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The European Medicine Agency (EMA) announced on July 9, 2021, it had concluded that myocarditis and pericarditis could occur in very rare cases following vaccination with the mRNA COVID-19 vaccines Comirnaty (Pfizer-BioNTech) and Spikevax (Moderna).
The EMA's Committee concluded that the cases primarily occurred within 14 days after vaccination, more often after the second dose, and in younger adult men.
At this point in time, the EMA says there is no causal relationship with heart disease and the other COVID-19 vaccines Authorized in Europe, COVID-19 Vaccine Janssen and Vaxzevria,
Therefore, the EMA's vaccine committee recommends listing myocarditis and pericarditis as new side effects in the product information for these vaccines. As of May 2021, around 177 million doses of Comirnaty and 20 million doses of Spikevax had been given in Europe.
Furthermore, the EMA is raising this health risk awareness among healthcare professionals and people taking these vaccines. Myocarditis and pericarditis are heart inflammatory conditions. Symptoms can vary but often include breathlessness, a forceful heartbeat that may be irregular, and chest pain.
In reaching its conclusion, the Committee took into consideration all currently available evidence.
The EMA's analysis included an in-depth review of 145 cases of myocarditis in the European Economic Area (EEA) among people who received Comirnaty and 19 cases among people who received Spikevax. The committee also reviewed reports of 138 cases of pericarditis following the use of Comirnaty and 19 cases following the Spikevax vaccination.
Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. Furthermore, they should consult applicable guidance and/or consult specialists (e.g., cardiologists) to diagnose and treat these conditions.
The 'EMA confirms that the benefits of all authorized COVID-19 vaccines continue to outweigh their risks, given the risk of COVID-19 illness and related complications. In addition, as scientific evidence shows, they reduce deaths and hospitalizations due to COVID-19.'
'As for all vaccines, the EMA will continue to monitor the vaccines’ safety and effectiveness and provide the public with the latest information, particularly as more adolescents and young adults are vaccinated and more second doses are given.'
This vaccine review was carried out by EMA's Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines. The PRAC’s recommendations will be submitted to EMA’s human medicine committee for endorsement.
Note: The United Kingdom Medicines & Healthcare Regulatory Agency announced similar concerns on July 9, 2021.
Data from nine cities in Mexico confirms that identifying dengue fever “hot spots” can provide a predictive map for future outbreaks of Zika and chikungunya, the Aedes aegypti mosquito spreads viral diseases.
The journal Lancet Planetary Health published the research encompassing data for 2008 through 2020 from Acapulco, Merida, Veracruz, Cancun, Tapachula, Villahermosa, Campeche, Iguala and Coatzacoalcos.
The results found a 6% overlap of hot spots for dengue and Zika and a 53% overlap for dengue and chikungunya cases.
Led by Gonzalo Vazquez-Prokopec, associate professor in Emory University’s Department of Environmental Sciences, this new study provides a risk-stratification method to more effectively guide the control of diseases spread by Aedes aegypti.
“Our results can help public health officials to do targeted, proactive interventions for emerging Aedes-borne diseases,” Prof. Vazquez-Prokopec stated in a press release issued on July 7, 2021. “We’re providing them with statistical frameworks in the form of maps to guide their actions.”
This new work builds on a previous study of the spatial-temporal overlap of the three diseases, focused on Merida, a city of one million located in the Yucatan Peninsula. That study showed that nearly half of Merida’s dengue cases from 2008 to 2015 were clustered in 27 percent of the city. In addition, these dengue hot spots contained 75 percent of the first chikungunya cases reported during the outbreak of that disease in 2015 and 100 percent of the first Zika cases reported during the Zika outbreak of 2016.
Mosquito control efforts generally involve outdoor spraying that covers broad swaths of a city.
However, Vazquez-Prokopec is currently leading a consortium in a randomized clinical trial in Merida to test targeted indoor residual spraying as an intervention against Aedes-borne diseases. The five-year trial, launched in 2020, is funded by a $6.5 million grant from the US National Institutes of Health.
Data from nine cities in Mexico confirms that identifying dengue fever “hot spots” can provide a predictive map for future outbreaks of Zika and chikungunya. All three of these viral diseases are spread by the Aedes aegypti mosquito.
This study's results found a 62% overlap of hot spots for dengue and Zika and a 53% overlap for cases of dengue and chikungunya.
The journal Lancet Planetary Health published the research on July 7, 2021. This study provides a risk-stratification method to more effectively guide the control of diseases spread by Aedes aegypti.
The work was funded by USAID, the U.S. CDC, the Canadian Institute of Public Health, the state of Yucatan, the National Institutes of Health, and Emory University.
India's Kerala state Health Minister Veena George confirmed on July 10, 2021, that there are currently 14 cases of Zika virus in the state. "Our dept is on high alert and monitoring the situation closely," posted Asian News International on Twitter.
A 24-year-old pregnant woman was found to be infected with the mosquito-borne disease and was undergoing treatment at a hospital in Thiruvananthapuram city.
According to the U.S. CDC, pregnant women are particularly vulnerable. This is because they can transmit the infection to their newborns, resulting in life-altering conditions such as microcephaly, which causes babies to be born with a smaller head due to abnormalities in brain development. Adults can also get Guillain-Barre syndrome.
As of June 29, 2021, the CDC confirmed 12 Zika cases acquired through presumed local mosquito-borne transmission in Puerto Rica during 2021.
Several Zika vaccine candidates are in various stages of a clinical study, but the U.S. FDA has not Apporved any Zika vaccines.
The US Department of State issued a low-level Travel Advisory for the British Virgin Islands on July 7, 2021. The State Department says, 'exercise normal precautions in the British Virgin Islands.'
If you decide to travel to the British Virgin Islands, the State Department suggests enrolling in the Smart Traveler Enrollment Program to receive Alerts and make it easier to locate you in an emergency. And review the Crime and Safety Report for Barbados, which covers the British Virgin Islands.
Furthermore, U.S. citizens who travel abroad should always have a contingency plan for emergencies, such as this Traveler’s Checklist.
Recently, U.S. Ambassador to Barbados Linda Taglialatela met with Governor-General Dame Sandra Mason on July 4, 2021, to convey the best wishes of the American people on the 245th anniversary of their independence and to celebrate the close ties between the United States of America and Barbados.
The US Embassy is located at Wildey Business Park, St. Michael BB 14006, Barbados, W.I. Phone: (246) 227-4000.
Note: The Department of State increased the Travel Advisory Level for the French West Indies on June 16, 2021, which includes the islands of Guadeloupe, Martinique, French Saint Martin, and Saint Barthélemy to a Level 3 – Do Not Travel, due to health and safety measures and COVID-related conditions.
The US Centers for Disease Control and Prevention (CDC) suggested on July 9, 2021; COVID-19 vaccinated teachers and students don’t need to wear masks inside school buildings. And the CDC continues to say 'masks should be worn indoors by all individuals (age 2+) who are not fully vaccinated.'
However, the CDC is not advising schools to require vaccinations for teachers and vaccine-eligible kids.
Nor did the CDC issue advice for people previously infected and recovered from COVID-19.
“We’re at a new point in the COVID-19 pandemic that we’re all really excited about. So it’s time to update the guidance," stated CDR Erin K. Sauber-Schatz, who leads the CDC task force that prepares recommendations designed to keep Americans safe from COVID-19, reported the AP.
Furthermore, the CDC published positive data indicating very few COVID-19 cases in school-age students.
This CDC guidance is meant to supplement—not replace—any federal, state, tribal, local, or territorial privacy or public health and safety laws, rules, and regulations with which K-12 schools must comply.
The Lancet Infectious Diseases published a modeling summary on July 7, 2021, focused on optimal human papillomavirus vaccination (HPV) strategies to prevent cervical cancer in low-income and middle-income countries.
These researchers predicted that HPV vaccination could lead to cervical cancer elimination in Vietnam, India, and Nigeria, but not in Uganda.
Compared with no vaccination, strategies that involved vaccinating girls aged 9–14 years with two HPV vaccine doses were predicted to be the most efficient and cost-effective in all four countries.
The most efficient and cost-effective strategies were routine vaccination of girls aged 14 years, with or without a later switch to routine vaccination of girls aged 9 years, and routine vaccination of girls aged 9 years with a 5-year extended interval between doses and a catch-up program at age 14 years.
Vaccination strategies that included boys or older cohorts of women were substantially less efficient and cost-effective.
Finally, HPV vaccination of girls only and boys and girls with high coverage could eliminate cervical cancer. But In countries like Uganda, adding cervical screening to female or gender-neutral vaccination will likely be required to reach elimination.
Indeed, one of the modes suggested that the addition of twice lifetime HPV screening at ages 35 years and 45 years to HPV vaccination is needed to eliminate cervical cancer in countries with high incidences. The WHO has created the WHO Global Cervical Cancer Elimination Modelling Consortium to identify the most efficient and cost-effective combinations of HPV vaccination, cervical screening, and treatment likely to lead to elimination.
Shanghai-based I-Mab announced today the signing of two new collaborations with emerging biotech companies in China to strengthen its next-generation innovation pipeline. The collaborations with Immorna, an mRNA biotech company, and neoX Biotech, an AI-enabled R&D biotech company, allow I-Mab access to transformative technologies in its quest to discover and develop novel oncology therapeutics.
I-Mab will be developing novel anti-cancer antibody therapeutics through Immorna's pioneering self-replicating mRNA platform.
Moreover, I-Mab will work with neoX Biotech for up to 10 novel biologics programs using neoX's proprietary artificial intelligence algorithm through a strategic collaboration agreement.
Today's announcement is the new addition to the existing collaboration agreements with Complix for cell-penetrating antibody platform and Affinity for masking antibody platform in March 2021, positioning the Company to continually expand its globally competitive pipeline of next-generation antibody assets enabled by transformative technologies.
"Since the launch of our discovery initiative earlier this year, we have identified transformative technologies that can enable us to rapidly expand the emerging portfolio of next-generation novel antibody assets to sustain our innovative immuno-oncology pipeline," said Dr. Taylor Guo, Chief Scientific Officer of I-Mab, in a press statement.
"The immense success of COVID-19 mRNA vaccines exemplifies that mRNA-based drugs have finally established themselves as transformative medicines. And channeling the power of AI into drug discovery holds great promise from unlocking novel targets and modalities to accelerating all aspects of R&D. By embracing these technologies, we have again demonstrated our commitment in executing against our long-term innovation strategy."
I-Mab (Nasdaq: IMAB) is an innovation-driven global biotech company focusing on discovery, development, and soon commercialization of novel and highly differentiated biologics in the immuno-oncology therapeutic area.
The Kingdom of Saudi Arabia will designate a health escort for every 20 pilgrims who will be performing Hajj this year, according to Hesham Saeed, a spokesman for the Saudi Ministry of Hajj and Umrah.
According to local media, these escorts will act as health leaders offering guidance and verify the implementation of precautionary measures during all movements of the pilgrims.”
Saudi Arabia had previously made Covid-19 vaccination mandatory for eligible pilgrims who must be free of chronic diseases.
The Hajj pilgrimage to Islamic holy sites in Mecca, Saudi Arabia, is one of the world’s largest mass gatherings. Hajj will take place July 17-July 22, 2021.
On July 1, 2021, the U.S. CDC recommended that Americans in Saudi Arabia not make the pilgrimage. Mass gatherings, such as Hajj, can increase the risk of getting and spreading COVID-19 because it can be hard to practice physical distancing. In addition, even fully vaccinated people may be at risk for getting and spreading COVID-19 variants.
An updated listing of travel vaccines is published on this webpage.
Sanofi and GSK announced they received approval for their Phase 3 clinical study in India to assess the safety, efficacy, and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate.
The global, randomized, double-blind Phase 3 study will include more than 35,000 volunteers aged 18 and older across sites in the USA, Asia, Africa, and Latin America.
“India is participating in Sanofi Pasteur’s pivotal Phase 3 study, and subject to subsequent approvals, we should soon begin enrollment of study participants in the country,” said Annapurna Das, Country Head, Sanofi Pasteur India, in a press statement issued on July 8, 2021.
In a two-stage approach, the study will initially investigate the efficacy of a vaccine formulation targeting the original virus strain (D.614). At the same time, a second stage will evaluate a second formulation targeting the Beta variant (B.1.351).
Sanofi and GSK will also run clinical studies to assess the ability of the adjuvanted recombinant-protein COVID-19 vaccine candidate to generate a strong booster response regardless of the type of vaccine initially received.
The Phase 3 study initiation follows the global interim Phase 2 results. The adjuvanted recombinant COVID-19 vaccine candidate achieved high neutralizing antibody responses in all adult age groups, with 95 to 100% seroconversion rates. In addition, after a single injection, high neutralizing antibody levels were also generated in participants with evidence of prior SARS-CoV-2 infection, suggesting strong potential for development as a booster vaccine.