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Europe accelerates review for Pfizer-BioNTech’s COVID-19 vaccine; S’pore expects delivery of first shots by December-end

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4 years ago

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The European Medicines Agency (EMA) said on Tuesday (15 December) that its Human Medicines Committee (CHMP) has brought forward meeting for Pfizer-BioNTech COVID-19 vaccine to 21 December, more than a week ahead of its initial date 29 December, after mounting pressure from the public.

EMA said in a statement that the meeting planned for 29 December will be maintained, should it be needed.

“Following receipt yesterday evening of additional data requested by the CHMP from the company and pending the outcome of its evaluation, an exceptional meeting of the CHMP has now been scheduled for 21 December to conclude if possible,” it stated.

In the past weeks, the CHMP has been working with experts to evaluate data submitted by BioNTech and Pfizer in the context of the conditional marketing authorisation application for BNT162b2 vaccine, said EMA.

“The rate of progress is reliant on a robust and complete assessment of the quality, safety and efficacy and is determined by availability of additional information from the company to respond to questions raised during the evaluation,” it added.

EMA assured that the European Commmission will “fast track” their decision-making process to grant a marketing authorisation valid in all European Union and European Economic Area member states “within days” once the CHMP has given its approval.

“The CHMP will conclude its assessment at the earliest possible timepoint and only once the data on the quality, safety and effectiveness of the vaccine are sufficiently robust and complete to determine whether the vaccine’s benefits outweigh its risks,” it asserted.

The authorisation will carry all the safeguards, including a risk-management and safety monitoring plan, conditions for storage and other manufacturing controls, an investigation plan for use in children and a framework for evaluation of emerging efficacy and safety data, said EMA.

“A marketing authorisation ensures that COVID-19 vaccines meet the same high EU standards as for all vaccines and medicines,” it noted.

The Pfizer-BioNTech vaccine has already received conditional approvals or emergency authorisations from four regulatory agencies, including the UK’s Medicines and Healthcare products Agency (MHRA), Health Canada, the US’ Food and Drug Administration (FDA), and Singapore’s Health Sciences Authority (HSA).

S’pore approves Pfizer-BioNTech’s COVID-19 vaccine

Over in Singapore, the HSA has recently granted an authorisation for the Pfizer-BioNTech COVID-19 vaccine to be used in the city-state, despite having lack of efficacy and safety data on some groups of people – pregnant women, people with compromised immune systems and those under the age of 16.

Prime Minister Lee Hsien Loong announced on Monday (14 December) that the agency has approved the COVID-19 vaccine, with the first shipment due to arrive in Singapore by the end of December.

In a statement, HSA claimed the data submitted by Pfizer and BioNTech on its vaccine was “robustly and thoroughly reviewed” by Singapore regulators, adding that international scientific standards were applied during the evaluation.

“HSA’s review of the available clinical data found that the benefits of the Pfizer-BioNTech COVID-19 vaccine outweigh the known risks. The vaccine demonstrated a high vaccine efficacy of 95%,” it stated.

The vaccine was granted interim authorisation under the Pandemic Special Access Route (PSAR), which facilitates access to critical novel vaccines, medicines and medical devices during a pandemic, said HSA.

“Using PSAR, HSA can start evaluating new vaccines, medicines and medical devices from the early stages of clinical studies, as and when real-time data is submitted by companies on a ‘rolling’, or staggered basis, instead of waiting for the full data set to be submitted before starting our evaluation,” it added.

Citing the vaccination regime submitted by Pfizer-BioNTech, HSA said two doses are required to be administered 21 days apart, in people aged 16 years and above.

“Pregnant women, immunocompromised persons and those under the age of 16 should also not receive the Pfizer-BioNTech vaccine as the safety and efficacy data on this group of persons is not available yet,” it said.

Additionally, people with a history of anaphylaxis or the rapid onset of severe allergic reactions should not receive the Pfizer-BioNTech vaccine as a precautionary measure.

Noting that the safety profile of the vaccine is “generally consistent” with other registered vaccines, HSA explained that some people may experience side effects such as pain, redness, swelling at the injection site, as well as fatigue, headache and muscle ache after vaccination.

While not everyone will experience these side effects, they are “common and expected” as part of the body’s natural response to build immunity against the COVID-19, it further noted.

“As a condition for the interim authorisation under PSAR, Pfizer and BioNTech are required to monitor the longer term efficacy of the vaccine to determine the duration of protection against COVID-19.

“This will augment the available data which shows that the vaccine continues to be effective for at least 2 months, with no signs of waning protection,” said HSA.

Pfizer and BioNTech are also required to continue to follow up on the safety of the vaccine for a longer period of time to determine its full safety profile.

“The companies must continue submitting the longer term follow up data to HSA to assure the continued effectiveness and safety of the vaccine. HSA will actively review the data to ensure that the benefits of the vaccine continue to outweigh the known risks,” said the agency.

Responding to a query about when the first vaccine shots would be given, the Ministry of Health (MOH) director of medical services Kenneth Mak said it would be more important to ensure that the vaccines are safely delivered and administered properly.

“We’re not fussed about whether or not there’s a period of time that passes between the vaccines arriving in Singapore and the first vaccinations starting, but we do want to make sure that we’re able to do this safely to our at-risk populations in Singapore in a timely fashion,” he told Yahoo News Singapore.

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Survey reveals one-third of Singaporean youth struggle with severe mental health issues

A national study by the Institute of Mental Health reveals that 30.6% of Singaporean youth suffer from severe symptoms of depression, anxiety, or stress, driven by factors like excessive social media use, body image concerns, and cyberbullying. The findings emphasize the need for early intervention and targeted mental health strategies.

Published

3 weeks ago

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23 September 2024

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A significant portion of Singapore’s youth are experiencing severe mental health challenges, according to a comprehensive national survey conducted by the Institute of Mental Health (IMH).

The National Youth Mental Health Study (NYMHS), released on 19 September 2023, found that 30.6% of individuals aged 15 to 35 reported severe or extremely severe symptoms of depression, anxiety, or stress, with key risk factors including excessive social media use, body shape concerns, and experiences of cyberbullying.

The study, which surveyed 2,600 Singaporean citizens and permanent residents, highlights the growing mental health concerns among Singaporean youth and suggests the need for more targeted interventions and support systems.

Mental Health Issues Prevalent Among Youth

Anxiety was the most common mental health issue, with 27% of respondents reporting severe or extremely severe symptoms, followed by depression (14.9%) and stress (12.9%).

These findings underscore the high prevalence of mental health issues among young people, particularly in those aged 15 to 24, who were more likely to report severe symptoms compared to older participants.

According to the IMH, young people who were female, single, unemployed, or had lower levels of education or household income were more prone to severe mental health symptoms.

For example, youth with monthly household incomes below S$5,000 were more likely to experience severe anxiety​.

Key Risk Factors: Social Media, Body Image, and Cyberbullying

The study identified three major factors linked to severe mental health symptoms:

  1. Excessive Social Media Use: Around 27% of respondents reported using social media for more than three hours daily, which was associated with a significantly higher likelihood of severe mental health issues. Youth with excessive social media use were 1.5 to 1.6 times more likely to experience severe symptoms of depression, anxiety, or stress​.
  2. Body Shape Concerns: About 20.2% of youth had moderate to severe concerns about their body image. These individuals were 4.9 times more likely to experience severe depression, 4.3 times more likely to experience severe anxiety, and 4.5 times more likely to suffer from severe stress​. Such concerns were often linked to social media exposure, which can perpetuate unrealistic beauty standards and increase dissatisfaction with one’s body.
  3. Cyberbullying: One in five youth (21%) reported being victims of cyberbullying. These individuals were approximately twice as likely to report severe mental health symptoms compared to those who had not experienced such harassment​. The anonymity and pervasive nature of online bullying exacerbates the mental health toll on young people, according to the study.

Demographics at Higher Risk

The study found that specific demographics were more vulnerable to mental health issues. Young people aged 15 to 24 were more likely to experience anxiety, depression, and stress, particularly females, those who were single, and those with lower levels of education, such as junior college or vocational qualifications​.

The Malay ethnic group was also found to have a higher prevalence of severe mental health symptoms compared to other ethnic groups​.

Barriers to Seeking Help and Sources of Support

Although about 69.1% of those with severe mental health symptoms sought help—primarily from family and friends—a significant portion of young people hesitated to seek professional support.

The top reasons included concerns about privacy, fear of judgment, and doubts about the effectiveness of professional services​.

Among those who sought help, family and friends were the most common sources of support (57.9%), followed by self-help measures (31.1%) and medical services (20.1%)​.

However, the reluctance to seek professional help highlights the need for continued efforts to destigmatize mental health treatment and increase awareness of available services.

Protective Factors: Resilience, Social Support, and Self-Esteem

The study also identified factors that helped mitigate mental health challenges. Youth who reported higher levels of resilience, perceived social support, and self-esteem were significantly less likely to experience severe symptoms of depression, anxiety, or stress.

This suggests that fostering strong support networks and building resilience in youth could play a critical role in improving their mental well-being​.

Government Response and Preventive Measures

The findings of the NYMHS support Singapore’s broader National Mental Health and Well-Being Strategy, launched in October 2023, which adopts a whole-of-government and whole-of-society approach to addressing mental health concerns. Schools have already begun integrating mental health education into their curricula, equipping students with the knowledge and skills to manage their well-being.

Additionally, the government introduced the Parenting for Wellness toolbox in September 2023 to help parents manage their children’s screen time and promote healthy social media usage.

A guide on responsible social media use, expected to be released by mid-2025, will offer further strategies to mitigate the negative impacts of excessive screen time and online harassment​.

Future Implications and Policy Development

Associate Professor Swapna Verma, chairman of IMH’s medical board and co-principal investigator of the study, emphasized the importance of early intervention.

“Not all individuals with severe or extremely severe symptoms of depression or anxiety have a clinical condition, but being in such states for a prolonged period of time can be detrimental to their well-being,” she said​.

The study’s data will help policymakers and healthcare providers develop more targeted approaches to address the mental health needs of Singapore’s youth, especially those most at risk.

Associate Professor Mythily Subramaniam, IMH’s assistant chairman of medical board (research), stressed the need to pay attention to issues like excessive social media use and cyberbullying, noting their “tremendous impact on youth mental health” and the importance of preventive measures​.

Support for Youth Facing Mental Health Challenges

Young people dealing with mental health challenges in Singapore have access to various resources:

  • CHAT (Centre of Excellence for Youth Mental Health): CHAT offers a safe and confidential space for youth to seek help through online and face-to-face mental health assessments and support.
  • Institute of Mental Health (IMH): IMH provides a comprehensive range of mental health services, including outpatient consultations and inpatient care. Youth in crisis can also seek immediate assistance from the 24-hour Mental Health Helpline at 6389 2222.
  • Samaritans of Singapore (SOS): SOS offers emotional support for those feeling distressed or experiencing suicidal thoughts. Their 24-hour hotline is 1767.
  • Health Promotion Board’s National Care Hotline: This hotline provides immediate emotional support for those in need and can be reached at 1800-202-6868.
  • Counselling Services: School-based counsellors, as well as community-based services such as TOUCH Youth, provide further avenues of support for young people grappling with mental health issues.
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Health

Malaysia reports new mpox case in man without recent international travel

Malaysia has confirmed its first mpox case of 2024 in a male patient, the Health Ministry reported. The patient is in isolation and stable, with authorities monitoring his contacts. This brings the total confirmed cases since July 2023 to ten, all from clade II.

Published

4 weeks ago

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17 September 2024

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MALAYSIA: The Malaysian Health Ministry confirmed a new case of monkeypox (mpox) in a male citizen, marking the country’s first confirmed case of 2024.

The patient, who began showing symptoms on 11 September, is currently in isolation and in stable condition.

The ministry, in a statement issued Tuesday (17 September), revealed that the patient first experienced fever, sore throat, and cough, followed by the appearance of rashes on 12 September.

He has no recent history of international travel within the past 21 days, and authorities are in the process of identifying and monitoring his close contacts, following strict standard operating procedures (SOPs).

“Out of the 58 suspected mpox cases referred to the ministry this year, one case has been confirmed positive for mpox clade II as of 16 September,” the ministry stated.

“All 10 cases reported in Malaysia since July 2023 have been from clade II.”

The Health Ministry had earlier reported that Malaysia recorded a total of nine mpox cases since the first detection on 26 July 2023, with the most recent case reported in November 2023.

All previous cases had links to high-risk activities, but no deaths were reported.

Global Context and National Preparedness

Mpox was declared a Public Health Emergency of International Concern (PHEIC) for the second time on 14 August this year, due to the rapid spread of the clade Ib variant, particularly from the Democratic Republic of Congo (DRC) and neighboring African nations.

In response, Malaysia’s Health Ministry activated its national crisis response centre on 16 August to enhance readiness and coordinate preventive measures.

The ministry advised the public to take precautions, including maintaining personal hygiene and avoiding direct contact with individuals suspected or confirmed to be infected with mpox.

High-risk individuals experiencing symptoms such as fever, swollen lymph nodes, and rashes are urged to seek immediate medical attention.

Mpox is caused by the monkeypox virus (MPVX) and spreads through close contact with symptomatic individuals.

The incubation period is typically between 5 and 21 days, and patients remain contagious until all lesions have dried up and fallen off.

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