Category: Vaccine

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Novavax’s 2nd round of job cuts reached 12% of staff, though execs say that should be it for now – FierceBiotech

February 2, 2024

Novavax says 12% of its workforce was cut as part of a second wave of layoffs announced at the end of 2023, bringing last years full-year staff reduction to about 30%.

The specific figure disclosed Wednesday morning adds clarity to the savings goal unveiled in November2023to bring general expenses and R&D costs below $750 million in 2024, a greater than 50% reduction from 2022 levels. The figure included $300 million in new reductions, the majority of which came from general expenses and R&D with an additional $100 million from reduced supply chain spending. Novavaxannounced in Maythat 25% of the team would be laid off.

In an interview with the companys management team at this years J.P. Morgan Healthcare Conference in San Francisco, CEO John Jacobs said those are all the cuts the company has in store for now.

The scaled-back spending is the byproduct of the COVID market crunch thats impacted all vaccine developers, including Moderna and Pfizer. Each company has had to write off billions in unused supply due to diminished demand. Novavaxs vaccine remains under emergency use authorization in the U.S., but Chief Operating Officer John Trizzino tentatively expects full approval in late August or September.

Company leaders maintain that these cuts were imperative to stay afloat and match the realities of the COVID market, while simultaneously providing enough capital to afford further development of a flu-COVID vaccine combo, with a phase 3 trial slated for humans later this year. That combo could launch as soon as 2026.

[2023] was stabilize, reduce expenses, streamline manufacturing, make sure we get the vaccine out the door...[and] positioning the company to independently bring forward our next piece of the pipeline, Jacobs said earlier this month.

Beyond the COVID and flu combo, Novavax has a malaria vaccine thats been recommended by the World Health Organization and Jacobs said the data gleaned by the combo shot should provide the option to make a standalone flu vaccine.

We've made dozens and dozens of antigens for different diseases, said President of R&D Filip Dubovsky, M.D. The question then is just making sure we choose the right one that people need.

He added that it wouldnt be a stretch of imagination to think the company was working on an RSV component to include in a future combo shot or standalone vaccine. If that happens, it would be a story of redemption, after the company flunked a phase 3 trial testing an RSV F-protein vaccine back in 2016.

We are working with a number of partners, both internally and externally, to evaluate different vaccine candidates with our adjuvant, Dubovsky said.

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Novavax's 2nd round of job cuts reached 12% of staff, though execs say that should be it for now - FierceBiotech

Gaithersburg COVID vaccine maker Novavax cuts more jobs – WTOP

February 2, 2024

Gaithersburg, Maryland-based Novavax, which announced a restructuring that included cutting its workforce by 25% last year, is adding to layoffs.

Gaithersburg, Maryland-based Novavax, which announced a restructuring that included cutting its workforce by 25% last year, is adding to layoffs.

Novavax will eliminate 12% of its remaining workforce, including 9% of its current full-time employees and the remainder contractors and consultants.

The cuts will take place this quarter, and, combined with previous job cuts, will mean it has reduced its workforce by about 30% since last year.

Novavax said in a statement it intends to bring its research and development, and general expenses below $750 million this year, but is still committed to delivering its COVID-19 vaccine and advancing its combination COVID-19-influenza vaccine.

With our mission to protect global public health at the forefront of all that we do, the new Nova is being designed to be a learner and more agile organization, chief executive John Jacobs said in a statement. We are redefining how we do business and are purposefully focusing only on the critical activities need to achieve our objectives and strengthen the financial performance of the company.

Novavax reduced operating expenses by 47% last year.

Novavax will report its fourth quarter results in February. The companys third quarter revenue was $187 million, most of which was from grants, compared to $735 million in the same quarter a year earlier. It cut quarterly losses to $131 million from $169 million a year earlier.

The companys updated COVID-19 vaccine received U.S. regulatory approval last fall, and is available in more than 14,000 pharmacies. Novavax will begin Phase 3 clinical trials for its combination COVID-flu vaccine in the second half of this year, with approval possible as early as 2026.

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Gaithersburg COVID vaccine maker Novavax cuts more jobs - WTOP

Updated Covid vaccine has 54% effectiveness, new study suggests – STAT

February 2, 2024

New data released Thursday by the Centers for Disease Control and Prevention suggest that the most recent Covid-19 booster offers about 54% percent protection against infection with the virus.

A study published in the CDCs online journal Morbidity and Mortality Weekly Report showed that the updated vaccine was essentially equally effective at protecting against the strain targeted by the vaccine called XBB.1.5 and the JN.1 subvariant, which emerged after the vaccine was made. JN.1 is currently the dominant virus circulating in the United States.

Ruth Link-Gelles, an author of the study, said it shows that the latest Covid shot offers significant protection to recipients.

We know that Covid is continuing to cause thousands of hospitalizations and hundreds of deaths in this country each week, Link-Gelles, the vaccine effectiveness program lead in the CDCs National Center for Immunization and Respiratory Diseases, told STAT. And 50% added protection against Covid-19 is really going to be a meaningful increase in protection, especially for those at highest risk.

Arnold Monto, a veteran vaccine effectiveness researcher at the University of Michigan, said the findings are what are expected at this point for Covid vaccine boosters.

Were moving into the era of 50%, 60% percent efficacy. Reminds you of flu [vaccine], doesnt it? Monto said.

Link-Gelles agreed with the analogy, noting that in a good year, influenza vaccines offer protection in this range. So this is kind of exactly where we would expect it to be for a vaccine for a respiratory virus in a population that has some underlying immunity to that virus.

The study used what is called a test-negative design, looking at 9,222 people with Covid-like symptoms who were tested for the virus. Of those, nearly 3,300 tested positive for Covid and the results were calculated based on a comparison of those who had received the booster versus those who had not.

The vaccine effectiveness was 58% among people who were tested between seven and 59 days after having received a shot, and 49% among those who were tested 60 to 119 days after receipt of the vaccine. The differences were not statistically significant, but the article suggested that given what has been seen previously with Covid vaccination, a reduction in protection is expected over time.

Because consistent patterns of waning VE vaccine effectiveness were observed after original monovalent and bivalent Covid-19 vaccination, waning of VE is expected with more time since updated vaccination, especially against less severe outcomes such as symptomatic infection, the article said.

Though Covid transmission has begun to subside somewhat in the country, Link-Gelles said people who have not yet received the latest version of the vaccine should still do so. Especially for our highest-risk individuals people who are pregnant, people who have high-risk conditions its really important to go out if you have not already and get that vaccine this year.

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Updated Covid vaccine has 54% effectiveness, new study suggests - STAT

Novavax to cut 12% of its global workforce – PharmaLive

February 2, 2024

Novavax to cut 12% of its global workforce

The company said the job cuts would impact both full-time employees and contractors.

Once completed, Novavaxs workforce would be about 30% lower compared to its workforce at the end of the first quarter of 2023.

The vaccine maker had 1,992 full-time employees as of Feb. 21, 2023, according to the latest annual regulatory filing.

Novavax said the decision is part of its intention to bring down its expenses below $750 million this year, which the vaccine maker had disclosed during its third-quarter earnings call in November.

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Novavax to cut 12% of its global workforce - PharmaLive

An Alarming Rise in Measles Cases Is Being Driven By Low Vaccination Rates – Scientific American

February 2, 2024

UK health services are battling an outbreak ofmeasles causing alarm in a nation that had eliminated the disease in 2017.

On 19 January, the UK Health Security Agency (UKHSA), the public-health authority, declared a national incident over rising cases of measles. The agency has logged more than 300 cases in England since 1 October 2023.

A decline in uptake of the measles, mumps and rubella (MMR) vaccine, which is given in two doses, during the COVID-19 pandemic has spurred the spread of the disease across England and the rest of Europe, while small outbreaks have occurred in a handful of US states.

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Measles is caused by a virus and is highly contagious. It is spread through coughing and sneezing. Symptoms include a fever, a runny nose and an itchy rash of red-brown spots. Its considered to be one of the most infectious respiratory infections there is, says population-health researcher Helen Bedford at University College London. Those most at risk include babies, young children, pregnant people and those with a weakened immune system.

Natureexplores the uptick in cases.

Low uptake of the measles vaccine is a key driver of the UK measles cases, say researchers. Around 85% of children in England have received two MMR vaccine doses by five years old, according to data from the National Health Service (NHS). This falls below the vaccination rate of at least 95% needed to achieve herd immunity which substantially reduces disease spread as recommended by the World Health Organization (WHO).

It is worrying but not all that surprising to see another measles outbreak within the UK, paediatrician Ronny Cheung at the Evelina London Childrens Hospital said in a statement to the UK Science Media Centre. The fact remains that vaccination coverage for children under the age of 5 is now the lowest it has ever been in the past 10 years, he said.

The COVID-19 pandemic worsened matters, says Bedford. At first, the number of measles cases dipped because of social-distancing measures. But vaccine uptake also dropped, contributing to the latest surge, she says.

Moreover, anti-vaccine messaging during the pandemic caused some people to question vaccine safety, which might have delayed uptake, says Bedford. People have got more questions, which, unfortunately, due to cuts in public-health funding, arent always properly addressed, she says.

On 22 January, the NHS launched a vaccination campaign, urging millions of parents and carers to book vaccine appointments for their children. Health services will contact all parents of unvaccinated children aged 6 to 11. If parents and young people respond to the information, and the message to get vaccinated, we could stop it in its tracks, says Bedford.

Vaccination rates are lowest in London, where just 74% of children have received two doses of the vaccine. Two doses are 97% effective against catching measles. One local council in the capital has launched a vaccine-awareness campaign in multiple languages to reach more people.

Without further action, the outbreak could spread more widely across the United Kingdom, causing deaths, says Bedford.

In 2018, a measles outbreak of around 900 cases occurred in England. The previous year, the WHO had declared that the United Kingdom had eliminated the disease, defined as the absence of circulating measles. Despite losing the elimination status, the country gained it again in 2021.

In response to the outbreak, Public Health England, the UKHSAs predecessor, advised people to get the MMR vaccine. The only thing that you can do to stop measles spreading is get vaccinated, says Bedford. This means catching up people who didnt have it, including those who didnt have it 20 years ago, she says.

Since 1 December, there have been 23 confirmed measles cases in the United States, across Georgia, Missouri, New Jersey and Pennsylvania. Many of the cases were linked to international travellers returning to the country, and reflect a rise in the number of measles cases globally, according to a newsletter sent by the US Centers for Disease and Control and Prevention on 25 January. There were 58 reported US cases last year, down from 121 in 2022. This is much less than the more than 1,200 US infections in 2019.

But Europe is facing a more alarming situation. There was a 45-fold rise in measles cases in the WHOs European region from 2022 to 2023. In 2023, the regions 40 member states reported some 42,200 measles cases, up from fewer than 1,000 in 2022.

The rise in cases is also the result of declining national vaccination rates, which fell from 92%, on average, in 2019 to 91% in 2022, according to the WHO.

Globally, the number of measles cases increased by 18% between 2021 and 2022, and deaths from measles increased by 43%, according to a WHO report released last November.

This article is reproduced with permission and was first published on January 31, 2024.

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An Alarming Rise in Measles Cases Is Being Driven By Low Vaccination Rates - Scientific American

Newest COVID shots are 54% effective in preventing symptoms, CDC finds – ABC News

February 2, 2024

The latest COVID-19 vaccines are 54% effective at preventing symptomatic infection in adults

By

MIKE STOBBE AP Medical Writer

February 1, 2024, 1:01 PM ET

2 min read

NEW YORK -- The latest versions of COVID-19 vaccines were 54% effective at preventing symptomatic infection in adults, according to the first U.S. study to assess how well the shots work.

The shots became available last year and were designed to better protect against more recent coronavirus variants.

In Thursday's study, the Centers for Disease Control and Prevention looked at 9,000 people who got tested for COVID-19 at CVS and Walgreens pharmacies, checking who tested positive and whether they had gotten a new shot or not.

The 54% finding is similar to what's been reported in other countries, and it's also about what was reported for an earlier vaccine version, said the Ruth Link-Gelles of the CDC, the study's lead author.

Studies coming out later this year will assess how effective the shot was at preventing symptoms severe enough to send patients to a doctor's office or hospital, she said.

The CDC recommends the new shots for everyone 6 months and older, but most Americans haven't gotten them. The latest CDC data suggests only about 22% of U.S. adults have gotten the shots, and only 11% of children. The slow uptake meant that it took longer for researchers to gather enough data to assess how well the shots work, Link-Gelles said.

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Newest COVID shots are 54% effective in preventing symptoms, CDC finds - ABC News

Here’s How Effective the Latest COVID-19 Shots Are for Adults – Medpage Today

February 2, 2024

The updated 2023-2024 COVID-19 vaccine was approximately 54% effective against symptomatic SARS-CoV-2 infection in adults, and was also effective against the JN.1 variant, which became predominant in January, CDC researchers said.

Overall, vaccine effectiveness against symptomatic COVID was 57% for people ages 18 to 49 years and 46% for people ages 50 and older, reported Ruth Link-Gelles, PhD, of the CDC's National Center for Immunization and Respiratory Diseases, and colleagues in the Morbidity and Mortality Weekly Report.

The updated vaccine is a monovalent XBB.1.5-derived vaccine, and there have been few estimates regarding its effectiveness, the authors noted. This study is the first to look at the vaccine's effectiveness against symptomatic COVID caused by the JN.1 variant, a derivative of BA.2.86.

The data came from the CDC's Increasing Community Access to Testing program that provided no-cost SARS-CoV-2 nucleic acid amplification tests (NAAT) to uninsured people at participating CVS and Walgreens pharmacies from Sept. 21, 2023 to Jan. 14, 2024.

Vaccine effectiveness was 58% among those who received testing 7 to 59 days after receiving the updated vaccine, and 49% among those who received testing 60 to 119 days after receipt.

In a subanalysis, the researchers also looked at spike gene amplification results from reverse transcription-polymerase chain reaction (RT-PCR) COVID tests to differentiate XBB lineages from JN.1 and other Omicron BA.2.86 lineages.

For those who had received the updated vaccine 60 to 119 days earlier, vaccine effectiveness was 49% for tests indicating infection with JN.1 lineages, and 60% for tests indicating infection with non-JN.1 lineages.

"Whereas the goal of the U.S. COVID-19 vaccination program is to prevent severe disease, vaccine effectiveness against symptomatic infection can provide useful insights into protection early after introduction of updated vaccines and during the emergence of new lineages," Link-Gelles and colleagues wrote.

The study only looked at data through 119 days since vaccination -- a relatively brief period of time, the authors pointed out. "Waning of effectiveness is expected with additional elapsed time since vaccination, especially against less severe disease," they noted.

In September 2023, the CDC's Advisory Committee on Immunization Practices (ACIP) recommended that everyone 6 months of age and older get the 2023-2024 updated COVID vaccine.

This analysis looked at 9,222 NAAT COVID test results over the study period among people with COVID-like symptoms. Most people tested were women (61%), about 40% were white, 30% were Hispanic or Latino, and 16% were Black or African American.

Of available NAAT tests, 36% were positive for SARS-CoV-2. The researchers calculated vaccine effectiveness by comparing odds of receipt versus nonreceipt of the updated COVID vaccine among those who tested positive (case patients) and those who tested negative (control patients). Of the 1,125 individuals who had received an updated COVID vaccine at least 7 days before testing, 14% were SARS-CoV-2-negative and 9% were positive.

Notably, only 12% of all people tested reported that they had received an updated vaccine dose, and over 26% had never received any COVID vaccine. Sixty percent reported a previous SARS-CoV-2 infection more than 3 months before the current test.

Link-Gelles and team pointed out that vaccination status, previous infection history, and underlying medical conditions were self-reported and subject to bias. Since there is a high prevalence of infection-induced SARS-CoV-2 immunity among adults in the U.S., previous infection was probably underreported and likely provided some protection against repeat infection.

Katherine Kahn is a staff writer at MedPage Today, covering the infectious diseases beat. She has been a medical writer for over 15 years.

Disclosures

Link-Gelles and co-authors reported no potential conflicts of interest.

Primary Source

Morbidity and Mortality Weekly Report

Source Reference: Link-Gelles R, et al "Early estimates of updated 2023-2024 (monovalent XBB.1.5) COVID-19 vaccine effectiveness against symptomatic SARS-CoV-2 infection attributable to co-circulating Omicron variants among immunocompetent adults -- Increasing Community Access to Testing program, United States, September 2023-January 2024" MMWR 2024; DOI: 10.15585/mmwr.mm7304a2.

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Here's How Effective the Latest COVID-19 Shots Are for Adults - Medpage Today

Los Angeles County has its first measles case since 2020 – Los Angeles Times

February 2, 2024

A recently arrived traveler at Los Angeles International Airport is the source of the first case of measles in L.A. County since 2020.

Measles is a highly infectious disease, and health experts say the best way to evade infection is immunization.

The Los Angeles resident was a passenger on a Turkish Airlines flight that arrived at 5 p.m. Jan. 25 at the Tom Bradley International Terminal, Gate 157. Anyone who was at Terminal B from 5 to 9 p.m. may have been exposed and could be at risk of developing measles.

L.A. public health officials are notifying Turkish Airlines passengers who sat close to this flier about possible measles exposure.

The measles virus can live in the air for up to two hours after an infected person has left the area, according to the U.S. Centers for Disease Control and Prevention, which works with the L.A. Department of Public Health to investigate communicable disease exposure on international flights to the U.S.

Following the flight, the infected person made a stop at a Northridge Chick-fil-A.

Patrons who were at the restaurant at 18521 Devonshire St. between 8 and 10:30 p.m. may be at risk of developing measles, county health officials said.

Additional locations where possible exposures may have occurred are being investigated by the health department.

Measles is spread by air and by direct contact, said Muntu Davis, Los Angeles County health officer, in a news release. Even before you know it, you have it, and [it] can lead to severe disease.

Those who havent been immunized against measles, or are not sure whether theyve had the vaccine, and were at these sites during the date and times listed above are at risk of developing measles. Symptoms appear from seven to 21 days after exposure to the virus. Those who have been free of symptoms for more than 21 days are no longer at risk.

The CDC reported a recent rise in domestic measles cases. Between Dec. 1 and Jan. 23, the agency was notified of 23 confirmed U.S. cases of measles, including seven direct importations of measles by international travelers and two outbreaks with more than five cases each.

Public health officials recommend:

Last month, the CDC released an alert for healthcare providers for measles cases after there were 23 confirmed cases throughout the U.S.

The best way to prevent measles infection is by getting the MMR vaccine, which covers measles, mumps and rubella. Children need two vaccine doses, one when they are 12 to 15 months old and the second between the ages of 4 and 6. Teenagers and adults who have not yet been immunized need one dose.

The virus is highly contagious and lives in the nose and throat mucus of an infected person, according to the CDC. It can spread through coughing and sneezing.

The CDC says the virus is so contagious that if one person has it, up to 90% of the people who are not immune and are in close proximity to that person will also become infected.

Measles can also spread when other people breathe the contaminated air or touch an infected surface, then touch their eyes, nose or mouth.

The infection can be spread four days before symptoms begin or four days after signs of the virus.

The first symptoms of measles infection will appear in seven to 14 days of contracting the infection.

We know measles as a rash on the skin, but it can be dangerous especially for babies and young children. Measles typically begins with high fever (which could spike to more than 104 degrees), cough, runny nose and red, watery eyes.

Two to three days after symptoms begin, tiny white spots may appear inside the mouth.

In three to five days after having symptoms of measles infection, a rash breaks out. It usually begins as flat red spots that appear on the face and at the hairline, then spreads downward to the back, trunk, arms, legs and feet.

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Los Angeles County has its first measles case since 2020 - Los Angeles Times

Opinion | The Monster Measles Outbreak in Europe Is a Warning – The New York Times

February 2, 2024

In 2022, there were 941 reported cases of measles in the World Health Organizations European region. Over just the first 10 months of last year, according to an alarming bulletin the W.H.O. issued in mid-December, there were more than 30,000.

This is the kind of spike a 3,000 percent increase that looks implausible in headlines. And it appears even more significant compared to recent years, when efforts to limit Covid also resulted in almost entirely eliminating measles in Europe in 2021. (In a lot of places, we sort of accidentally eliminated the spread of flu, too.)

But as the year drew to a close, the European measles outbreak kept growing. Through December, case numbers in the region eventually reached over 42,000, and although the largest outbreaks were in countries most Americans regard as pretty remote (Kazakhstan, Kyrgyzstan and Russia), there is also a vicious surge in Britain, which may look plausibly to us as the canary in a coal mine. There, in just one of Englands nine regions, the West Midlands, 260 cases have been confirmed and dozens more suspected, in a country which, as a whole, recorded just two cases as recently as 2021.

Almost certainly, the virologist Rik de Swart of Erasmus University Medical Center in Rotterdam told me, these official case totals are significant underestimates. But as intimidatingly large as they are, the outbreaks are not in any way surprising to infectious disease specialists, who have been warning that long-term declines in vaccination rates were creating the possibility of a huge resurgence. This is precisely what is expected, the epidemiologist Michael Mina, formerly of Harvard, told me. The epidemiologist Bill Hanage, also at Harvard, lamented it as a chronicle of an outbreak foretold.

There have been worrying outbreaks, too, in the United States, where the occurrence of a few dozen cases nationwide is sufficient to command federal public health attention. But it is striking especially given pandemic panic about Americas exceptional-seeming resistance to vaccination that the worlds highest-profile post-Covid measles surge has come not here but in Europe.

Almost since the beginning of the pandemic, public health officials worried that efforts to limit transmission of Covid could interrupt vaccination programs for other diseases, particularly in the developing world, and almost since the start of Covid-19 vaccination programs, theyve worried that rising vaccine skepticism, particularly in the United States, might permanently damage acceptance of previously routine vaccines for measles, mumps and rubella, for instance.

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Opinion | The Monster Measles Outbreak in Europe Is a Warning - The New York Times

Poonam Pandey dies of cervical cancer: By what age should women get HPV vaccine – IndiaTimes

February 2, 2024

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As per a shocking post on her official instagram account , Actor and model Poonam Pandey passed away at 32 on Thursday night. The actor died of cervical cancer. Many were surprised by the news, and some began to look for the cause of the death and gain awareness about cervical cancer. If youve been wondering about this deadly form of cancer, heres all you need to know about it.

Cancer that originates in the cervix's cells is known as cervical cancer. The narrower, lower end of the uterus is called the cervix (womb). Cervical cancer is a significant health concern, and it is primarily caused by the HPV virus, which is sexually transmitted. Factors such as early age sexual activity, unprotected sex, and tobacco/alcohol consumption can further increase the risk of developing cervical cancer.

One of the key challenges is the lack of awareness among women. Many women do not opt for Pap smear testing, which is an essential part of the overall health checkup for women of reproductive age, recommended every 1 to 3 years. However, a sexually active patient should undergo opportunistic screening, including Pap smear testing. Increasing awareness is crucial in addressing this issue.

Dr. Thejaswini J, Consultant Obstetrician and Gynaecologist, Motherhood Hospitals, E-city, Bengaluru, The most common age group for cervical cancer is between 30 and 45 years, but in rare incidence it can still be found in women younger than that. However, over the years, the incidence of cervical cancer has reduced due to preventive testing and improved detection rates. Protective sexual practices, HPV vaccination, regular Pap smears once sexually active, and consistent preventive health checks are essential preventive measures.

The cervical cancer vaccine is designed to prevent cervical cancer in females and penile cancer in males. It is crucial to administer the vaccine after the age of 12 for both genders and can be taken till the age of 45. For optimal effectiveness, it is highly recommended to receive the vaccine before initiating any sexual activity.

All women must make their health a priority and schedule regular screenings to protect themselves against cervical cancer. Early detection through screenings can significantly increase the chances of successful treatment and improved outcomes.

Also Read: Cervical cancer: What you need to know about this silent killer

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Poonam Pandey dies of cervical cancer: By what age should women get HPV vaccine - IndiaTimes

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