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July 9 COVID-19 update: One death, 1273245 vaccines, 36 new cases, 57 recoveries – The Battlefords News-Optimist

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Vaccines Reported

An additional 12,678 doses of COVID-19 vaccine have been given in Saskatchewan, bringing the total number of vaccines administered in the province to 1,273,245.  Over half a million Saskatchewan residents are now fully vaccinated.

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The additional 12,678 doses of COVID-19 vaccine reported today were administered to residents living in the following zones: Far North West, 108; Far North Central, 38; Far North East, 189; North West, 1,121; North Central, 836; North East, 239; Saskatoon, 3,756; Central West, 421; Central East, 930; Regina, 3,038; South West, 416; South Central, 437; and South East, 753.  There were 396 doses administered with zone of residence pending.

Seventy-two per cent of those 12+ have received their first dose and 53 per cent of those 12+ are fully vaccinated.

Status of Population Vaccinations, as of July 8, 2021

Group

Estimated
Population

Received
First Dose

Fully 
Vaccinated

Age 80+

51,352

47,660 (93%)

44,660 (87%)

 Age 70-79

82,304

73,941 (90%)

68,523 (83%)

Age 60-69

140,471

120,669 (86%)

107,213 (76%)

Age 50-59

142,537

112,325 (79%)

91,402 (64%)

Age 40-49

150,870

107,606 (71%)

76,583 (51%)

Age 30-39

178,012

112,819 (63%)

70,645 (40%)

Age 18-29

181,622

108,573 (60%)

57,675 (32%)

Age 12-17

91,446

53,675 (59%)

19,161 (21%)

Covered Population Update

The Saskatchewan Health Coverage Report is a count of persons who were eligible for Saskatchewan health insurance benefits as of June 30, and is the population data utilized by the Ministry of Health when reporting COVID-19 case and vaccination rates.  The covered population data is updated annually and will be incorporated into COVID-19 reporting starting today for the COVID-19 vaccination rates at the provincial level for 12+ population and the age groups.  Note that the other reports will continue to utilize the 2020 covered population numbers in the provincial dashboard until the new data set is fully incorporated with a complete update targeted for the week of July 11.  All vaccine administration details for the province, including first and second doses, can be found at https://dashboard.saskatchewan.ca/health-wellness.

All Residents 12+ Eligible for COVID-19 First and Second Dose Immunizations

All Saskatchewan residents 12 years and older who have received their first dose of vaccine are now eligible to receive their second dose following a 28-day interval.  

Whether seeking your first or second dose, vaccination appointments can be booked through the Saskatchewan Health Authority online at www.saskatchewan.ca/COVID19 or by calling 1-833-SaskVax (1-833-727-5829).  Street addresses and hours of operation for drive-thru and walk-in clinics are available at www.saskatchewan.ca/drive-thru-vax.

A map of participating pharmacies across the province is available at www.saskatchewan.ca/covid19-pharmacies.  This online tool includes links to pharmacy booking websites and provides details on the vaccine brand being offered at each location.

Daily COVID-19 Statistics

There are 36 new cases of COVID-19 to report in Saskatchewan on July 9, bringing the provincial total to 49,198 cases.

The new cases are located in the following zones: Far North West, 4; Far North East, 4; North West, 3; North Central, 5; North East, 2; Saskatoon, 4; Regina, 5; South West, 4; and South East, 4.  One case is pending residence information. Fifteen cases were reassigned to the following zones: Far North East, 11; and North Central, 4.  Ten cases, which were Saskatchewan residents tested out-of-province, were added to the following zones: Far North West, 1; Far North East, 1; North West, 5; Saskatoon, 1; Central East, 1; and South Central, 1.

One new death was reported today in the 80+ age group from the North West zone.

Recoveries total 48,224 and 403 cases are considered active.

There are 61 people in hospital.  Fifty-one are receiving inpatient care: North West, 6; North Central, 6; Saskatoon, 20; Central West, 1; Central East, 1; Regina, 14; South Central, 1; and South East, 2.  Ten are in intensive care: North Central, 2; Saskatoon, 4; and Regina, 4.

The seven-day average of new COVID-19 case number is 45 (3.7 per 100,000).  A chart comparing today’s average to data collected over the past several months is available at https://dashboard.saskatchewan.ca/health-wellness/covid-19/seven-day-average-of-new-covid-cases.

There were 2,544 COVID-19 tests processed in Saskatchewan on July 8, 2021.

To date, 932,412 COVID-19 tests have been processed in Saskatchewan.  As of July 7, 2021, when other provincial and national numbers were available, Saskatchewan’s per capita rate was 784,733 tests performed per million population.  The national rate was 979,207.

In response to the outbreak at Hatchet Lake, rapid testing is being conducted to support case contact identification.  Data entry of those results into the provincial system has been delayed while staff work on the immediate outbreak response.  It is anticipated the case data entry will continue throughout the weekend. 

While Hatchet Lake falls under the jurisdiction of the Northern Inter-Tribal Health Agency, the SHA has reached out to offer assistance to the local health teams to support the outbreak response.  Currently, voluntary mass testing is underway as part of active case finding, vaccinations are being offered door-to-door, and local public health officials and community leaders are actively working together on communicating risk, preventative measures and the importance of vaccinations.  The Saskatchewan Public Safety Agency has also been engaged and is coordinating with the federal government in potentially securing further resources. 

There were 80 lineage results reported for Variants of Concern today.  Of the 7,667 VOCs with lineages identified by whole genome sequencing in Saskatchewan, 6,911 are Alpha (B.1.1.7), 398 are Gamma (P.1), 348 are Delta (B.1.617.2) and 10 are Beta (B.1.351).

Confirmed variant of concern cases may appear in both columns on the website, depending on testing for that case.  Adding the cases identified by screening and those that have received whole genome sequencing may result in double-counting individual cases.

Provincial COVID-19 statistics on the total number of cases among health care workers, breakdowns of total cases by source of infection, age, sex and region, total tests to date, per capita testing rate and current numbers of confirmed variants of concern can be found at http://www.saskatchewan.ca/covid19-cases.

Limit Transmission of Variants of Concern in your Community – Get Vaccinated

The number of confirmed cases of the Delta variant has increased significantly in the last two weeks.  The Delta variant is assumed to be 1.5 times more transmissible and twice as virulent as the Alpha variant.

Two doses of the COVID-19 vaccine are required for optimal protection against the Delta variant.  Residents are strongly encouraged to get their first and second doses as soon as possible.

Getting tested also assists the monitoring of active cases and variants of concern in the province.  Even if experiencing mild symptoms, stay home and seek a COVID-19 test.  COVID-19 testing is available to all residents.  You can receive a referral for COVID-19 testing through HealthLine 811 or a health care provider, and drive-thru testing sites are available without a referral seven days a week in Regina, Saskatoon, Yorkton and Prince Albert.  Information on symptoms to watch for and how to get tested is available at www.saskatchewan.ca/covid19-testing.

Saskatchewan’s Re-Opening Roadmap – All Public Health Measures to Be Lifted July 11

With more than 70 per cent of residents over the age of 12 having received their first dose of COVID-19 vaccine, the full implementation of Step 3 of the Re-Opening Roadmap will occur on Sunday, July 11. 

That means that as of Sunday, July 11, all public health orders will be removed.  This includes the removal of the province-wide mandatory masking order, and the removal of limits on events and gathering sizes.

For the guidance on Living with COVID-19, including the expectations around masking, information for businesses and workplaces, and the visitation requirements for acute care as well as long term care and personal care homes starting July 11, go to https://www.saskatchewan.ca/living-with-covid.

General COVID-19 Information

General public inquiries may be directed to COVID19@health.gov.sk.ca.

 

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Biosimilar mRNA Vaccines, Part 1: Regulatory Revolution! – The Center for Biosimilars

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The COVID-19 pandemic has brought a remarkable shift in how we will prevent infections and autoimmune disorders in the future. The nucleic acid vaccines, including messenger RNA (mRNA) and DNA vaccines, have been under development for decades, but there was no opportunity to test their safety and efficacy; vaccines may take years and decades to provide sufficient proof of safety and efficacy. Then came COVID-19, caused by the SARS-CoV-2 virus. Fast data collection became possible because the virus was so widespread. Even with small infection numbers (n = 150) among study populations that averaged about 30,000 to 40,000, it was clear that mRNA vaccine efficacy was surprisingly high: 95% or better. The FDA would have approved the use of the mRNA vaccine at even at 50% efficacy.

The safety of the mRNA vaccines was confirmed clearly in multiple studies across the globe. However, not all COVID-19 vaccines fared well. The third mRNA vaccine, by CureVac, failed because its developers chose not to follow the teachings of the common wisdom. mRNA vaccines work by introducing a harmless piece of the virus into the body and triggering an immune response that conditions the body to recognize and attack the true virus. Moderna and Pfizer–BioNTech vaccines use modified RNA (pseudouridine); CureVac chose not to modify the RNA, and its vaccine uses normal uridine. It produced lower levels of antibodies than the Moderna and Pfizer-BioNTech vaccines and was just 47% effective at preventing COVID-19 infection. Incidentally, the name Moderna comes from “modified RNA.”

The Chinese Sinopharm vaccine, a traditional inactivated virus vaccine, also failed. This failure brought great misery because the Chinese government had used this vaccine as a diplomacy tool, supplying billions of doses to developing countries. As of today, none of the non-mRNA COVID-19 vaccines have come close to the efficacy of the mRNA vaccines.

We have 2 mRNA vaccines approved under Emergency Use Authorization (BNT162b2, mRNA-1273/NAID), and I anticipate their full approval soon. Pfizer has filed for the modification of storage temperature, and Moderna has filed for the reduction of dose; the Pfizer dose is 30 mcg, and the Moderna dose, 100 mcg. There are now newer lipid nanoparticle (LNP) formulations that can provide better temperature stability allowing only refrigeration storage.

Incidentally, Moderna has permitted the use of its patented LNP technologies to any company. Although the challenges to overcome IP issues remain, the humanitarian considerations make these challenges manageable. The US government has proposed to remove patent exclusivity relating to the COVID-19 vaccines. This action will require EU cooperation that is yet to come. However, as a patent law practitioner, I am confident that we can make COVID-19 vaccines without any patent infringement that remains in our way. mRNA vaccines have been under development for decades, so much of the base technology is already in the public domain. Both Pfizer and Moderna have shared their clinical protocol, and that is a rare event, as these protocols cost millions to produce and billions to execute. No other vaccine developer has shared these protocols in public. The mRNA vaccine developers now have a clear understanding of the regulatory process required to approve new mRNA vaccines.

Regulatory Pathway

At the time of the enactment of the Biologics Price Competition and Innovation Act (BPCIA, 2010), there was no indication that the introduction of mRNA vaccines would create a dilemma for the FDA in deciding an appropriate regulatory pathway.

The FDA’s Center for Biologics Evaluation and Research (CBER) jurisdiction includes biological products such as prophylactic and therapeutic vaccines, whole blood and blood products, cellular products and exosomal preparations, gene therapies, tissue products, and live biotherapeutic agents. CBER also regulates selected drugs and devices used to test and manufacture our biological products. In keeping with that mission, product approval applications filed with CBER include 351(a) filings, which are for “standalone” or original products, rather than biosimilars (21 Code of Federal Regulations [CFR] 601.2). The biologics license application (BLA) is regulated under 21 CFR 600 – 680.

Many biological products are controlled by the Center for Drug Evaluation and Research (CDER), including biosimilar and interchangeable biologics. For example, in March 2020, insulin, glucagon, and human growth hormone regulated as drugs under the Food, Drug, and Cosmetic Act came into the CDER BLA program.

mRNA vaccines have a unique feature: They are manufactured chemically, not biologically, as are many other vaccines. As a result, the vaccine structure is completely known, unlike the therapeutic proteins. The variations in the secondary and tertiary structures and post-expression modifications require intensive evaluation of similarity to allow them a biosimilar status. A proposed biosimilar mRNA vaccine can provide a 100% match for a reference product sequence. Thus, mRNA vaccines are closer to generic chemical products than biological therapeutic proteins.

In my opinion, the traditional vaccines can stay within the jurisdiction of CBER, and the chemically synthesized vaccines be approved under BLA by CDER under the 351(k) filing where suitable.

Already, the FDA has issued a final guideline (February 2021) on the development of products for the treatment and prevention of COVID-19, which states:

“COVID-19 vaccine development may be accelerated based on knowledge gained from similar products manufactured with the same well-characterized platform technology, to the extent legally and scientifically permissible. Similarly, with appropriate justification, some aspects of manufacture and control may be based on the vaccine platform, and in some instances, reduce the need for product-specific data. Therefore, FDA recommends that vaccine manufacturers engage in early communications with [Office of Vaccines Research and Review] to discuss the type and extent of chemistry, manufacturing, and control information needed for development and licensure of their COVID-19 vaccine.”

This statement can be construed as pointing to the possibility of a biosimilar application filing for a licensed (BLA) product to meet all requirements of the BPCIA. If the sequence of a biosimilar mRNA vaccine matches a reference product sequence, then the need for extensive toxicology and efficacy testing can be reduced, on a case-by-case basis, depending on other factors of variation. In my earlier conversation with the FDA, I appreciated the broad encouragement I received to discuss the development plan in a Type B meeting first, where the possibilities of a modified 351(a) filing or a 351(k) filing for a biosimilar mRNA vaccine can be discussed; the 351(a) modified approach will be analogous to a 505(b)(2) new drug application under the FDC Act. I will keep my readers informed of any new indications from the FDA.

mRNA vaccines are now at the forefront of hundreds of possibilities, including preventing infections to preventing autoimmune disorders. Since the antigens focused on the design of mRNA vaccines cannot be patented, a biosimilar vaccine product may likely produce the product without any infringement issue. The testing proposal presented above will help expedite the approval of biosimilars without risking the safety and efficacy of biosimilar products.

For the first time, we have a scientific challenge to meet: how to classify mRNA vaccines as chemical drugs or as biosimilars rather than standalone biologics?

In contrast to chemically synthesized small molecular weight drugs, which have a well-defined structure and can be thoroughly characterized, biological products generally derived from living material (humans, animals, or microorganisms) are complex in structure and, thus, are usually not fully characterized. However, this last consideration does not apply to mRNA vaccines.

To promote the idea of creating a new category of products, biosimilar vaccines, I have filed a citizen petition to the FDA advising the agency on creating new guidance for this new class of biosimilar products. In my opinion, the agency will agree to many of my suggestions because the issue of structural similarity with a reference product is no longer an issue. Preclinical toxicology studies can be waived based on in vitro and situ studies, requiring only comparable antibody production in animal species. The immunogenicity—stimulation of immune response—is not a significant issue because vaccines are supposed to be antigenic. A limited trial in animal species capable of showing antibody response that is comparable to findings with the reference mRNA vaccine will suffice to establish equivalent safety with the reference product.

I have also developed several mRNA vaccines, including COVID-19, flu, HPV, HIV, and tuberculosis, that are under advanced stages of development across the globe, including one with a biosimilar status. Today, the world needs about 8 billion doses of COVID-19 vaccines that work. I have concluded that we can make 1 billion doses using 30 L bioreactors in 6 months with our cost of goods not exceeding $0.50 per dose in bulk and $0.90 in final packaging if the vaccine is manufactured in the United States; the costs can be lower if manufactured in developing countries. For example, the cost of Moderna single dose is $32 to $37, and Pfizer’s, $22 in final packaging. I can confirm these costs of manufacturing that make the commercial manufacturing of COVID-19 vaccines a highly profitable project.

While there is an excess of COVID-19 vaccine in the United States, the rest of the world is still starving for it. The WHO has also told me that the world needs 8 billion doses of COVID-19 vaccines and that they will be very proactive if anyone can supply the mRNA vaccines; the trust in all other vaccines has declined. This is a remarkable business opportunity for many companies since the capital expenditures (CAPEX) and operating expenditures (OPEX) are very small. In my next article on the topic, I will provide details of strategies to take the mRNA vaccines to market fast and reduce CAPEX and OPEX significantly. I want to enable newcomers to appreciate that mRNA technology will revolutionize health care, and there are many opportunities to join this revolution.

Summary

mRNA vaccines are chemically derived and have fixed chemical structures; it is possible to fully replicate a reference product sequence, reducing the burden of proving biosimilarity required for therapeutic proteins. The FDA has already suggested a new pathway for mRNA vaccines, but this path will only come into being when enough companies join in taking steps toward this strategy.

Watch for the second article in this series: Biosimilar mRNA Vaccines—Fast-to-Market Strategies.

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Majority of COVID-19 cases at large public events were among vaccinated Americans: CDC study – CTV News

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A new study by the U.S. Centers for Disease Control and Prevention showed that three-quarters of individuals who became infected with COVID-19 at public events in a Massachusetts county had been fully vaccinated.

The study, published on Friday, showed that three-quarters of those infected were fully vaccinated, suggesting the Delta variant of the virus is highly contagious.

A separate CDC internal document, first reported by the Washington Post on Friday, described the Delta variant as being as transmissible as chickenpox and cautioned it could cause severe disease.

The new study’s authors recommended that local health authorities consider requiring masks in indoor public settings regardless of vaccination status or the number of coronavirus cases in the community.

The study identified 469 people with COVID-19, 74% of whom were fully vaccinated, following large public events in the state’s Barnstable County. Testing identified the Delta variant in 90% of virus specimens from 133 people.

The viral load was similar in people who were fully vaccinated and those who were unvaccinated, the CDC said.

High viral loads suggest an increased risk of transmission and raised concern that, unlike with other variants, vaccinated people infected with Delta can transmit the virus, it said.

The finding of the report “is concerning and was a pivotal discovery leading to CDC’s updated mask recommendation,” CDC director Rochelle Walensky said in a statement.

On Tuesday, the CDC reversed course on guidance for mask wearing, calling for their use in areas where cases are surging as a precaution against the possible transmission of the virus by fully vaccinated people.

“The masking recommendation was updated to ensure the vaccinated public would not unknowingly transmit virus to others, including their unvaccinated or immunocompromised loved ones,” Walensky said in a statement.

Reporting by Manas Mishra in Bengaluru; Editing by Howard Goller

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Obstetrician groups recommend COVID vaccine during pregnancy – Burnaby Now

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Two leading obstetricians’ groups on Friday recommended COVID-19 shots for all pregnant women, citing concerns over rising cases and low vaccination rates.

The American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine said vaccinations in tens of thousands of pregnant women over the past several months have shown the shots are safe and effective during pregnancy.

COVID-19 during pregnancy increases risks for severe complications and can also increase chances for preterm birth. U.S. government data show only about 16% of pregnant women have received one or more doses of the COVID-19 vaccine.

The two groups had previously said pregnant people shouldn’t be excluded from vaccination but stopped short of endorsing the shots.

The president of the OB-GYN group, Dr. Martin Tucker, said in a statement that doctors should enthusiastically recommend the shots to their patients.

Dr. Emily Miller, obstetrics chief at Northwestern Medicine in Chicago, said she hopes the new recommendation “will help pregnant people feel more confident in their decision to get the COVID-19 vaccine as soon as possible.”

Miller is a member of the maternal-fetal medicine group’s COVID-19 task force.

Pregnant women weren’t included in studies that led to emergency authorization of the vaccines. Experts including the federal Centers for Disease Control and Prevention have not discouraged vaccination during pregnancy and have said available safety information is reassuring.

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

The Associated Press

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