Novovax, the maker of the only protein-based COVID-19 vaccine available in the US announced that its shot is on track for full approval from the US Food and Drug Administration (FDA). It is an important development for the company. It has sent its stock soaring up to 21% on Wednesday morning for trading. It is said that this will also ease the fears of political interference that may have caused delay in the process.

Vaccine For Emergency Use Only

While the other mRNA vaccines from Pfizer and Moderna have received full FDA approval for specific age groups, Novovax's vaccine still awaits the approval. It is only authorized for emergency use.

The emergency use authorization or the EUA allows vaccines to be distributed during public health emergencies. However, once the emergency ends, the FDA can remove them from the market unless full approval is granted.

Why Did The Delay Happen?

The FDA originally planned to approve Novovax's vaccine by April 1. However, as per the inside sources, the process was paused at the direction of Dr Sara Brenner, the FDA's acting commissioner. The delay has also raised concerns, especially after Dr Peter Marks, the FDA's longtime vaccine chief, reportedly left his post due to disagreements with the Health Secretary Robert F Kennedy Jr, who is a known vaccine skeptic.

What Makes Him A Vaccine Skeptic?

In the past, RFK Jr. has worked closely with many anti-vaccine activists who work for his nonprofit group Children's Health Defense. While in his recent speech, he said that he has "never been anti-vax and have never told the public to avoid vaccination", his track record shows otherwise.

In a podcast interview, he said, "There is no vaccine that is safe and effective" and told FOX News that he still believes in the now long-debunked idea that vaccines can cause autism. In another 2021 podcast, he urged people to "resist" CDC guidelines on getting their kids vaccinated. "I see somebody on a hiking trail carrying a little baby and I say to him, better not get them vaccinated," he said.

His non-profit also led an anti-vax campaign sticker and he appeared next on the screen to a sticker that read: "If you are not an anti-vaxxer you are not paying attention," reports AP.

What Does The Vaccine Need For Approval?

The FDA recently asked Novavax to outline a plan to collect additional clinical data from people who have received the vaccine. Novavax says it is “engaging with the FDA expeditiously” and hopes to secure full approval as soon as possible. Full FDA approval is considered the gold standard, as it reflects a higher level of scrutiny and confidence in a product’s safety and effectiveness.

How Is This Vaccine Different From Others?

The COVID-19 vaccines that are currently available in the US teach the immune system to recognize the virus' spike protein, which is its outer coating. the Pfizer and Moderna's mRNA vaccine deliver genetic instructions that help the body create a temporary version of spike protein that trigger an immune response. In contrast, the Novovax's shot contains lab-grown copies of the spike protein itself, which are then combined with a substance that boosts the immune response.

This traditional approach—called a protein-based vaccine—has been used for decades in vaccines for diseases like hepatitis B and shingles. For people who are hesitant about mRNA vaccines, Novavax offers an alternative that uses a well-established method.

Five years after the peak of the global pandemic, the world continues to grapple with the evolving landscape of Covid-19. The latest twist comes from the United Kingdom, where a new strain dubbed ‘Stratus’ has rapidly become the most prevalent variant, accounting for nearly a third of all cases in England. What sets Stratus apart is not just its speed of spread, but a unique and unexpected symptom, a hoarse voice.

With experts warning of increased immune evasion and the World Health Organization (WHO) keeping the strain under close surveillance, the emergence of Stratus and its sub-variants XFG and XFG.3 is a timely reminder that the fight against Covid-19 is far from over.

What Is New Covid Variant Stratus?

First identified in January 2025, the Stratus strain—officially classified under the XFG lineage and its subvariant XFG.3—has become the most common form of COVID-19 in England. According to the UK Health Security Agency (UKHSA), the XFG.3 variant currently accounts for a greater proportion of cases than any other single strain, with Stratus overall making up roughly 30% of infections in the region.

The World Health Organization (WHO) has designated Stratus as a "variant under monitoring," a classification that signals the need for heightened genomic tracking, though it has emphasized the variant currently poses a low risk to global public health.

What sets Stratus apart from prior variants, particularly its Omicron predecessors, is a peculiar but increasingly common symptom: a hoarse or raspy voice, an anomaly not prominently associated with COVID-19 strains before.

Dr. Alex Allen, Consultant Epidemiologist at UKHSA, emphasizes that while viruses naturally mutate over time, the Stratus strain’s unique symptom profile and rapid spread warrant careful monitoring.

Stratus is not just another offshoot of Omicron; it is what scientists call a “recombinant” or “Frankenstein” variant. This means it emerged when an individual was infected with two different Covid strains simultaneously, resulting in a new hybrid lineage. Such recombination events are rare but can lead to variants with novel characteristics—including changes in transmissibility, immune evasion, and symptomatology.

Reports from the World Health Organization indicate that Stratus is showing signs of additional immune evasion compared to other strains. This means it may more effectively bypass existing immunity from previous infections or vaccinations, contributing to its rapid spread.

How Widespread Is Stratus Globally?

As of June 22, 2025, Stratus has been detected in 38 countries, according to the World Health Organization. In addition to its prevalence in the UK, it is showing a slow but steady increase in several regions across Southeast Asia and Europe, and health authorities in the United States are closely monitoring imported cases.

The WHO noted that several nations have reported rising case counts and mild upticks in hospitalization rates alongside increased detection of XFG. However, current evidence does not indicate that Stratus causes more severe illness or higher mortality than other circulating Omicron variants.

As of late June 2025, Stratus accounted for 22.7 percent of global Covid-19 cases, according to the WHO. It has been detected in 38 countries, reflecting its global reach. The UK remains the epicenter, but rising case numbers have also been reported in South-East Asia, Australia, and several U.S. states.

The true scale of the spread, however, is difficult to measure. With widespread reductions in Covid-19 testing compared to the height of the pandemic, many cases may go undetected or unreported. This underlines the importance of genomic surveillance and international cooperation in tracking emerging variants.

Recognizing the Symptoms of Stratus Strain

While the hoarse voice is the most distinctive symptom reported with Stratus, health authorities have not yet listed any other unique symptoms for this variant. The classic symptoms of Covid-19—including fever, persistent cough, loss of taste or smell, fatigue, headache, and sore throat—remain common.

The NHS continues to advise the public to watch for:

• High temperature or shivering
• New, continuous cough
• Shortness of breath
• Loss or change in sense of smell or taste
• Feeling tired or exhausted
• Aching body
• Headache
• Sore throat
• Blocked or runny nose
• Loss of appetite
• Diarrhea
• Nausea or vomiting

The emergence of a hoarse voice as a prominent symptom highlights the need for ongoing vigilance and public awareness, especially as new variants may present in unexpected ways.

Is Stratus Variant More Dangerous?

So far, there is no evidence that Stratus causes more severe disease than previous variants. Dr. Alex Allen, Consultant Epidemiologist at UKHSA, stated that the agency continues to monitor the situation closely, adding, “It is normal for viruses to mutate and change over time.”

Dr. Allen also emphasized that COVID-19 vaccines in use remain effective against Stratus and its subvariants. While Stratus shows signs of “immune evasion,” experts clarify this doesn’t mean existing immunity—whether from vaccination or prior infection—is rendered useless. Instead, it may suggest slightly reduced protection against infection, not against severe illness.

The UK and many other countries continue to offer seasonal COVID-19 booster doses, especially for vulnerable groups. In the UK, the NHS is currently offering the vaccine to:

• Individuals aged 75 and above
• People aged 6 months to 74 with weakened immune systems
• Residents in adult care homes

The rationale remains the same: over time, vaccine-induced immunity wanes, and booster doses "top up" protection, reducing the risk of severe symptoms, hospitalization, and death.

As of now, there is no need for a new vaccine targeting Stratus, but virologists remain vigilant. The adaptability of mRNA vaccine platforms allows manufacturers to update formulations quickly, should a variant emerge that significantly escapes immunity.

While the Stratus strain doesn’t appear to be more deadly or vaccine-resistant, it’s a clear reminder that COVID-19 is not behind us. The virus continues to mutate, and new symptoms—like a hoarse voice—may require clinicians and patients to adjust their awareness of what infection might look like.

Public health experts advise individuals to stay up to date with vaccines, test if symptomatic (especially if vulnerable or in contact with high-risk individuals), and continue practicing good hygiene, particularly in crowded indoor spaces.

Kerala, which has a strong public health system in southern India, is yet again facing the threat of Nipah virus—a deadly, bat-spread zoonotic illness with high mortality rates. Two fresh cases in Malappuram and Palakkad have led the authorities to issue an alert in three districts: Malappuram, Palakkad, and Kozhikode. The swift mobilization of health resources and containment measures attest both to the seriousness of the threat as well as lessons gleaned from past outbreaks.

This return of the virus, with a high fatality rate and a zoonotic mode of transmission, has renewed debate around viral spillovers, ecological disturbance, and the tenuous equilibrium between human activity and wildlife interaction.

The first official case is that of a 38-year-old Malappuram woman, who was tested positive at the country's top virology lab, the National Institute of Virology (NIV) in Pune. The woman, who first reported fever almost three weeks ago, visited three different healthcare centers, including a local clinic. The woman is now undergoing intensive care at Perinthalmanna's private hospital.

The second case, unfortunately, is that of a child from Palakkad who died due to the infection. Postmortem examination revealed Nipah virus to be the killer. Clinical history and contact history of the child are being evaluated as health officials scramble to determine the spread of the outbreak.

As a precautionary measure, three districts—Kozhikode, Malappuram, and Palakkad—have been put in high alert. Kerala Health Minister Veena George confirmed that contact tracing and containment procedures are already underway. The samples of both the cases have also been sent to the National Institute of Virology for reconfirmation.

345 people have been identified in the contact network as per Minister George—211 from Malappuram, 91 from Palakkad, and 43 from Kozhikode.

A travel history map of the Palakkad patient was released, enabling the authorities to step up containment and isolation measures. In a first-ever initiative, 26 specialist response committees have been deployed in every affected district. These consist of task forces for epidemiological surveillance, hospital readiness, public communication, and coordination with law enforcement.

Police forces have also been asked to work closely with the health apparatus to facilitate smooth implementation of movement restrictions, testing, and quarantine measures, if the situation demands.

District Collectors have been authorized to declare containment zones as a precaution, with teams to implement lockdowns at micro levels based on risk assessment.

Nipah virus infection poses a daunting diagnostic challenge. Early presentation—fever, headache, sore throat, and respiratory distress—is indistinguishable from that of routine viral infections such as influenza. Severe illness can quickly evolve into encephalitis, seizures, and coma within 24 to 48 hours. Incubation is 4 to 14 days but can be up to 45 days, making it difficult to trace and contain transmission.

Kerala has enforced strict surveillance measures. All contacts are risk-stratified: high-risk contacts (who had contact with body fluids or spent extended hours with a confirmed case) are home quarantined with active monitoring for 21 days, and symptomatic contacts are placed in specialized isolation facilities right away.

Nipah virus first appeared in Kerala in 2018, and since then the state has suffered five outbreaks, claiming 22 lives and leaving only seven alive. The virus is mainly spread from fruit bats (Pteropus species) to humans, though it can also be spread through food contact or human-to-human transmission. Kerala's distinctive ecology—highly populated forests, large bat presence, and frequent human-wildlife interaction—is especially susceptible to spillover events.

A new study in PLOS Global Public Health discovered that four out of six Nipah outbreaks in Kerala since 2018 occurred during El Niño years and the time of fruit ripening (May–September), highlighting the influence of environmental determinants on outbreak patterns. Deforestation, habitat destruction, and climate variability are suspected to enhance the risk of bat-to-human transmission.

This is not the first time Kerala has fought against Nipah. The state has already encountered five outbreaks since 2018. Among the 29 reported cases, 22 ended in deaths, with seven individuals surviving the infection.

The Nipah virus, which was first detected in 1999 in an outbreak among pig farmers in Malaysia, is a zoonotic virus. The natural reservoir in India is the Pteropus fruit bat or Indian flying fox. Humans get infected through direct contact with bats, their secretions, or intermediate hosts like domesticated animals.

What makes Nipah particularly sinister is the 40% to 75% mortality rate and the fact that it is hard to detect in its early stages because of its resemblance to typical viral fevers. The initial symptoms are fever, headache, and muscle aches, which may progress rapidly to encephalitis (inflammation of the brain), respiratory failure, and death. There is no cure or vaccine as yet, making control and prevention the only feasible measures.

Nipah outbreaks in Kerala have in the past caused mass panic and, in some instances, destructive social practices. Misinformation and panic have during past outbreaks resulted in stigmatization of patients and their relatives and avoidance of health facilities. Health officials are thus putting efforts into open communication and public sensitization against fear, as well as promoting collaboration with measures of containment.

Nipah has a case fatality rate of 40% to 75%, ranking among the most lethal known viral infections. Survivors can have long-term neurological sequelae, such as chronic convulsions and personality disturbances. The high death rate and severity of disease emphasize the need for prompt detection and vigorous containment.

Global Lessons and the One Health Approach

Kerala's most recent outbreak highlights anew the value of the One Health strategy—an intersectoral, collaborative strategy that acknowledges the interrelatedness of human, animal, and environmental health.

Experts are urging steady investments in bat surveillance, conservation of the environment, and genomic monitoring for rising pathogens. Conservation of bat habitats and reduction of human exposure through safer agriculture practices and food handling standards might decrease future threats.

Globally, Nipah virus is a canary in the coal mine. With increasing climate change, deforestation, and urbanization, the risk of zoonotic viruses emerging and spreading is bound to rise exponentially.

In a significant stride toward curbing the spread of vector-borne diseases, India is moving closer to having its first indigenous dengue vaccine. The Indian Council of Medical Research (ICMR), in collaboration with Panacea Biotec, is on track to complete the enrollment of participants for Phase 3 clinical trials by October 2025, according to CNBC-TV18.

This crucial phase of testing, launched on August 14, 2024, marks the most advanced stage yet for the vaccine’s development. The multi-center, double-blind, randomised, placebo-controlled study is designed to assess the vaccine’s efficacy, safety, and long-term immunogenicity. So far, over 70% of the targeted 10,335 participants have been enrolled across 20 medical centers nationwide, according to CNBC-TV18 sources.

Two-Year Follow-Up Required Before Regulatory Submission

Once participant enrollment is completed, each subject will be monitored for a two-year follow-up period. This extended observation window, considered critical for evaluating the vaccine's long-term safety and effectiveness, is expected to conclude by the end of 2027.

According to CNBC-TV18, sources familiar with the development confirmed, “The enrollment process is progressing smoothly, and no safety concerns have been reported so far.”

Only after the follow-up period ends and the data are thoroughly analyzed will the findings be submitted to the Central Drugs Standard Control Organization (CDSCO) for regulatory review and potential market authorization. “If the vaccine demonstrates acceptable efficacy and a clean safety profile, it could then be considered for regulatory approval and subsequent launch,” CNBC-TV18 reported, quoting official sources.

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National-Scale Trial Across Premier Institutions

The Phase 3 trial is being carried out at reputed medical institutions located in major cities including Chennai, Pune, Hyderabad, Bengaluru, New Delhi, and Kolkata. According to CNBC-TV18, the study protocol stipulates a comprehensive two-year post-vaccination follow-up. The final data from this period will be crucial in determining the vaccine’s fate in the Indian market.

A Single-Dose Vaccine: What Is It All About?

What sets this vaccine apart from global counterparts is its single-dose formulation. This is expected to ease the logistical and financial challenges of mass immunization in dengue-endemic areas. Unlike international vaccines like Sanofi’s Dengvaxia and Takeda’s QDENGA—which require multiple doses and have limitations in efficacy across different dengue virus serotypes—India’s homegrown candidate offers a potentially more accessible and broadly applicable alternative.

Earlier phases of clinical evaluation, including Phase 1 and Phase 2 trials conducted in India, had already received regulatory clearance from CDSCO. These trials showed that the vaccine was both safe and capable of eliciting a strong immune response.

“India’s first dengue vaccine candidate has shown encouraging results so far. Phase 1 and 2 trials confirmed that the vaccine is safe and induces a protective immune response. We’re hopeful that Phase 3 will bring us closer to a much-needed tool in dengue prevention,” CNBC-TV18 reported, citing official sources.

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A Vital Step for a Country with High Dengue Burden

India continues to suffer from seasonal dengue outbreaks, with thousands of hospitalizations each year placing strain on public health infrastructure. The World Health Organization estimates about 390 million dengue infections occur globally each year, with India accounting for a significant portion. With no specific antiviral treatment available, prevention through vaccination and vector control remains the most effective strategy.

As per current projections, enrollment will wrap up by October 2025, followed by a two-year follow-up until the end of 2027. Only after this can ICMR and Panacea Biotec submit their formal application for market authorization, CNBC-TV18 noted.

If the vaccine passes regulatory scrutiny, it could revolutionize dengue control efforts not only in India but also in other low- and middle-income countries grappling with high disease burdens and limited access to effective vaccines.