense Fund thats filed several other COVID vaccine lawsuits.

But when the hysteria was going on, thats exactly what pharmaceutical companies and others said, Howard said. It was false.

The CDC says: COVID-19 vaccines are effective at protecting people from getting seriously ill, being hospitalized, and dying.

A 2022 study published in the medical journal Lancet found COVID vaccines reduced symptoms in infected people, but did not necessarily slow transmission, although previous research indicated vaccines were effective in slowing the spread of early COVID variants. The Johns Hopkins University Coronavirus Resource Center states that COVID vaccines likely reduce the risk of virus transmission but probably not completely in everyone.

The school district can appeal the ruling to a larger panel of judges on the 9th Circuit, which covers nine states and has been considered the most liberal of the nations appellate circuits. If the new ruling stands, the lawsuit would return to the U.S. District Court for Central California in Los Angeles for further arguments.

We are reviewing the 9th Circuit ruling and assessing the districts options, a spokesperson for the district said late Friday.

Lindsay Wiley, a law professor at UCLA and director of the schools Health Law and Policy Program, said the judges finding against a government intervention is extremely rare.

Judges applying this test are supposed to be highly deferential to the governments rationale and scientific findings, Wiley said. Its also notable that the judges in the majority went out of their way to reach the merits of the plaintiffs claim.

Perhaps most importantly, she said, the judges in the majority said the century-old law that upholds vaccine requirements does not apply unless the vaccine is effective in protecting others, not just the vaccinated person. This analysis is surprising and, I think, misguided.

The ruling could have a chilling effect on government attempts to require vaccines in the future, Wiley said. Governments should be careful to build the evidence base for their vaccination requirements, which are increasingly challenged by well-financed anti-vaccination groups in court.

Courts recently have dismissed similar complaints because Californias COVID public health emergency expired a year ago, ending state measures such as mask mandates and lockdowns.

In 2022, a 9th Circuit panel of 11 judges ruled that a lawsuit against Gov. Gavin Newsom over COVID-related school closures couldnt move forward since schools had reopened and there was no longer a live controversy. Another ruling, last month in a California state appeals court, drew a similar conclusion in a lawsuit against Newsom over COVID safety guidelines.

In a dissenting opinion to the L.A. case, 9th Circuit Judge Michael Hawkins extensively cited the 2022 ruling on California school closures. He was appointed to the court by former President Bill Clinton.

This case is over, he wrote. We cannot grant the sole relief sought by the Plaintiffs, an injunction against enforcement of the school districts now rescinded COVID-19 vaccination policy.

The lawsuit against L.A. Unified stems from the districts initial policy from March 2021 requiring all employees to show proof of having the COVID vaccine or risk losing their jobs. A group of employees sued, and the district tweaked the policy to allow employees to show a negative COVID test if they didnt want to get the vaccine.

A judge dismissed that suit, but, in August 2021, the district re-instated the vaccine mandate as schools re-opened for in-person instruction. The employees filed another suit, this time with the Health Freedom Defense Fund.

L.A. Unified, the nations second largest school district with more than 600,000 students, closed for in-person instruction for more than a year during the pandemic, like most school districts in California. Los Angeles was hit hard by the disease. As of last week, nearly 36,000 people in L.A. County have died of COVID, one of the highest per-capita mortality rates in California and far above the national average, according to public health data.

In August 2021, the United Teachers of Los Angeles union voted to support the districts vaccine mandate. Still, some district employees lost their jobs due to the districts mandate, Howard said.

People lost their homes, their careers. Some people had to leave the state. They had literally gone broke because of what L.A. Unified did to them, he said. It was appalling.

What questions do you have about Southern California?

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Vaccine Mandate Lawsuit - Los Angeles - LAist

Image source, Getty Images

10 June 2024

Drug company Moderna says its combined flu and Covid vaccine, which targets the two diseases in a single shot, has passed a vital part of final-stage scientific checks.

The phase-three trial shows the vaccine arms the body with protective antibodies.

And it does so as effectively as separate flu and Covid shots, results suggest.

Fewer injections would be more convenient and simpler, Moderna says.

Chief executive Stephane Bancel told BBC News he hoped the messenger ribonucleic acid (mRNA) vaccine could be made widely available in 2026 - or perhaps, 2025.

"We are very delighted about the results, because its the first time in the world that a company is able to show positive phase-three results combining in a single dose flu and Covid vaccine," he said.

"You get one dose, one needle," which meant "ease and peace of mind for the consumer".

Competitors Pfizer and BioNTech are testing a similar two-in-one mRNA vaccine against flu and Covid.

In the continuing Moderna trial, the mRNA-1083 jab produced a higher immune response than the licensed comparator vaccines.

It matched or bettered currently approved flu jabs, including high-dose ones designed for older people.

And it was better than Modernas existing Covid booster, Spikevax, at making the body produce disease-fighting antibodies probably because it had been designed to fight more recent variants circulating around the world, Mr Bancel told BBC News in an interview.

The results are from 8,000 volunteers all aged over 50 and half over 64.

Moderna said it had focused on older people because they were most likely to continue to be offered Covid vaccines.

But it plans ultimately to offer the new jab to younger people also.

Any side effects were generally mild - a bit of soreness where the needle went into the skin and some tiredness - as with regular vaccines.

The company plans to present the findings at a medical conference, as well as submit them for publication.

Prof John Tregoning, an immunologist at Imperial College London, said work on a dual vaccine was "a promising direction of travel", but that the science world awaited the full data for scrutiny.

Moderna is also developing an mRNA vaccine against a disease called cytomegalovirus, for which it hopes to have late-stage trial results this autumn.

Currently, there is nothing to protect pregnant women and their unborn babies against CMV.

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Moderna's two-in-one flu and Covid vaccine passes advanced trial - BBC

School holidays are coming up which means some of us may be heading on an interstate trip, a European holiday, or a visit to popular destination Bali.

And you may be wondering whether a COVID-19 booster is necessary as an extra layer of defence.

Although it's not mandatory, experts say travellers should stay up-to-date on COVID-19 boosters given their higher likelihood of exposure to the virus.

Here's how long it takes for a booster to reach maximum protection and who's eligible for one.

Associate professor of public health at the University of Technology Sydney Jane Frawley says you should get a booster two weeks before your holiday.

"The vaccine takes up to 14 days to be effective," Dr Frawley tells the ABC.

"Having a booster will drastically reduce the likelihood of getting COVID-19, and if you do get the virus, your symptoms will be mild in most cases."

Because travel is a high-risk behaviour.

"For some people, they might not perceive themselves to be at high enough risk to receive a booster," University of Queensland infectious disease physician Paul Griffin tells the ABC.

"But we do want people to appreciate the risk of travel and the impact of getting sick when you're trying to enjoy your time elsewhere."

Dr Frawley says you have to remember travelling often involves crowded environments and poor ventilation think airports, planes, cruise ships, trains, buses, and hotels.

This is where exposure is at its greatest.

That's hard to determine.

"It depends on how frequently you've been vaccinated, how long ago your last vaccine was, your own immune system, among some other factors," Dr Griffin says.

"The other thing that affects the performance of the vaccine is when the virus changes it can be hard to know exactly how long protection lasts.

"But what we do know is that while protection declines over time, that doesn't mean it disappears to zero quickly."

This is why the Australian Technical Advisory Group on Immunisation (ATAGI) says most adults (who are not severely immunocompromised) can consider getting a booster every 12 months.

That depends on your age and whether you're at higher risk of severe COVID-19.

Here are the booster dose recommendations according to the Department of Health:

You can also check your eligibility via the COVID-19 booster tool.

But as always, the best advice is to chat with your GP about your vaccine options.

In Australia, we only have one type of vaccine mRNA and there are two different manufacturers:

Dr Griffin says those in need of a booster should be getting the monovalent XBB 1.5 vaccine, which uses mRNA.

"Over the course of the pandemic, we've had multiple vaccines that targeted different variant/s: the original Wuhan strain, bivalent, and monovalent.

"But right now all we have available since the end of last year is the monovalent XBB 1.5 vaccine which targets a subvariant of Omicron."

The ATAGI also says XBB.1.5-containing vaccines are preferred over other COVID-19 vaccines.

An XBB.1.5-containing vaccine is not currently available for children aged six months to five years. However, a formulation has been approved for use and supply of it is anticipated in 2024.

But does one manufacturer have a slight edge over the other? Should people receive the same or the alternate option for their booster?

"In the end, which of those brands you choose doesn't matter," Dr Griffin says.

"Early on, there was some suggestion that if you went from one platform to another, there might be some benefit there.

"But these days we really only have one platform, and there are no significant measurable differences that should make someone pick and choose one over the other."

And as the virus continues to develop, experts say you should keep an eye out for updated vaccines.

There are a few different ways you can do this:

Through your Medicare account, you'll be able to see your COVID-19 vaccine certificates and also see a link to your immunisation history statement.

There are two COVID-19 oral antiviral treatments available:

The antivirals are used to help prevent COVID-19 infections from becoming severe.

They're typically prescribed to individuals who are at higher risk of severe disease if they become infected with COVID-19.

If you are 18 years and older and test positive for COVID-19, you may be eligible for an oral COVID-19 antiviral medicine if you:

You may also be eligible if you test positive for COVID-19 and you are:

It's not mandatory to wear a mask.

But Dr Frawley and Dr Griffin both agree masks are something to consider when travelling, especially if you're at high risk.

"They are still relevant, especially in crowded indoor areas where it's not always possible to avoid viruses like COVID-19 that spread easily through the air," Dr Frawley says.

Keep in mind some countries, airlines and vessel operators may have COVID-19 travel requirements in place.

Here's some other simple advice to take with you:

Here's how case numbers are tracking nationally.

According to the National Notifiable Disease Surveillance System (NNDSS), 45,007 cases were reported in Australia in May.

It was an increase of 24,300 on the previous month.

If we take a look at each state's individual COVID-19 surveillance system, all states (bar the Northern Territory which doesn't record COVID-19 data) have recorded a jump in cases over the past fortnight.

And what about overseas COVID-19 case numbers?

Here's a snapshot of some of the popular international tourist destinations (data from the World Health Organization):

But why are case numbers higher in Australia than the countries listed?

Dr Frawley and Dr Griffin say it is likely due to a few different factors:

Posted19h ago19 hours agoTue 11 Jun 2024 at 6:41pm, updated13h ago13 hours agoWed 12 Jun 2024 at 12:34am

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Travelling these school holidays? Here's when to get your COVID booster - ABC News

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Public urged to get XBB vaccine amid surge in COVID-19 cases - Focus Taiwan

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New COVID variant KP.3 is on the rise: Here's what to know - USA TODAY