From Our Bureau    

15TH JUNE 2020

The Corona Virus (COVID-19) pandemic situation remained grim globally, with the confirmed cases across the world soaring to 78,23,289 and the death toll reaching 4,31,541 in the 216 affected countries and territories, according to the latest update from the World Health Organization (WHO).

Globally, American region continued to be the worst-hit with 37,81,538 confirmed cases and 2,01,848 deaths. Europe came next with 24,16,920 confirmed cases and 1,88,350 deaths. Eastern Mediterranean region reported 7,78,200 confirmed cases and 17,077 deaths.

South-East Asia region’s tally stood at 4,71,392 confirmed cases and 12,927 deaths. Western Pacific region recorded 1,98,995 confirmed cases and 7,215 deaths and African region registered 1,75,503 confirmed cases and 4,111 deaths. WHO Risk Assessment at global level remained very high.

As the pandemic accelerates in low- and middle-income countries, WHO is especially concerned about its impact on people who already struggle to access health services – often women, children and adolescents. WHO has developed guidance on maintaining essential services.

WHO has also carefully investigated the risks of women transmitting COVID-19 to their babies during breastfeeding. Based on the available evidence, WHO’s advice is that the benefits of breastfeeding outweigh any potential risks of transmission of COVID-19. A Q and A on breastfeeding and COVID-19 is also available.

WHO has recently released a photo story outlining ten actions you can take to protect and improve your sexual and reproductive health during the COVID-19 pandemic. At present, there is no evidence of sexual transmission of the virus responsible for COVID-19. The virus can be passed however, through direct contact with saliva, for instance, kissing.

There are also many things people can do to take care of their own health, like staying active, eating a nutritious diet and limiting their alcohol intake.

In today’s Subject in Focus, WHO takes a look at the Solidarity Trials, which are being used to accelerate research on a COVID-19 Vaccine.

Subject in Focus: Accelerating research on a COVID-19 Vaccine

Since the start of the pandemic, there has been an urgent need to accelerate the research and development of a safe and effective vaccine.

To facilitate research and vaccine development, WHO’s R&D Blueprint team convened:

1. A process to develop a core clinical trial study protocol for a global, and globally coordinated, clinical trial for vaccines. The idea is to accelerate research on COVID-19 vaccines through a large, international, randomized controlled clinical trial using a standardized study protocol that enables the agile, simultaneous evaluation of the benefits and risks of multiple candidate vaccines in sites with sufficient COVID-19 attack rates.

To date, more than 120 different candidate vaccines are under development and could be available or suitable to enter the trial at different times. The aim of the Solidarity Trial is to quickly enrol and individually randomize very large numbers of adult participants in many different populations and settings across the world. By using a shared placebo/control group and a common core study protocol to evaluate multiple candidate vaccines in the trial, resources allocated to the evaluation of each candidate vaccine can be saved while ensuring a high standard of scientific rigor and efficiency.

Following an in-depth review by experts and various consultations, a revised version of the WHO core protocol was recently published. In addition, WHO has also launched a call for expressions of interest from vaccine trial sites around the world to identify those that would participate in a vaccine Solidarity Trial using this core protocol.

2. A multi-disciplinary group of experts from across the world to discuss, from different perspectives, to develop the concept of Human Challenge Studies. The WHO Advisory Group for “Human Challenges” was tasked with considering the feasibility, potential value and limitations of establishing a closely monitored human challenge model of experimental COVID-19 infection and illness in healthy young adult volunteers.

This Advisory Group included experts with experience in:

• design and performance of many types of volunteer challenge studies,

• SARS-CoV-2 virology,

• measurement of human immune responses to SARS-CoV-2 and to other microbial pathogens,

• clinical management of COVID-19 clinical disease in different geographic settings,

• regulatory considerations associated with testing and emergency pre-licensure use of vaccines and with larger-scale post-licensure deployment,

• and GMP manufacture of virulent viruses under BSL-3 containment.

The Working Group was sub-divided into four subgroups to address: Clinical Trials Issues, Challenge Virus Strain Issues, Measurement of Immune Responses Pre- and Post-Challenge, and Detection of SARS-CoV-2 in Clinical Specimens Post-challenge.

Since its constitution, the Advisory Group has convened several times to deliberate on this question and to make recommendations. A full report of this Advisory Group will be available shortly on the R&D Blueprint and COVID-19 webpage. This complements the 6 May 2020 document outlining the key criteria for the ethical acceptability of Covid-19 human challenge studies.

At the media briefing on 15th June, WHO Director-General Dr Tedros Adhanom Ghebreyesus said, “Globally, more than 7.8 million cases of COVID-19 have now been reported to WHO, and more than 430,000 deaths. It took more than 2 months for the first 100,000 cases to be reported.”

“For the past two weeks, more than 100,000 new cases have been reported almost every single day. Almost 75 percent of recent cases come from 10 countries, mostly in the Americas and South Asia. However, we also see increasing numbers of cases in Africa, Eastern Europe, Central Asia and the Middle East,” he added.

“Even in countries that have demonstrated the ability to suppress transmission, countries must stay alert to the possibility of resurgence. Last week, China reported a new cluster of cases in Beijing, after more than 50 days without a case in that city. More than 100 cases have now been confirmed. The origin and extent of the outbreak are being investigated,” he observed.

“Despite the ongoing global response to the COVID-19 pandemic, we cannot lose sight of other significant public health issues, including influenza. Influenza affects every country every year, and takes its own deadly toll. As we enter the southern hemisphere influenza season and begin planning for the northern hemisphere season, we must ensure that influenza remains a top priority.

“Co-circulation of COVID-19 and influenza can worsen the impact on health care systems that are already overwhelmed. More than 500 million people are vaccinated against flu every year, based on recommendations from WHO on the composition of flu vaccines. These recommendations are based on data and virus samples collected and analyzed by WHO’s Global Influenza Surveillance and Response System, or GISRS. 

“The GISRS system has been functioning since 1952 and I would like to thank the more than 125 countries that participate in it. Over the past 8 years, significant strengthening of the system has been made possible through the Pandemic Influenza Preparedness Framework, and I would also like to thank the public and private sector partners that participate in this global system.

“The infrastructure, people, skills and experience built up through GISRS, WHO Collaborating Centres, and national influenza centres have been the foundation for detecting COVID-19. However, this well-established system is now seeing significant challenges. Influenza surveillance has either been suspended or is declining in many countries, and there has been a sharp decline in sharing of influenza information and viruses because of the COVID-19 pandemic.

“Compared with the last three years, we’ve seen a dramatic decrease in the number of specimens tested for influenza globally. We’ve also seen a 62% decrease in the number of virus shipments to WHO Collaborating Centres, and a 94% decrease in the number of influenza viruses with genetic sequence data uploaded to the GISAID database.

“These decreases are due to a combination of issues, including the repurposing of staff and supplies, overburdened laboratories, and transport restrictions. These disruptions may have short- and long-term effects, such as the loss of capacities to detect and report new influenza viruses with pandemic potential.

“As many of you know, twice a year WHO convenes a group of experts who together analyze the circulating flu strains. Based on their analysis they select the viruses that should be targeted by flu vaccines for the upcoming season in each hemisphere. To know which viruses are circulating, WHO relies on information from countries reported through GISRS, which we use to make recommendations for the composition of influenza vaccines. This will help us to prevent more severe cases of flu and more deaths.

“WHO has published guidance on how to integrate surveillance for COVID-19 into routine influenza surveillance as an efficient way to track both of these important respiratory viruses. This is not only cost-effective, it’s also essential for protecting the world against the next flu season. The Southern Hemisphere flu season is already underway. There is no time to lose,”  the WHO Director-General added. (eom)

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