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During pregnancy, hormonal levels and immune system function may increase women's vulnerability to viral infections, says the U.S. CDC. Although a SARS-CoV-2 coronavirus infection in pregnant women has been reported mostly asymptomatic or mild, it may result in severe complications.

In an observational, retrospective cohort study of Israeli pregnant women published in the JAMA on Jul 12, 2021, the BioNTech - Pfizer (Comirnaty, BNT162b2) vaccine was associated with a significantly lower risk of SARS-CoV-2 infection compared with no vaccination.

This study' cohort included 7,530 vaccinated and matched unvaccinated women, 46% and 33% in the second and third trimester, respectively, with a mean age of 31.1 years. The median follow-up for the primary outcome was 37 days.

These researchers found 118 SARS-CoV-2 infections in the vaccinated group and 202 in the unvaccinated group.

Among infected women, (83.8%) were symptomatic in the vaccinated group vs. (83.2%) in the unvaccinated group.

Furthermore, during 28 to 70 days of follow-up, there were 10 infections in the vaccinated group and 46 in the unvaccinated group.

The hazards of infection were 0.33% vs. 1.64% in the vaccinated and unvaccinated groups, respectively, representing an absolute difference of 1.31% (95% CI, 0.89%-1.74%), with an adjusted hazard ratio of 0.22 (95% CI, 0.11-0.43).

Moreover, this study reported vaccine-related adverse events were reported by 68 patients; none was severe.

The researchers concluded by saying, 'Interpretation of study findings is limited by the observational design.'

Note: Maccabi Healthcare Services established and maintenance of computerized pregnancy and COVID-19 registries. Their assistance was provided as part of their work in the health fund. No one received any additional compensation beyond the usual salary for their contributions. No conflicts were disclosed.

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Obese men with a form of advanced prostate cancer survive longer than overweight and normal-weight patients, new research has found. Although obesity is usually associated with an increased risk of death from many cancers and some other chronic diseases, there is some evidence in a few cancers of a survival advantage for patients with a high body mass index.

This phenomenon is known as the ‘obesity paradox.'

The study, presented today at the European Association of Urology Congress on July 8, 2021, followed more than 1,500 patients over three years. Patients classed as obese – with a BMI over 30 – had a 10% higher survival rate than thinner men.

At San Raffaele University in Italy and Mount Sinai Hospital in New York, NY, Alberto Martini and colleagues wanted to test whether the ‘obesity paradox’ held for patients with metastatic castration-resistant prostate cancer – an advanced form of the disease that no longer responds to testosterone lowering treatments.

”Nevertheless, we would not recommend weight gain to anyone with this or another disease. Obesity is a risk factor for many cancers and other diseases, and patients should always aim for a healthy BMI of 18 to 24.”

Professor Peter Albers, from Düsseldorf University, who chairs the EAU Scientific Congress Office, said: “There are many possible explanations for the association of body weight with a positive outcome in metastatic cancers. For example, it might be that patients with higher BMI can tolerate the toxicity of the treatments and their side effects better; in prostate cancer, it might be due to the protective impact of hormones found in tissue fat; and it is known that healthy men with slightly higher BMI have a higher overall life expectancy compared to very slim ones.

“However, at the moment, these are just hypotheses. Further research is needed to identify the biological mechanism behind these different outcomes. Until that mechanism is proven, we can’t recommend any change to treatment for patients with advanced prostate cancer.”

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A little bit of coronavirus vaccine goes a long way towards generating lasting immunity, wrote researchers in an article published by the journal Nature on July 9, 2021.

These researchers found two vaccine doses, each containing only one-quarter of the standard dose of the Moderna COVID-19 (SpikeVax) vaccine, gave rise to long-lasting protective antibodies and virus-fighting T cells, according to tests in nearly three dozen people.

To determine whether a low dose might offer protection, scientists analyzed blood from 35 participants in the original trial. Each had received two 25-microgram jabs of vaccine 28 days apart.

Six months after the second vaccine dose, nearly all participants had ‘neutralizing’ antibodies, which block the virus from infecting cells, the researchers reported in a non-peer-reviewed preprint published on July 5, 2021.

Participants’ blood also contained an armada of different T cells, both ‘killer’ cells that can destroy infected cells and various ‘helper’ cells that aid in general immune defense.

Levels of both antibodies and T cells were comparable to those found in people who have recovered from COVID-19.

“It is quite remarkable — and quite promising — that you can easily detect responses for that long a time,” says Daniela Weiskopf, Ph.D., an immunologist at the La Jolla Institute for Immunology in southern California and a co-author of the new study.

These study results hint at the possibility of administering fractional vaccine doses of the U.S. FDA Authorized 100-microgram amount to stretch COVID-19 vaccine supplies and accelerate the global immunization effort, said these researchers.

Note: This work was funded by the NIH NIAID under awards AI142742 and contract Nr. 75N9301900065. This work was additionally supported in part by LJI Institutional Funds and the NIAID under K08 award AI135078 (J.M.D.). These researchers disclosed various industry relationships.

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SINOVAC Biotech Ltd. announced today that it had signed an advance purchase agreement with Gavi, the Vaccine Alliance, on behalf of COVAX Facility, to provide up to 380 million doses of inactivated COVID-19 vaccine, CoronaVac for distribution through the COVAX Facility.

Mr. Weidong Yin, Chairman, President, and CEO of SINOVAC, said in a press statement issued on July 12, 2021, “Our mission at Sinovac is to supply vaccines to eliminate human disease. We appreciate the efforts from international organizations, including WHO and COVAX partners, to accelerate the efforts of disease prevention."

"Sinovac has delivered over one billion doses globally as of the end of June 2021 with the aim of contributing to the accessibility and affordability of Covid-19 vaccines during this pandemic. Further, safety and regular transportation and storage condition of inactivated vaccine supports easy access to the vaccine in every corner on the globe.”

The WHO's Strategic Advisory Group of Experts on Immunization (SAGE) had systematically reviewed and evaluated evidence of vaccine safety and effect of Sinovac’s CoronaVac vaccine, recommending two doses of CoronaVac® for adults aged 18 and above. Following the review by SAGE, the WHO announced its intention to authorize Sinovac’s CoronaVac for Emergency Use on June 1, 2021.

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The Embassy of the United States in Port-au-Prince, Haiti, issued a Security Alert on July 9, 2021, reminding U.S. citizens of the current Level Four Travel Advisory for Haiti (“do not travel”). 

'Given the reopening of airports to commercial flights, we strongly encourage those U.S. citizens who are in-country to avail themselves of the opportunity to depart Haiti, especially if they feel at risk or threatened in any way.' 

The Embassy suggests these actions to take:

  • Avoid demonstrations and crowds.
  • Do not attempt to drive through roadblocks; and
  • If you encounter a roadblock, turn around and get to a safe area.
  • Monitor local media for breaking events and be prepared to adjust your plans.
  • Keep travel documents up to date and easily accessible.
  • Have evacuation plans that do not rely on U.S. government assistance.
  • Make contingency plans to leave the country.

The U.S. Consular Section is resuming limited services starting Monday, July 12, 2021. If you have an emergency, please refer to our website for information regarding obtaining appointments or contacting the staff.

The U.S. Embassy Port-au-Prince, Haiti, is located at Tabarre 41, Route de Tabarre. Emergencies: +509-2229-8000; Non-emergency inquiries: [email protected]; Website: https://ht.usembassy.gov/ 

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The European Centre for Disease Prevention and Control reported on July 2, 2021, from January 2021 to June 29, 2021, 10 MERS-CoV cases have been reported in the Kingdom of Saudi Arabia (9) and the United Arab Emirates (1), including five deaths.

In Saudi Arabia, all were primary cases, of whom six reported contact with camels. These nine cases were reported in Riyadh (4), Makkah (3), and the Eastern Province (2).

Since April 2012, and as of June 29, 2021, the ECDC reported 2,591 cases of MERS-CoV, including 941 deaths, have been reported by health authorities worldwide.

A previous study published on April 30, 2021, investigated the evolution of human coronaviruses (HCoVs). In this study, the researchers studied amplified fragments of ORF1a/b, Spike (S) gene, ORF3/4a, and ORF4b of four human MERS-CoV strains for tracking the evolution of MERS-CoV over time.

This study concluded 'MERS-CoV appears to evolve continuously. Therefore, it is recommended that future MERS-CoV strains' molecular and pathobiological characteristics be analyzed regularly to prevent potential future outbreaks at early phases.'

As of July 11, 2021, the U.S. FDA has not Approved any MERS vaccine candidates.

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As part of Pfizer’s and BioNTech’s continued efforts to stay ahead of the coronavirus causing COVID-19 and circulating mutations, the companies provided an update on July 8, 2021, focused on their comprehensive Comirnaty vaccine booster strategy.

Pfizer and BioNTech stated they have seen encouraging data in the ongoing booster trial of a third dose of the current Comirnaty - BNT162b2 vaccine. Initial data from the study demonstrate that a booster dose given 6 months after the second dose has a consistent tolerability profile while eliciting high neutralization titers against the wild type and the Beta variant, which are 5 to 10 times higher than after two primary doses. 

The companies expect to publish more definitive data soon as well as in a peer-reviewed journal. In addition, they plan to submit the data to the FDA, EMA, and other regulatory authorities in the coming weeks.

In addition, data from a recent Nature paper demonstrate those immune sera obtained shortly after dose 2 of the primary two-dose series of Comirnaty - BNT162b2 have strong neutralization titers against the Delta variant (B.1.617.2 lineage) in laboratory tests.

The companies anticipate that a third dose will boost those antibody titers even higher, similar to how the third dose performs for the Beta variant (B.1.351).

Pfizer and BioNTech are conducting preclinical and clinical tests to confirm this hypothesis.

While Pfizer and BioNTech believe the third dose of Comirnaty - BNT162b2 has the potential to preserve the highest levels of protective efficacy against all currently tested variants, including Delta, the companies are remaining vigilant and are developing an updated version of the Comirnaty Pfizer-BioNTech COVID-19 vaccine that targets the full spike protein of the Delta variant. 

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The Saudi Press Agency reported on July 8, 2021, digital registration for male and female pilgrims planning to perform Hajj this year was completed. The Ministry of Hajj and Umrah announced as many as 60,000 multinational eligible candidates representing 150 countries from inside the Kingdom of Saudi Arabia had been selected since the start of the process on the 3rd of Dhul-Qa’dah 1442 H.

Deputy Minister of Hajj and Umrah, Dr. Abdelfattah bin Suleiman Mashat, said in a press release that the number of registered pilgrims for this year reached 558,270 pilgrims in the first stage of registration which ended on Thursday 28 Dhu al-Qa’dah 1442 H.

Later eligible candidates were chosen according to several conditions, including age and those performing the ritual for the first time, in addition to adhering to precautionary and preventive measures.

The Ministry also called on all pilgrims who have been granted Hajj permits this year to take the second COVID-19 vaccine dose, as they will be receiving it without booking an appointment in advance.

The Ministry of Hajj and Umrah clarified that pilgrims would be received on the 7th and 8th of Dhul-Hijjah at four reception centers. After that, they will be transported by bus to the Holy Mosque in Makkah to perform Arrival Tawaf (circumambulation) before heading to the Holy Sites.

The Saudi Embassy says 'Undertaking the Hajj at least once is a duty for Muslims who are physically and financially able to make the journey to Makkah. The emphasis on financial ability is meant to ensure that a Muslim takes care of his family first. The requirement that a Muslim be healthy and physically capable of undertaking the pilgrimage is intended to exempt those who cannot endure the rigors of extended travel.'

'The pilgrimage is the religious high point of a Muslim's life and an event that every Muslim dreams of undertaking. Hajj is performed during a five-day period from the ninth through the thirteenth of Dhu Al-Hijjah, the twelfth month of the Muslim lunar calendar.

Hajj 2021 will begin on the evening of Saturday, July 17, 2021.

On July 1, 2021, the U.S. CDC issued a Level 3 Travel Alert stating: the CDC recommends that Americans already 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.'

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The US Centers for Disease Control and Prevention (CDC) published the latest Influenza Surveillance reported on July 9, 2021, without much new news. Nationwide during Week #26, 1.2% of patient visits reported were due to Influenza-like Illness. This percentage is below the national baseline of 2.6% for this time of year.

According to the CDC, mortality surveillance data available on July 8, 2021, 6.2% of the deaths that occurred during the week ending July 3, 2021 (week 26) were due to pneumonia, influenza, and/or COVID-19 (PIC).

Among the 971 PIC deaths reported to the CDC, 333 had COVID-19 listed as an underlying or contributing cause of death on the death certificate. None listed influenza, indicating that current PIC mortality is due primarily to COVID-19 and not influenza.

In addition, only (1) influenza-associated pediatric death occurred during the 2020-2021 flu season—this data contrasts with the last flu season when (199) pediatric deaths were reported.

Globally, the World Health Organization (WHO) recently reported similar news regarding influenza. 

The WHO Global Influenza Surveillance and Response System laboratories tested more than 146,816 specimens and found only 766 specimens positive for influenza viruses as of July 5, 2021. And in many areas of the world, no influenza detections were reported.

The good news is influenza vaccines for the 2021-2022 flu season in the Northern Hemisphere will soon become available in most pharmacies, health clinics, and hospitals. Over 193 million flu shots have been produced to protect people from the various influenza viruses. The CDC suggests most people 6-months of age and above get an annual flu shot.

An updated listing of authorized flu shots is published on this webpage.

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The JAMA published a Viewpoint on July 7, 2021, addressing 'Lay Epidemiology' and COVID-19 vaccine acceptance. Across cultures, people try to make sense of the world around them, including how likely it is that a negative outcome will occur for them and increase or reduce that risk.

This concept has been referred to as Lay Epidemiology. 

Lay Epidemiology is how inferences are drawn from disease patterns in small groups like friends and family, larger groups from social media or other sources, and even entire populations from public information or news stories.

From the Lay Epidemiologic perspective, it makes sense that groups with clear evidence of experiencing worse outcomes from most aspects of the health care system should be skeptical of the information about the average risks and benefits of vaccination.

In fact, lack of confidence is a rational response to these experiences.

While lay epidemiology is far from the only factor driving vaccine hesitancy, it is too often overlooked.

In many communities, vaccination rates increase as people see their friends, colleagues, and neighbors get vaccinated without adverse events. But in some areas, vaccine uptake is lagging, and efforts to address lay epidemiology may be an important factor in ensuring that the USA can reach COVID-19 vaccination goals over the months ahead.

To read the full Viewpoint written by Sudhakar V. Nuti, M.D., and Katrina Armstrong, M.D., please visit this JAMA weblink.

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