Category: Covid-19 Vaccine

As Novavax emerges from its transition year in 2023, the vaccine maker is still raising concerns among Wall Street investors in early 2024.

The company's loss per share of $1.44 exceeded analyst expectations of 45 cents per share, CNBC reports, while its fourth-quarter revenues of $291.3 million came short of the analysts'estimate of $322 million.Novavax's stock was trading down by about 23% just before 9 a.m. ET on Wednesday.

Amid plummeting COVID vaccine demand, Novavaxlast year initiated cost cuts, manufacturing modifications and laid off 30% of its workforce.

In all, the vaccine makerreducedits full-year 2023 operating expenses by $1.1 billion, or 41%, versus 2022, the company saidin an earnings release Wednesday. Through aggressive cost-cutting, Novavax exceeded the goal for its previously stated savings plan by $150 million across R&D and selling, general and administrative (SG&A) expenses.

On the revenue side, Novavax generated $984 million last year, down from the $2 billion it scored over the same period in 2022. Last year's total net loss came to $545 million, showcasing why the company has been so focused on cutting costs.

Looking ahead, Novavax aims to generate sales between $800 million and $1 billion in 2024. The company expects total first-quarter revenue to clock in at approximately $100 million.

Novavaxs restructuring scheme comprises one of three priorities the company set out to complete in 2023.

Elsewhere, the company also angled to deliver an updated COVID-19 vaccine for the 2023 fall vaccination season. It also seeks to leverage its technology platform and portfolio to create a future beyond its pandemic shot Nuvaxovid.

To the first point, the U.S. FDA expanded its emergency use authorization (EUA) to include Novavaxs updated protein-based shot in early October. Novavax says it subsequently gained commercial experience in the U.S. and has made efforts to recalibrate its U.S. field teams for the commercial COVID shot market.

In the company's pipeline, Novavaxis working on a COVID and flu combo shot.

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After steep cost cuts, Novavax's fourth-quarter performance falls short of expectations - FiercePharma

The main covid-19 vaccines seem to have a net positive effect on our heart health

Fly View Productions/Getty Images

Many covid-19 vaccines appear to reduce the risk of heart attacks, strokes and other blood clot conditions for at least six months, according to a study of the health of about 46 million people amid the coronavirus pandemic. This is despite them causing rare side effects that affect the heart and blood clotting system.

The net benefit to heart conditions most probably happens because the vaccines protect against severe covid-19, which itself can cause heart attacks,

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Covid-19 vaccines seem to cut the risk of heart attacks and strokes - New Scientist

The watchdog also saw a signal for the heart problems myocarditis and pericarditis in February 2021, but did not include the conditions in safety updates until June 2021, MPs said.

In effect, the MHRA licences medical products as safe knowing it lacks the processes to properly monitor adverse events, the APPG wrote.

In the case of Covid-19 vaccines, given the comparatively novel technology and record manufacturing speed, could the MHRA have even properly scrutinised the licensing data or known the short term safety?

Historically trust and confidence in vaccines and vaccine safety has been high in the UK, but it seems that the experience of the Covid-19 vaccines has undermined this and by association trust in the regulator and the pharmaceutical industry.

Now more than ever a wide-reaching and in-depth review is needed.

The group also warned that the MHRA Yellow Card reporting system which encourages patients and doctors to flag-up medicine side effects grossly underestimates complexities, and in some instances picks up just one in 180 cases of harm.

An analysis by Stockport NHS Foundation Trust found that in the North West of England, 1,058 people had been admitted to hospital with stomach bleeds caused by anticoagulant medication over five years, yet just six Yellow Card reports were made during the period.

Side effects from drugs account for one in every 16 hospital admissions in Britain, and cost the NHS more than 2 billion each year.

But trials are often too small to pick up adverse reactions, particularly when they are driven by rare genetic mutations, meaning it is vital to continue monitoring drugs in the community.

The MHRA recently said it would investigate why blood thinners were causing dangerous side effects in between two and five per cent of patients.

The APPG said it was also concerned that MHRA regulation of medicine was funded by the pharmaceutical industry and said the body had shifted from focusing on scrutiny to trying to help drugs get approved.

Dame June Raine, the chief executive of the MHRA, who announced she would be stepping down last week, has previously said the agency was transitioning from watchdog to the enabler, a phrase which MPs said warranted its own investigation.

Graham Stringer MP, co-chair of the APPG on pandemic response and recovery, said:

The MHRA oversees a failing system that is slow to act, causing harm to patients and beset with conflicts of interest.

We cannot allow it to continue. Thats why we have written to the health select committee calling for an urgent investigation into the MHRA.

The APPG said that concerns raised directly with the MHRA had been met with an habitually dismissive and evasive response.

Dame June said: We have made significant steps to put patients at the heart of all our work.

These include incorporating patient views and lived experience into our safety reviews; involving patients in the early stages of planning medicines development and building a new responsive reporting system for patients to tell us about any adverse incidents. We have also led on legislative changes to strengthen surveillance for medical devices and medicines, meaning patient safety is embedded firmly into law.

Our progress so far in making changes based on meaningful patient involvement gives us a solid base to build upon as we continue on this important journey.

We are committed to enabling innovation that brings transformative medical products safely to patients.

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Medicines regulator failed to flag Covid vaccine side effects and must be investigated, say MPs - The Telegraph

The culture of public health and medicine rests on open discussions in which different points of view are considered for the betterment of patient care and health. This process depends on psychological safety so individuals feel free and safe to speak and openly disagree. These factors collectively create a just culture, which improves systems and organizations and is being widely implemented in healthcare nationwide.

However, in the face of politicized anti-science and anti-expert sentiment and attacks, we need to ask if just culture is being restricted in public health. Following a series of legislative policy changes in Florida affecting academic institutions, health care, and public health, we see a regression in the open dialog of medical and public health experts about infectious disease control practices related to COVID-19 and now measles.

On January 3, 2024, in marked opposition to the CDC, FDA, and medical and public health experts, State Surgeon General Dr. Joseph Ladapo recommended that everyone avoid COVID-19 mRNA vaccines over concerns that they contain DNA. This notion starkly contrasts ample scientific data showing that these vaccines do not alter a persons genes, even if they contain minuscule amounts of DNA related to vaccine production. This announcement came on the heels of an earlier announcement on September 13, 2023, recommending that individuals younger than 65 not receive the updated COVID-19 vaccine, even though 25% of COVID-19 deaths have occurred in those younger than 65. Previously, he recommended that young adult men avoid the vaccine because of concerns about myocarditis. However, this risk of myocarditis is very rare, and the risk of myocarditis following COVID-19 is far greater than after vaccination.

Following these announcements, there was broad national criticism of these Florida-only policies. In contrast, the response by the Florida medical and public health community to these controversial recommendations, either in support or opposition, was modest. This tepid response contrasts the first years of the pandemic, when Florida medical organizations, medical schools, and public health experts often commented publicly about the state's COVID-19 mitigation and vaccination policies.

Currently, there is ameasles outbreakin a South Florida elementary school. Dr. Ladapo, not the county health officer, has stated that children at high risk for getting measles can attend school while potentially being contagious,leaving the decision to the parents. Although we are early in this outbreak, we are observing a similar situation where there is considerablenationaloutcry against his recommendation, while the response from the Floridamedical communityislimitedto afew practitioners.

Measles is a very contagious virus, 5 to 10 times more contagious than COVID-19, as it travels long distances and lingers in the air for hours. If an unvaccinated individual is exposed, there is a very high chance that the person will get the virus, which can result in encephalitis, pneumonia, and hearing loss.

Reflecting anti-vaccine and anti-science activity that has become part of the political agenda, rates of measles vaccination among young children have fallen below critical levels in many parts of the US. Not surprisingly, there has been a recent rise in measles cases in the US. The medical community overwhelmingly supports childhood vaccinations but is drowned out by policies that weaken vaccination requirements and misinformation that erodes confidence in vaccines.

Measles outbreaks can be controlled through early post-exposure vaccination measures and quarantining unvaccinated and exposed individuals for 21 days, spanning the incubation period. This recommendation is based on the fact that individuals with measles can be contagious for several days before they show symptoms. Even though more than 90% of the population may be vaccinated against measles in some parts of the U.S., those who are unvaccinated or medically compromised are at high risk if exposed, irrespective of community vaccination rates.

Having a child out of school for three weeks is a long time. Yet, coming out of the pandemic, we have widely available tools to facilitate remote learning, which the school has implemented. When parents do not feel comfortable that an outbreak can be controlled, it is natural for them to keep their children out of school. It was reported that almost 20% of the student body was absent several days after this outbreak, even in this school, which had previously reported high vaccination rates. Was it considered that emphasizing standard measles control policies are being followed, rather than allowing children with potential measles to go to school, could boost attendance?

We need to ask what has happened over the past year to discourage the airing of views contrary to state policies. Is there self-censorship or external censorship? Was there opposition to these recent recommendations by Dr. Ladapo from inside the Florida Department of Health? The answer may lie in reviewing recent legislative and state actions that may give medical experts and those at academic institutions pause in speaking out.

First, a law was passed allowing faculty tenure to be revoked at state universities, meaning faculty with secure positions can now be fired. Florida University faculty members have stated that this policy limits the freedom of experts to speak openly over fears of retribution.

Second, the Medical Freedom bills signed into law in Florida on May 11, 2023, now allow physicians to make public, unsubstantiated, and false claims without consequence. Medicine has regulated itself to keep the public safe. Without these guardrails, inaccurate information can increase without the proper checks of hospital credentialing boards and medical societies. Does this new law make physicians powerless to challenge false and potentially harmful medical information?

Third, the state regulateshospital fundingandMedicaidpatient care reimbursement rates. University, medical school, and hospital leadership administrators may thus be concerned when faculty members speak publicly and run afoul of political leaders.

Fourth, we see the state dictating what can and cannot be taught at K-12 schools and public universities, something unheard for college and universities in the past. Recently, the Florida Board of Governors banned sociology from the core curriculum of the university system. Considering that the most popular majors at the University of Florida, for example, are psychology and biological sciences, for which sociology is foundational, one needs to ask if the state policy is in the students best interest.

Fifth, healthcare providers are now being drawn into culture wars. Medical organizations are also being investigated for health-related issues at the state and national levels.

We now see what happens when policies threaten the perceived ability of medical experts, university experts, medical societies, and public health employees to speak openly. Public discussion about crucial public health state policies fades.

Florida once took its place among the states with the highest COVID-19 vaccination rates for those older than 65 in the US and was among those with the lowest COVID-19 death rates per capita, ranking 29th in the spring of 2021. In contrast, Florida currently has one of the lowest booster COVID-19 vaccination rates in the U.S. and ranks 8th in COVID-19 deaths per capita. Now, Florida has a serious measles outbreak and is not following standard measures of infection control by allowing potentially contagious children to return to school.

Consideringthe high vaccination rateof 97% at the outbreak site, this outbreak will be contained. But what will happen when measles lands in a school or community with lower vaccination rates and standard public health measures need to be followed?

Do we really want to limit discussions about infectious disease control policies? We have learned the clear advantages of a culture that considers different viewpoints in medicine and public health.

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Florida's War on Public Health | TIME - TIME

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Louisiana public health officer who championed COVID vaccines resigns - Shreveport Times

Senate Bill 295, filed by Smithfield Senator Lindsey Tichenor, is being billed as a medical freedom measure.

In a statement, Tichenor argues Kentucky citizens were "forced to make compromising health decisions in order to retain their employment, gain access to medical treatment, or to enroll in schools during the response to the pandemic." The bill would block compulsory COVID or mRNA-based vaccinations in those instances.

The lawmaker goes on to call the vaccines "ineffective" and "dangerous."

SB 295 represents a pivotal step in addressing the complexities surrounding vaccination mandates and underscores the importance of preserving individual liberties in the face of public health challenges, Tichenor wrote.

The largest study to date of COVID vaccine safety looked at nearly 100 million vaccinated people across eight countries. The World Health Organization's Global Vaccine Data Network examined 13 medical conditions, including myocarditis, convulsion, and Guillain-Barr syndrome and found elevated risks associated with the vaccines.

Even with the findings, however, researchers concluded the risks from COVID-19 itself remain much higher than the risks of adverse events.

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Kentucky bill bars COVID vaccination mandates in certain situations, citing risk of adverse events - WUKY

(Precision Vaccinations News)

The US Food and Drug Administration (FDA) announced in a post on X that on May 16, 2024, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will hold a public discussion to recommend the selection of strain(s) to be included in the 2024-2025 formula for COVID-19 vaccines.

On February 26, 2024, the FDA confirmed that changes to the vaccine composition may be necessary based on the currently circulating strains of the virus that causes COVID-19.

After receiving any recommendations from the VRBPAC regarding the 2024-2025 formula update, the FDA plans to take appropriate regulatory actions on updated COVID-19 vaccines so that manufacturers can make them available by September 2024.

The FDA expects that the composition of COVID-19 vaccines may need to be updated annually, as is done for seasonal influenza vaccines.

Background material and the link to the online teleconference and/or video conference meeting will be available on theAdvisory Committee calendar no later than twobusiness days before the VRBPAC meeting.

Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Eastern Time.

Contact Information:Sussan Paydar or Prabhakara Atreya, Center for Biologics Evaluation and Research, FDA, 202-657-8533 or[emailprotected].

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US FDA to Review COVID-19 Vaccine Formulas on May 16, 2024 - Precision Vaccinations

As the world navigates through the lingering mist of the COVID-19 pandemic, a groundbreaking study has emerged, casting a new light on the voyage we've embarked upon with mass vaccination. This exploration, encompassing the health data of approximately 46 million souls, reveals a compelling narrative about the vaccines designed to shield us from the virus's wrath. It's a tale of protection against severe illness and an unexpected champion of heart health, despite unveiling a slight uptick in certain medical conditions.

The study in question unfurls a tapestry of data illustrating that vaccines not only arm us against COVID-19 but also fortify our defenses against heart attacks, strokes, and other menacing blood clot-related conditions for a span extending at least six months post-administration. This revelation is particularly poignant, considering the virus itself can set the stage for serious cardiovascular complications. The essence of this discovery lies not merely in the numbers but in the lives potentially saved by this dual protection.

Yet, no journey is without its perils. The study acknowledges a slight increase in the risk of certain conditions, including Guillain-Barr syndrome, Bell's palsy, convulsions, myocarditis, and pericarditis, attributed to the vaccines from Moderna, Pfizer-BioNTech, and AstraZeneca. Myocarditis cases, for instance, showed a notable increase following the second dose of Moderna's vaccine. However, the narrative takes a turn when considering these adverse effects remain significantly rarer compared to the risks posed by the virus itself. The dialogue surrounding vaccine safety is nuanced, emphasizing that while the journey is not devoid of risk, the path of vaccination leads to a greater safeguard against the tempestuous seas of COVID-19.

In the wake of these findings, the medical community and public health officials remain steadfast in their support for vaccination. The Global COVID Vaccine Safety project, backed by esteemed institutions, steers this ship with a clear message: the benefits of COVID-19 vaccination far outweigh the potential risks. This stance is not born out of complacency but from a rigorous examination of the data at hand. As we venture further into this uncharted territory, the potential for refining vaccine formulations and administration strategies illuminates the horizon, promising smoother seas ahead for global health.

In essence, the study underscores the critical importance of vaccination in our collective battle against COVID-19. It serves as a reminder of the vaccines' role not just as a shield against the virus but as a beacon of hope for preventing the heart-related storms that the virus can provoke. As we continue to sail through these turbulent times, the key to navigating safely lies in heeding the science, understanding the risks, and embracing the protective embrace of vaccination.

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Navigating the Waters of COVID-19 Vaccination: A Heartfelt Perspective on Risks and Rewards - Medriva

Moderna (MRNA) shares surged in early trading on Thursday after posting better-than-expected fourth-quarter results. The biotech company reported a surprise profit in the quarter, with CEO Stphane Bancel telling Yahoo Finance Live that "last year was a transition year" for the company.

Oppenheimer & Co. Biotechnology Analyst Hartaj Singh argues that investors should focus less on the Covid-19 business and more on the company's pipeline, given that this should be "a trough year" for Covid-19 vaccine revenues. Singh believes that over the next 6 to 9 months, there will be "a relentless discussion" around the company's pipeline, which he says is "great" given that he thinks "this should be a five-product company in 2026."

Watch the video above to hear why Singh says Moderna is the "kind of stock you want to own."

For more expert insight and the latest market action, click here to watch this full episode of Yahoo Finance Live.

Editor's note: This article was written by Stephanie Mikulich.

- Shares of Moderna up just about 6.5% this morning after reporting better than expected sales when it comes to the estimates that we got here from the street. Now, all of this coming despite the fact that sales for its COVID-19 vaccine pulled back just about 43% from a year ago.

Yahoo Finance spoke with Moderna CEO, Stphane Bancel, about the decline in COVID vaccines. And here's what he had to say.

STPHANE BANCEL: I think we can do much better as a company and also working with public health leaders to increase vaccination rates. Americans need to know, if you are 65 and above, you have five times more chance to get hospitalized because of COVID than because of flu. And as you know, many more people take a flu shot than a COVID shot, so we have to do better there.

- All right, for more on these results, we want to bring in Hartaj Singh, he's Oppenheimer's biotechnology analyst. Hartaj, it's great to see you here. So I'd love to get your reaction to what we just heard from Stphane Bancel and also just putting this in perspective for us. Because over the last couple of quarters, we've talked about the fact, the risk of the decline in the uptake here of COVID-19 vaccines, what that risk or challenge them poses here to Moderna. Are we starting to see that narrative shift just a bit as we get more positive results on RSV? And also some of the excitement surrounding its cancer immunotherapy.

Story continues

HARTAJ SINGH: No, thank you, Seana. And I really appreciate you all having me as always. You know, look, here's the thing, this has been a story around COVID-19 vaccines, the sales, and the underlying trends. When we upgraded earlier this year, we basically said that, look, this is a story that this year will change from COVID-19 vaccine trends and COVID-19 vaccine revenues to basically a pipeline story and with the company being potentially a five product company in 2026.

And I think today what you saw was they reported COVID-19 vaccine revenues that were in line with what we were expecting. This probably should be the trough year. On the call, the company reiterated their guidance for the full year of 2024. And especially I think in January and February, it didn't seem like there was any big change to vaccination trends one way or another. That should give us pause that this should be a trough year for COVID-19 vaccine or COVID vaccine revenues.

The second part to your point that more and more, the conversation is coming up on their pipeline. On conference calls, investor calls, 70%, 80%, 90% of the questions used to be on COVID-19 vaccine revenues. Now, people are talking about flu. Phase two will read out this year. The combination flu and COVID-19. A phase three will read out later this year. CMV cytomegalovirus, this is for pregnant women. That will hopefully read out later this year. And cancer vaccines, rare diseases, those are trials that are initiating.

So you can already see suddenly the change happening where we're going from discussing COVID-19 revenues and vaccination trends relentlessly like Stphane was talking about to now really talking about the pipeline.

- Well, the shares right now down by about 41%, investors waiting for that pipeline story to really ring through to some of the financial results. So where are we in the mRNA platform, messenger RNA as a platform and iterating on top of what they already have to really bring some of these new solutions, treatments to market?

HARTAJ SINGH: Yeah, but so the mRNA platform is a really good question, and it matters in a way. So as a biotech analyst, what does a platform mean to me?

A platform means that the company has an approach with either a type of a molecule. For Regeneron with antibodies. Gilead, infectious diseases. Vertex, they're agnostic but they go after understanding disease pathology. With Moderna, it's the mRNA. And what does that mean? What that means is you should be able to shorten development times, increase the probability of success for your development candidates that follow the first approval, in which in this case, it was the COVID-19 vaccine revenues. Sorry, vaccines.

If you go back to the R&D slides from last year, you'll see that that's exactly what they're doing. As they're developing products in RSV, in flu, in combo vaccines, in cancer vaccines, in rare diseases, they're shortening the development times and they're increasing their probability of success.

So we're already seeing that this is a company that's beating historical estimates. And that's the kind of stock you want to own if you're a kind of a mid to long-term holder because that means that every product will just get on market faster with a higher degree of certainty.

- Right. Cutting down some of the R&D costs as well along the way here. So for investors that are looking around that time horizon, how far out should they be looking?

HARTAJ SINGH: Look, the first six to nine months here is really just going to be all about the pipeline. We're not going to see COVID-19 sales until-- the insights there until about the second quarter call in late July or even the third quarter call in late October.

So really, the discussion about next six to nine months are going to be all centered around the pipeline, which I think is great because people are now going to start getting comfortable with the idea that they should have a flu vaccines approved next year, RSV approved this year, a combination vaccine flu and COVID-19 approved next year. Cytomegalovirus vaccine possibly approved next year. The readout is good later this year.

So what we're going to see now is a relentless discussion next six to nine months around the pipeline and these projects. So we should start seeing it very quickly. And our upgrade stated in January, a couple of months ago, that this should be a five-product company in 2026. And the update today underlined our conviction there.

- Oppenheimer analyst, Hartaj Singh. Hartaj, thanks so much for taking the time here today to break down the Moderna results. Certainly appreciate it.

HARTAJ SINGH: Thank you for having me.

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Moderna rises on Q4 results: Focus on the pipeline, analyst says - Yahoo Finance

Key points:

Moderna reported a surprise profit in the fourth quarter of 2024, with earnings of 55 cents a share, a decrease from $3.61 a share in the same quarter a year ago. The company's net income exceeded expectations, despite a decline in sales of its Covid-19 vaccine, Spikevax. Revenue for the quarter was $2.81 billion, down from $5.08 billion in the year-ago quarter, but above projections for $2.51 billion.

The company's Covid-19 vaccine netted $800 million in U.S. sales and another $2 billion in international markets. The quarter also included the recognition of $600 million in deferred revenue related to Gavi, the Vaccine Alliance, an international organization created to improve vaccine access for children in poor countries.

Moderna's cost-cutting efforts and deferred payments contributed to the surprise profit. The company also set out a commercial roadmap for its vaccines in Europe and its experimental respiratory syncytial virus (RSV) shot. Moderna expects a U.S. approval decision for its RSV vaccine by May 12 and plans to launch the RSV shot in Germany and Australia this year.

Data posted earlier this month showed the RSV vaccine was 63% effective at preventing RSV-related respiratory symptoms after 8.6 months, down from 84% at 3.3 months. Moderna also expects data from late-stage trials of its next generation COVID shot and its cytomegalovirus and COVID-flu combination vaccines this year.

Despite the decrease in earnings and revenue, Moderna reaffirmed its 2024 forecast of $4 billion in sales, the lowest figure for annual revenue since its COVID vaccine got U.S. emergency authorization in late 2020.

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Moderna's Unexpected Q4 Profit TradingView News - TradingView