Coronavirus Breaking News

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Jul 3, 2021 • 7:54 am CDT

Pregnant Women in India Receive COVID-19 Vaccine Authorization

The India Health Ministry announced on July 2, 2021, that pregnant women are now eligible for Covid-19 vaccination at any time of the pregnancy.

The Ministry stated said that although most infected pregnant women (>90%) recover without the need for hospitalization, “rapid deterioration in health may occur in the women and could also affect the fetus health.” The statement adds that most newborns (95%) of Covid-positive mothers have been in good condition at birth.

Additionally, 'experts are of the view that the benefits of vaccination to the pregnant women outweigh its potential risks.'

'Based on the recommendations from National Technical Advisory Group on Immunization, India Health Ministry has approved vaccination of pregnant women against COVID-19 with the condition that the pregnant women may be informed about the risks of exposure to COVID-19 infection along with the risks and benefits associated with the COVID-19 vaccines available in India. Based on the information provided, a pregnant woman will have the choice to take the vaccination.'

Three vaccines have been authorized by the Central Drugs Standard Control Organization in India, Covishield® (AstraZeneca's vaccine manufactured by Serum Institute of India) and Covaxin® (manufactured by Bharat Biotech Limited), and Sputnik V.

Local media reported on July 1, 2021, indicate India's government expert panel has said the Phase 3 trial data for the single-dose Sputnik Light vaccine could be submitted by Dr. Reddy's.

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Jul 2, 2021 • 3:22 pm CDT

Moscow Accelerates Vaccinations Against Delta Variant

Russian leaders stated on July 2, 2021, they 'will not impose a new lockdown despite a rising coronavirus death toll that has reached a daily record number for four days straight,' reported Radio Free Europe. A surge in COVID-19 cases driven by the highly infectious Delta coronavirus variant.

"Nobody wants any lockdowns. And yes, it is not up for debate," Dmitry Peskov told reporters. "which is why...we must all be vaccinated as soon as possible."

Health clinics in Moscow begin offering booster vaccinations against COVID-19 on July 1st, the city's mayor said, reported Reuters. Moscow Mayor Sergei Sobyanin said re-vaccination was available with any of Russia's four registered vaccines. Still, Sputnik V and the one-dose Sputnik Light vaccine would initially be used at eight clinics across Moscow, a city with over 12 million residents.

Scientists have said that protection from the Sputnik V vaccine lasts much longer than six months.

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Jul 2, 2021 • 4:25 am CDT

Can COVID-19 Immunity Last Years?

Many questions remain about natural and vaccine-induced immunity to the SARS-CoV-2 beta coronavirus since it is a new virus. In addition, when the body’s immune system responds to a new infection, it isn’t always clear how long any immunity that develops will persist.

Furthermore, COVID-19 is a very different disease than other coronavirus-caused illnesses. Scientists around the globe are still working out precisely how the body fends off the virus and how to treat the disease it causes.

Chris Baraniuk reviews what we know so far... click here more the full BMJ article.

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Jul 1, 2021 • 1:13 pm CDT

Myocarditis Cases Identified in US Military Following mRNA COVID-19 Vaccination

The JAMA Cardiology published a case series of 23 male patients, including 22 previously healthy military members, on June 29, 2021. Myocarditis, a heart condition, was identified within 4 days of receipt of an mRNA COVID-19 vaccine.

For most patients (n = 20), the diagnosis was made after the second dose of the mRNA COVID-19 vaccination.

These cardiology episodes occurred against the backdrop of 2.8 million doses of mRNA COVID-19 vaccines administered. COVID-19 vaccines are available under pre-licensure statuses, such as an Emergency Use Authorization, and are not U.S. FDA Approved, and are voluntary for Service members, though highly encouraged.

'We are at 68% of active duty who are vaccinated with at least one dose, and we continue our efforts to encourage our service members, families, and beneficiaries to become vaccinated,' stated Acting Assistant Secretary Of Defense For Health Affairs Dr. Terry Adirim on June 30, 2021.

Throughout the eighteen-month pandemic, the U.S. DOD has confirmed (26) active-duty fatalities related to COVID-19.

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Jul 1, 2021 • 9:41 am CDT

UK Preps 3rd COVID-19 Vaccinations for September

Public Health England announced the Joint Committee on Vaccination and Immunisation (JCVI) had been asked to consider the options for a potential COVID-19 booster program.

As of June 30, 2021, the JCVI’s interim advice is that any potential COVID-19 booster program should be offered in two stages beginning September 2021, starting with those most at risk from serious disease.

This group includes homecare residents, people aged over 70, frontline health and social care workers, clinically extremely vulnerable adults, and those who are immunosuppressed.

Professor Wei Shen Lim, COVID-19 Chair for JCVI, said in a statement, 'The primary objective of any potential COVID-19 booster vaccine program should be to reduce serious disease, including death.'

'The JCVI’s interim advice is that, should a booster program be required, a third COVID-19 vaccine dose should be offered to the most vulnerable to maximize individual protection and safeguard ahead of winter. Almost all these people would also be eligible for the annual flu vaccine and are strongly advised to have the flu vaccine.'

'We will continue to review emerging scientific data over the next few months, including data relating to the duration of immunity from the current vaccines. As a result, our final advice on booster vaccination may change substantially.'

'As most younger adults (16+) will only receive their second COVID-19 vaccine dose in late summer, the benefits of booster vaccination in this group will be considered at a later time when more information is available.'

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Jun 30, 2021 • 2:07 pm CDT

Delta Variant Infects COVID-19 Vaccinated People

Public Health England (PHE) published 'SARS-CoV-2 variants of concern and variants under investigation in England Technical Briefing #17 on June 25, 2021. Over the past two weeks, the Delta variant accounted for approximately 95% of sequenced and 92% of genotyped cases identified in England.

According to BusinessInsider reporting on June 28, 2021, of those who were fully vaccinated who caught the Delta variant, 50 died. The data represents about 45% of the total 117 deaths associated with the Delta variant in the UK.

PHE's Risk Assessment regarding the Delta variant says: 'All analyses continue to support increased transmissibility and reduced vaccine effectiveness against symptomatic infection. The interplay between the current findings of increased risk of hospitalization and preserved vaccine effectiveness against hospitalization requires careful consideration.'

'It is too early to assess the case fatality ratio than other variants,' says PHE.

The COVID-19 vaccines currently approved for use in the UK are from Moderna, AstraZeneca, and Pfizer - BioNTech.

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Jun 30, 2021 • 9:39 am CDT

UK's COVID-19 Vaccinations Have Prevented 27,000 Related Fatalities

The latest modeling analysis from Public Health England (PHE) and the University of Cambridge’s MRC Biostatistics Unit published on June 28, 2021, suggests that the COVID-19 vaccination program has so far prevented an estimated 7.2 million infections and 27,000 deaths in England alone.

This is the first analysis giving an estimated number of vaccine-prevented infections, providing further evidence of the staggering impact of the vaccination program so far.

PHE Head of Immunisation Dr. Mary Ramsay said in a related press statement, "These findings remind us once again why getting both doses of your vaccine is the most important thing you can do to stop the spread of this terrible disease."

"As well as preventing the deaths of tens of thousands from COVID-19, for the first time, we can now appreciate the huge impact that the vaccines have had on stopping people getting infected, and therefore passing the virus on to others."

Coronavirus restrictions remain in place across the UK, including for people who have been vaccinated. In England: You can meet indoors in a group of up to 6 people or a group of any size from 2 households; You can meet outside in a group of up to 30 people; Work from home if you can and travel safely; If you have symptoms get a test and stay at home, says PHE.

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Jun 30, 2021 • 6:06 am CDT

Gavi Purchases 414 Million COVID-19 Vaccines from China

China-based Clover Biopharmaceuticals announced an advance purchase agreement with Gavi, the Vaccine Alliance, to provide up to 414 million doses of its protein-based SCB-2019 COVID-19 vaccine candidate (CpG 1018/Alum) for procurement through the COVAX Facility.

Pending an Emergency Use Listing from the World Health Organization for Clover’s COVID-19 vaccine candidate, Clover will make an initial 64 million doses available for procurement through the COVAX Facility in 2021.

Gavi also retains options to procure up to an additional 350 million doses to be delivered in 2022.

“The pandemic continues to evolve, and to be best prepared, COVAX’s actively managed, diverse portfolio will be critical to meeting countries’ needs and protecting against risks such as regulatory delays, variant and supply constraints,” said Dr. Seth Berkley, CEO of Gavi, in a press statement issued on June 30, 2021.

“Today’s agreement with Clover Biopharmaceuticals is yet another important step in that direction.”

The COVAX Facility is a global risk-sharing mechanism for pooled procurement and equitable distribution of COVID-19 vaccines that currently includes more than 190 participating economies, designed and administered by Gavi, the Vaccine Alliance.

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Jun 30, 2021 • 4:09 am CDT

Which Coronavirus Variants are Present in Europe?

Developed by the European Centre for Disease Control (ECDC), a new Vaccine Tracker and dashboard offers travelers insights into which SARS-CoV-2 virus variants are currently found in the EU and EEA (European Economic Area) countries.

The dashboard shows the proportion of variants of concern and interest, namely the United Kingdom (B.1.1.7), South Africa (B.1.351), Brazil (P.1), and India (B.1.617.1, B.1.617.2, B.1.617.3) variants, and their sequencing volumes.

The data is obtained from the European Surveillance System and the GISAID EpiCoV database, which monitor these data weekly. The ECDC information is updated every Thursday and can be easily filtered to show a specific country, a week, or only data above a given sequencing volume.

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Jun 29, 2021 • 12:03 pm CDT

mRNA COVID-19 Vaccines Offer Suboptimal Immunity for Blood Cancer Patients

According to a New York-City-based Mount Sinai Health System press release, people with a type of blood cancer called multiple myeloma were found with variable responses to mRNA COVID-19 vaccines, in some cases, no detectable immune response.

Mount Sinai researchers found that multiple myeloma patients mount variable and sometimes suboptimal responses after receiving the Pfizer-BioNTech or Moderna COVID-19 vaccines.

Almost 16% of these patients developed no detectible antibodies after both vaccine doses. Patients on active cancer treatment had significantly lower antibody levels after two vaccine doses than multiple myeloma patients who were not on treatment at the time of vaccination.

These findings may be relevant to other cancer patients undergoing treatment and to immunocompromised patients. This new study was published in the journal Cancer Cell on June 29, 2021.

"This study underscores the need for routine blood tests on multiple myeloma patients after vaccination to understand their risk and the potential need to continue wearing masks and socially distance until the pandemic wanes," stated co-lead author Samir Parekh, M.D., Director of Translational Research in Multiple Myeloma at The Tisch Cancer Institute at Mount Sinai and Professor of Medicine, and Oncological Sciences, at the Icahn School of Medicine at Mount Sinai.

"This also calls for clinical trials to study the use of prophylactic therapies, like monoclonal antibodies, to mitigate COVID-19 risk or to use of different vaccines or booster vaccinations in these patients."

The Mount Sinai Health System is New York City's largest academic medical system, encompassing eight hospitals, a leading medical school, and a vast network of ambulatory practices throughout the greater New York region.

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Jun 28, 2021 • 11:10 am CDT

41 Countries Against Pregnant Women and COVID-19 Vaccination

As of June 28, 2021, forty-one countries recommend against vaccinating pregnant women, according to the COVID-19 Maternal Immunization Tracker (COMIT) from Johns Hopkins University, located in Maryland.

And just 17 explicitly recommend that some or all pregnant women should receive a COVID-19 vaccination.

'Because this is a dynamic space, with countries and other recommending bodies continuing to update their positions based on the changing epidemiological situation, emerging evidence on vaccine products, and growing understanding of risks of COVID-19 disease in pregnancy, COMIT is updated regularly to reflect changes in policy positions,' says COMIT website.

Currently, there are 18 vaccines in use globally, and GAVI reports about (102) COVID-19 vaccine candidates are undergoing clinical trials.

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Jun 27, 2021 • 8:35 am CDT

Delta Variant Will Dominate Europe's COVID-19 Pandemic

The European Centre for Disease Prevention and Control (ECDC) reported on June 23, 2021, based on the available evidence, the SARS-CoV-2 Delta (B.1.617.2) variant of concern (VOC) is 40-60% more transmissible than the Alpha (Β.1.1.7) VOC and may be associated with a higher risk of hospitalization.

Based on the ECDC's estimated transmission advantage of the Delta variant and using modeling forecasts, 90% of new SARS-CoV-2 infections are projected due to this variant in the EU/EEA by the end of August 2021.

Since the ECDC’s most recent risk assessment was published on June 10, 2021, and given the expected future predominance of the Delta variant, the risk has increased for countries in all epidemiological situations.

'To achieve maximum protection in the shortest time possible, it is recommended that individuals at highest risk of severe outcomes for SARS-CoV-2 receive a second vaccine dose in the shortest possible interval following the administration of the first dose,' says the ECDC.

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Jun 27, 2021 • 6:15 am CDT

UK Confirms 54% Increase in COVID-19 Cases

The United Kingdom reported on June 26, 2021, the greatest number of SARS-CoV-2 coronavirus infections since February 2021. Between June 20, 2021, and June 26, 2021, 98,460 people had a confirmed positive test result. The new data indicates an increase of 54% compared to the previous 7 days.

This map has been updated to show where in the UK new COVID-19 cases are being confirmed. The vast majority of cases and related fatalities were confirmed in England.

Public Health England confirmed in its weekly update that the Delta variant now makes up 95% of sequenced COVID-19 cases.

Additionally, the UK's health minister, Matt Hancock, resigned his post.

Hancock posted a video on Twitter that stated, "I understand the enormous sacrifices that everybody in this country has made, that you have made, and those of us who make these rules have got to stick by them, and that's why I have got to resign."

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Jun 26, 2021 • 6:21 am CDT

COVID-19 Monoclonal Antibody Treatment Paused in the USA

The US Assistant Secretary for Preparedness and Response (ASPR) and the Food and Drug Administration (FDA) announced they are immediately pausing the distribution of the monoclonal antibody therapy cocktail bamlanivimab and etesevimab on a national basis until further notice.

In addition, the FDA recommended late on June 24, 2021, that healthcare providers use an alternative authorized monoclonal antibody therapy, such as Regeneron's REGEN-COV and sotrovimab, and not use the combination of bamlanivimab and etesevimab at this time.

REGEN-COV and sotrovimab are currently authorized for the same use as bamlanivimab and etesevimab administered together.

The reason for this national alert is the Centers for Disease Control and Prevention (CDC) has identified that the SARS-CoV-2 P.1/Gamma variant (Brazil) and the B.1.351/Beta variant (South Africa) now exceed 11% and are trending upward throughout the USA.

Furthermore, in vitro assays used to assess the susceptibility of viral variants to particular monoclonal antibodies suggest that Eli Lilly's bamlanivimab and etesevimab administered together are not active against either the P.1 or B.1.351 variants.

And based on similar in vitro assay data currently available, REGEN-COV and sotrovimab are likely to retain activity against the P.1 or B.1.351 variants.

All treatment delivery sites in the USA can continue ordering REGEN-COV from the authorized distributor and may also find information on the availability and ordering of sotrovimab by visiting GlaxoSmithKline’s website at www.sotrovimab.com.

Additionally, healthcare providers should review the Antiviral Resistance information in Section 15 of the authorized Fact Sheets for each monoclonal antibody therapy available under a EUA for details regarding specific variants and resistance.

Monoclonal antibody therapies available under a EUA must be used per the terms and conditions for the respective authorization, including the authorized labeling. The Letters of Authorization may be accessed at this link.

The ASPR and FDA confirmed they would continue to work with the CDC to provide further updates as new information becomes available.

Please contact COVID19Therapeutics@hhs.gov with any questions.

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