Coronavirus Breaking News

Feb 13, 2021 • 7:21 am CST

Southerner California Reports Coronavirus Variants Cases

According to a JAMA research letter published on February 11, 2021, researchers at Cedars-Sinai Medical Center in Los Angeles, California, found a new SARS-CoV-2 coronavirus variant CAL.20C.

Unlike clade 20G, currently the most frequently reported clade in North America, this strain is defined by 3 mutations in the S-protein, characterizing it as a subclade of 20C.

The S protein L452R mutation is within a known receptor binding domain resistant to specific spike (S) protein monoclonal antibodies.

These researchers commented 'that the behavior of CAL.20C is yet unknown.'

"Additionally, as clinical outcomes have yet to be established, the functional effect of this strain regarding infectivity and disease severity remains uncertain," they wrote. "Nevertheless, the identification of this novel strain is important to the frontline and global surveillance of this evolving virus."

As of February 11, 2021, the U.S. CDC reported the following number of SARS-CoV-2 variant cases:

UK B.1.1.7 = 981
South Africa B.1.351 = 13
Brazil P.1 = 3

The state of California had reported 161 variant cases, the second-most in the USA.

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Feb 12, 2021 • 2:52 pm CST

Canada Accelerates COVID-19 Vaccine Deliveries

The Honourable Anita Anand, Minister of Public Services and Procurement announced on February 12, 2021, that Canada has negotiated an accelerated delivery schedule for Pfizer-BioNTech’s COVID-19 vaccine (Comirnaty) and will receive all 40 million of its secured doses from Pfizer-BioNTech by the end of September.

This means that Canada will receive 2.8 million additional doses of the Comiranty vaccine between April and June 2021 and an extra 6.2 million doses between July and September 2021.

The Government of Canada has also purchased an additional 4 million doses of the Moderna COVID-19 vaccine. The extra 4 million doses are expected to arrive by the end of September.

Canada is now expected to receive 84-million doses of Pfizer-BioNTech and Moderna vaccines by the end of September 2021.

“Our government continues to put every effort forward to protect Canadians from COVID-19. This includes taking all necessary measures to accelerate vaccine deliveries to Canada from approved suppliers. We remain fully on track to ensure that every eligible Canadian who wishes to be vaccinated will be able to do so by the end of September," stated Anand in a press release.

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Feb 12, 2021 • 1:49 pm CST

USA Purchases 100 Million COVID-19 Vaccines for $1.95 Billion

BioNTech SE and Pfizer Inc. announced today the U.S. government had exercised its option for an additional 100 million doses of the Pfizer-BioNTech COVID-19 vaccine known as Comirnaty. This order increases the total number of vaccine doses to be supplied by these companies to the U.S. government to 300 million.

Consistent with the agreements for the prior 200 million doses, the U.S. government will pay $1.95 billion for the additional 100 million doses.

“It is our objective to supply as many doses of our COVID-19 vaccine as possible to people in order to help end this pandemic, reduce the hospitalization of especially elderly people and bring us back to our normal lives,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech, in a press statement issued on February 12, 2021.

Pfizer’s facility in Kalamazoo, MI, remains the primary manufacturing site of the Pfizer-BioNTech COVID-19 vaccine in the USA.

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Feb 12, 2021 • 1:15 pm CST

'Better, But Not Good Enough'

The US Centers for Disease Control and Prevention (CDC) stated on February 12, 2021, 'Don’t let your guard (or mask) down. COVID-19 cases, hospitalizations, and deaths continue to trend downward.'

The CDC's recent report indicates the daily number of COVID-19 cases has declined by 69% since January 8, 2021.

Furthermore, since the COVID-19 Vaccination Program began December 14, 2020, about 34.7 million people have received at least one vaccine dose, which is 10.5% of the U.S. population.

'But even with that progress, the daily numbers of new cases and deaths remain much higher than the first two peaks of the pandemic in the spring and summer of 2020,' said the CDC's latest report.

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Feb 12, 2021 • 9:38 am CST

Europe Reviews Another German COVID-19 Vaccine

Germany-based CureVac N.V. announced the initiation of a rolling submission with the European Medicines Agency (EMA) for CVnCoV, the company’s mRNA-based COVID-19 vaccine candidate, currently in late-stage clinical testing.

On February 12, 2021, the EMA stated it will assess CVnCoV's compliance 'with the usual standards for effectiveness, safety, and pharmaceutical quality. While EMA cannot predict the overall timelines, it should take less time than usual to evaluate an eventual application because of the work done during the rolling review.'

The CVnCoV vaccine candidate is currently being investigated in a randomized, observer-blind, placebo-controlled Phase 2b/3 clinical trial called HERALD in healthy adults at a dose of 12 µg at sites in Europe and Latin America.

“We are confident in the potential of our mRNA technology to contribute to the fight against the global public health emergency that is COVID-19,” said Dr. Lidia Oostvogels, Vice President Area Head Infectious Diseases at CureVac, in a press release. “Working together with the EMA to initiate a rolling regulatory process is a critical step in enabling potential access to our vaccine by the many people who still need protection from this deadly disease.”

The EMA initially authorized BioNTech SE's mRNA Vaccine known as Comirnaty during December 2020.

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Feb 12, 2021 • 8:36 am CST

26 Countries Have Authorized the Sputnik V Vaccine

The Russian Direct Investment Fund announced the Sputnik V vaccine's approval in Montenegro, Saint Vincent, and the Grenadines. As of February 12, 2021, twenty-six countries had authorized the Sputnik V Vaccine.

These countries included Russia, Belarus, Argentina, Bolivia, Serbia, Algeria, Palestine, Venezuela, Paraguay, Turkmenistan, Hungary, UAE, Iran, Republic of Guinea, Tunisia, Armenia, Mexico, Nicaragua, Republika Srpska (Bosnia and Herzegovina), Lebanon, Myanmar, Pakistan, Mongolia, Bahrain, Montenegro, Saint Vincent, and the Grenadines.

Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said in a press release, “Clinical trial data published in The Lancet medical journal on February 2, 2021, demonstrated high efficacy and safety of the vaccine."

Denis Logunov and colleagues reported interim results from a phase 3 trial of the Sputnik V vaccine showing a consistent strong protective effect across all participant age groups. Also known as Gam-COVID-Vac, the Russian vaccine uses a heterologous recombinant adenovirus approach using adenovirus 26 (Ad26) and adenovirus 5 (Ad5) as vectors for the expression of the SARS-CoV-2 coronavirus spike protein.

Dmitriev continued saying, "Sputnik V is recognized globally as one of the key vaccines which will help protect humankind and return to normal life.”

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Feb 11, 2021 • 4:11 pm CST

Qatar Authorizes Moderna's COVID-19 Vaccine

Massachusetts-based Moderna, Inc. announced on February 11, 2021, the Qatar Ministry of Public Health had issued an emergency use authorization for COVID-19 Vaccine Moderna. The approval is based on the totality of scientific evidence shared by the Company, including a data analysis from the pivotal Phase 3 clinical study announced on November 30.

Qatar has secured COVID-19 Vaccine Moderna access through a supply agreement announced on October 26, 2020.

“I want to thank the Qatar Ministry of Public Health for this authorization, which marks an important step forward in the global fight against COVID-19. We appreciate their continued confidence in our mRNA vaccine,” commented Stéphane Bancel, Chief Executive Officer of Moderna, in a press statement.

The Moderna COVID-19 Vaccine (mRNA-1273) is an mRNA vaccine candidate against the novel coronavirus SARS-CoV-2 encoding for a prefusion stabilized form of the Spike protein selected by Moderna in collaboration with investigators NIAID Vaccine Research Center.

Moderna has previously received authorization for its COVID-19 vaccine from health agencies in the United States, Canada, Israel, the European Union, the United Kingdom, Switzerland, and Singapore.

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Feb 11, 2021 • 2:23 pm CST

Fomites Unlikely Sources of SARS-CoV-2 Virus

The World Health Organisation (WHO) and US Centers for Disease Control and Prevention (CDC) have updated the SARS-CoV-2 infection control advice to reflect the current state of virus transmission evidence, as of February 10, 2021. The focus on 'fomites' emerged at the beginning of the COVID-19 outbreak in early 2020 because of what researchers assumed about infectious diseases.

The CDC stated during 2020 that while it’s possible respiratory droplets infected with the new coronavirus could land on surfaces and that someone could become infected by touching them, “this is not thought to be a common way that COVID-19 spreads."

Also, “despite consistent evidence as to SARS-CoV-2 contamination of surfaces and the survival of the virus on certain surfaces, there are no specific reports which have directly demonstrated fomite transmission,” said the WHO.

“Fomite transmission is possible, but it just seems to be rare,” says environmental engineer Amy Pickering, who is now at the University of California, Berkeley. “A lot of things have to fall into place for that transmission to happen," reported the journal Nature on January 29, 2021.

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Feb 11, 2021 • 10:47 am CST

Interim Clinical Recommendations Issued for COVID-19 Vaccinated Persons

The US Centers for Disease Control and Prevention (CDC) published Interim Clinical Guidelines on February 11, 2021, which included, but is not limited to, insights for COVID-19 vaccinated persons.

'While experimental mRNA COVID-19 vaccines have demonstrated high efficacy at preventing severe and symptomatic COVID-19, there is currently limited information on how much the vaccines might reduce transmission and how long protection lasts.'

Also, 'the efficacy of the vaccines against emerging SARS-CoV-2 virus variants is unknown.'

'At this time, the CDC suggests 'vaccinated persons should continue to follow current guidance to protect themselves and others, including wearing a mask, staying at least 6 feet away from others, avoiding crowds, avoiding poorly ventilated spaces, covering coughs and sneezes, washing hands often, following CDC travel guidance, and following any applicable workplace or school guidance, including guidance related to personal protective equipment use or SARS-CoV-2 testing.'

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Feb 10, 2021 • 4:16 pm CST

South Africa to Launch Janssen's COVID-19 Vaccine

South African health leaders announced during a digital news conference broadcast via Youtube on February 10, 2021, the country would soon administer the experimental COVID-19 vaccine produced by Janssen Pharmaceuticals, a Johnson and Johnson company.

South African Minister of Health Zweli Mkhize stated the Janssen vaccine “has been proven effective against the 501Y.V2 variant and the necessary approval processes for use in South Africa are underway.”

In a statement to The Hill, Johnson & Johnson said it is in “advanced discussions with the South African government. We are committed to addressing the needs of the most vulnerable and at-risk populations worldwide and to supporting a further clinical understanding of the variants to help stop their spread."

On January 13, 2021, the NEJM published Interim Results of Phase 1–2a Trial,' which stated: 'The interim analysis of our phase 1–2a trial showed that the Ad26.COV2.S vaccine (JNJ-78436735) had an acceptable safety and reactogenicity profile and was immunogenic after a single vaccination with either the low or high dose.'

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Feb 10, 2021 • 6:20 am CST

Taiwan and Columbia Purchase COVID-19 Vaccines

Cambridge-based Moderna, Inc. announced supply agreements for the COVID-19 Vaccine Moderna: one with the government of Taiwan for 5 million doses and another with Colombia's government for 10 million doses. Under the terms of the agreements, vaccine deliveries would begin in mid-2021.

“We thank the governments for partnering with us to bring the COVID-19 Vaccine Moderna to Taiwan and Colombia. Both governments have moved quickly to get this done in the face of the pandemic, and we appreciate their collaboration,” said Stéphane Bancel, CEO of Moderna, in a press statement.

The COVID-19 Vaccine Moderna is not currently approved for use in Taiwan or Colombia, and the Company will work with regulators to pursue necessary approvals prior to distribution.

On December 18, 2020, the U.S. FDA authorized the Moderna COVID-19 Vaccine emergency use in individuals 18 years of age or older. Moderna has also received authorization for its COVID-19 vaccine from health agencies in Canada, Israel, the European Union, the United Kingdom, Switzerland, and Singapore.

The COVID-19 Vaccine Moderna is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike protein, which was co-developed by Moderna and investigators from the National Institute of Allergy and Infectious Disease’s Vaccine Research Center.

The FDA states people should not get the Moderna COVID-19 Vaccine if they had a severe allergic reaction after a previous dose of this vaccine or have a severe allergic reaction to any ingredient of this vaccine.

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Feb 9, 2021 • 8:09 pm CST

Neutralizing Antibody Combo Therapy Authorized for Certain COVID-19 Patients

Indianapolis-based Eli Lilly & Co. announced on February 9, 2021, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for investigational bamlanivimab (LY-CoV555) 700 mg and etesevimab (LY-CoV016) 1400 mg combination.

This neutralizing antibody therapy is authorized to treat mild to moderate COVID-19 in patients aged 12 and older who are at high risk for progressing to severe COVID-19 and/or hospitalization.

Bamlanivimab and etesevimab should be administered together via a single intravenous infusion as soon as possible after a positive COVID-19 test and within 10 days of symptom onset. In addition, the FDA has authorized infusion times for bamlanivimab alone and bamlanivimab and etesevimab together to be as short as 16 or 21 minutes, respectively – a significant reduction from the previously authorized time of 60 minutes.

Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories, stated in a press release, "Bamlanivimab alone under emergency use authorization has already provided many people with an early treatment option that could prevent hospitalizations. We are excited to now add an additional therapeutic option with a similar demonstrated clinical benefit."

"Additionally, with the risk of resistance emerging as various strains of the virus arise, bamlanivimab and etesevimab together could potentially allow efficacy against a broader range of naturally occurring SARS-CoV-2 coronavirus variants as these new strains spread around the world."

The FDA says, 'Monoclonal antibodies are laboratory-made proteins that mimic the immune system’s ability to fight off harmful pathogens such as viruses. Bamlanivimab and etesevimab are monoclonal antibodies specifically directed against the spike protein of SARS-CoV-2, designed to block the virus’s attachment and entry into human cells. Bamlanivimab and etesevimab bind to different but overlapping sites on the spike protein of the virus.'

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Feb 9, 2021 • 4:58 pm CST

Mother's Breastmilk Found Beneficial with Minimal COVID-19 Risk

Although human milk is considered the best source of nutrition for most infants, the onset of the global COVID-19 pandemic and our lack of understanding of the SARS-CoV-2 coronavirus transmission has caused confusion around whether breastfeeding should be initiated and/or continued during maternal COVID-19 illness.

To answer this question, the American Society for Microbiology published a new study in mBio on February 9, 2021, report that repeated milk samples collected from 18 breast-feeding women following COVID-19 diagnosis did not contain SARS-CoV-2 RNA. Importantly, these researchers found that milk produced by infected mothers is a source of anti-SARS-CoV-2 IgA and IgG and neutralizes SARS-CoV-2 activity.

These results support recommendations to continue breastfeeding during mild-to-moderate maternal COVID-19 illness as milk likely provides specific immunologic benefits to infants.

Furthermore, most infants (83%, 15/18) appeared healthy with no signs of illness, including two whose mothers had detectable viral RNA on their breast skin. However, these three cases had additional household members confirmed to have COVID-19, making it difficult to attribute their symptoms or mode of transmission, in the case of the positive infant, to breastfeeding, said these researchers.

However, the risk of transmission via breast skin should be further evaluated, concluded these researchers.

A previous commentary published by The Lancet on February 4, 2021, concluded stating: To improve maternal-infant health and maintain public confidence in vaccines in handling this pandemic and preparing for the next, vaccine manufacturers and regulators must work closely with lactation scientists, infectious disease specialists, and public health experts to assess vaccine safety in breastfeeding women at early stages of product development.

It is encouraging that many nations, including the United Kingdom, are now adopting a more positive tone around vaccine recommendations for breastfeeding women. However, in many cases, the recommendation's finer points will still lie with individual providers or institutions.

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Feb 9, 2021 • 3:19 pm CST

Canada Confirms Fewer COVID-19 Cases

Public Health Agency of Canada issued a press statement on February 8, 2021, 'As COVID-19 activity continues in Canada, we are tracking a range of epidemiological indicators to monitor where the disease is most active, where it is spreading and how it is impacting the health of Canadians and public health, laboratory, and healthcare capacity.'

'Following the recent decrease in COVID-19 activity, we remain on a gradual decline in severe outcomes as expected with these lagging indicators.'

'Provincial and territorial data indicate that an average of 3,633 people with COVID-19 was being treated in Canadian hospitals each day during the most recent 7-day period (Jan 29-Feb 4), including 736 of whom were being treated in intensive care units. During the same period, there was an average of 121 COVID-19-related deaths reported daily.'

'Across Canada, vaccines are continuing to roll-out to protect those at the highest risk of severe outcomes or exposure. Two COVID-19 vaccines are currently approved for use in Canada: Pfizer-BioNTech and Moderna.'

As of February 9th, 1,068,690 COVID-19 vaccines have been administered, with 52% of prioritized healthcare workers, 27% of the adults in the territories, and 11% of elderly adults over 80 years of age had received at least one dose of a COVID-19 vaccine.

'With now, more than 355 B.1.1.7 variants, 25 B.1.351 variants, and 1 P.1 coronavirus variant reported in Canada, the risk is genuine.'

'But for every dark cloud, there is a silver lining, and we have several advantage points to work from. First and foremost, we know what works to control this virus. Our way forward is clear. Right now, our measures are working. This means doing everything we’ve been doing but giving it the best we can give, at all times,' concluded these comments.

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