Daily Archives: April 2, 2021

EmployBridge chief workforce analyst Joanie Bily provides insight into the March jobs report.

Johnson & Johnson Covid-19 vaccine batch was discarded after not meeting specifications and quality standards at an Emergent BioSolutions plant.

The Labor Department is expected to say the U.S. economy added 647,000new nonfarm jobs last month, up from a much stronger-than-expected increase of 379,000jobs in February

The IRS and Treasury Department on Thursday night said the administration had disbursed 130 million economic impact payments worth about $335 billion as it prepares to send a large set to Social Security and other federal beneficiaries.

With Covid cases on the decline, many restaurants are opening back up to full capacity. Yet owners say they are struggling to hire new staff to keep up with demand.

U.S. manufacturers are the strongest they've been in 37 years, here's why...

TheIRSwill start issuingtaxrefunds in May to Americans who already filed their returns but are eligible to take advantage of a new break on unemployment benefits.

Techstocks got off to astrong start in the second quarter even asweekly jobless claims rose.

Federal officials are warning Americans of a fake post-vaccine survey scammers are sending around in an effort to harvest personal information.

Mississippi Governor Tate Reeves on the idea of the government requiring a passport to move freely within the country.

San Diego Unified School District parent Bonnie Jimenez discusses migrant students having access to in-person teaching while her daughter is still taking virtual classes.

NASAhas announced that it will invest more than $45 million in365 proposals from American small businesses as part of the agency'sSmall Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR)programs.

Steinbrenner Racing president and CEO George Steinbrenner IV discusses his outlook for the 2021 MLB season amid the coronavirus pandemic.

The company at the center ofquality problemsthat led Johnson & Johnson to discard an unknown amount of its coronavirus vaccine has a string of citations from U.S. health officials for quality control problems.

The quarter begins with reports on jobless claims and manufacturing

- A group of investors managing a collective $3 trillion in assets will call on operators of nursing homes to improve pay and working standards for care workers, noting the "devastating outcomes" of the COVID-19 pandemic on the industry.

American actor Dan Lauria shares his expectations for Broadway's post-pandemic reopening.

A dosage mix-up at a Baltimore production facility, which ruined about 15 million doses of Johnson & Johnsons COVID vaccine, has prompted the U.S. Food and Drug Administration to delay shipments of the vaccine.

A spokesperson for the company told FOX Business that selectoffices in the U.S. will begin reopening atlimited capacity based on specific criteria, including vaccine availability and downward trends in COVID-19 cases.

Florida Attorney General Ashley Moody stressed the importance of restarting the cruise industry, saying she doesn't want to see a loss of revenue that is so vital to the states success.

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Coronavirus | Category | Fox Business

For Immediate Release: April 01, 2021

Today, the U.S. Food and Drug Administration announced two revisions regarding the number of doses per vial available for the Moderna COVID-19 Vaccine. The first revision clarifies the number of doses per vial for the vials that are currently available, in that the maximum number of extractable doses is 11, with a range of 10-11 doses. The second revision authorizes the availability of an additional multi-dose vial in which each vial contains a maximum of 15 doses, with a range of 13-15 doses that can potentially be extracted.

Both of these revisions positively impact the supply of Moderna COVID-19 Vaccine, which will help provide more vaccine doses to communities and allow shots to get into arms more quickly. Ultimately, more vaccines getting to the public in a timely manner should help bring an end to the pandemic more rapidly, said Peter Marks, M.D., Ph.D., director of the FDAs Center for Biologics Evaluation and Research.

Depending on the type of syringes and needles used to extract each dose, there may not be sufficient volume to extract more than 10 doses from the vial containing a maximum of 11 doses or more than 13 doses from the vial containing a maximum of 15 doses.

To support these changes to the emergency use authorization, the FDA evaluated data showing the number of doses that could be extracted from the vials and on the fill volumes for both vials that were submitted by ModernaTX, Inc. The Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) and Prescribing Information have been revised to reflect the new information and are intended to help frontline workers administering COVID-19 vaccines understand the number of doses that can potentially be extracted per vial.

Because the Moderna COVID-19 Vaccine does not contain preservative, any further remaining product that does not constitute a full dose should not be pooled from multiple vials to create one full dose. If one vial becomes contaminated during use, pooling doses from multiple vials can spread contamination to other vials. Use of contaminated vials may cause serious bacterial infections in vaccinated individuals. The updated information in the revised Fact Sheet for Vaccination Providers and Prescribing Information provides instructions to not pool vaccine from multiple vials.

The dosing regimen remains unchanged; the vaccine is administered as a two-dose series, 0.5 mL each dose, one month apart.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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04/01/2021

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Coronavirus (COVID-19) Update: FDA Makes Two Revisions to Moderna COVID-19 Vaccine Emergency Use Authorization to Help Increase the Number of Vaccine...

By: Francisco R. Velzquez, M.D., S.M.

Organisms in general, be it humans, plants, insects, bacteria, or viruses, undergo genetic mutations which can be beneficial or detrimental. Although viruses are not technically alive, these also mutate and evolve as they infect a hosts cell, replicate and move on to another cell or a new host. The process by which a virus spreads is what we call transmission. There are differences in the rates of mutations amongst different types of viruses. As an example, the SARS-CoV-2 coronavirus which causes the clinical entity we know as COVID-19 mutates approximately every 11-15 days. That is about half of the rate of influenza (flu) and about a quarter of the HIV rates. Mutations generate variability within a population, which allows natural selection to amplify traits that are beneficial, in this case, to the viral particle, as viruses are not considered organisms per-se.

We know the coronavirus currently has 12,700 identified mutations, 12 main types of the virus (identified as 19 A, the original type, through 20 J), five strains and almost 4000 variants. The strains are known as L, the original strain, which mutated into the S strain followed by V and G (further mutating into GR, GH and GV, and several infrequent mutations collectively grouped together as O). The G strains are now the dominant strain around the world. SARS-CoV-2 variants with spike (S)-protein D614G mutations have become the most common variant. It is so named because one amino acid is changed from a D (aspartate) to a G (glycine) at position number 614 of the viral spike proteins. The spike protein mediates the binding to the target receptors and the fusion to the human cell membrane. The S protein extends from the viral membrane giving the virus surface a crown-like appearance, for which the virus is named; corona is crown in Latin. Most of the variants of concern contain mutations in the receptor-binding domain (RBD). It seems these mutations are responsible for increased viral infectivity, virulence, and immune evasion potency. It is known that the RBD is involved in viral recognition and cell receptor binding and interaction, thus any structural changes seem to be directly related to viral transmissibility and virulence. It has also been identified in numerous studies that antibodies developed against the RBD have been found to have maximum potency against the SARS-CoV-2.

It all starts in the coronavirus RNA genome, which is composed of 30,000 nucleotides, the basic structural unit of nucleic acids. The best way to think about it is as an alphabet of 30,000 letters that spell the sequences for 29 genes. The virus itself is a coil of genetic material in a protein shell with an outer envelope most of the time. The virus binds to a human target cell receptor, injects its genetic material, and takes over the cell, turning into a virus replicating factory. As it replicates, mutations can take place and either help or compromise the virus. Many of the identified mutations are inconsequential as these do not change the biology of the virus. Mutations are passed down through lineage, best described as a branch in the family tree. A group of coronaviruses that have the same inherited set of very distinctive mutations is called a variant. The lineage becomes known as a strain, and in this specific example, COVID-19 is caused by a coronavirus strain known as SARS-CoV-2. Through the course of the pandemic, we have identified several variants globally, five of which are of concern as the strains are associated with higher transmission rates that may impact the effectiveness of vaccine and therapy, and it seems increased mortality may be associated with at least one variant. More recently there have been several variants identified in the United States that share some mutations with the more aggressive variants initially identified in other countries.

The first step in understanding the variants and the impact these have in infection, reinfection and possible effects on vaccines and treatments is knowing the mutations. Although there are thousands of mutations for the most part, thus far, seven of those are the most critical to know.

The D614G Spike mutation was the first mutation of concern identified in China early in the pandemic. This mutation quickly spread around the world allowing the mutated viruses to rapidly replace strains without the mutation. Although it seemed to increase the infectiousness, it was not associated with more severe disease or reduced vaccine effectiveness.

The first variant-associated mutation seen in Europe is known as A222V, identified in the B.1.177 (20A.EU1) variant that originated in Spain and dominated the European landscape for months. We do not hear much about it, because it has not been associated with increased transmission.

More of concern are the next five mutations identified. First is the N501Y Spike mutation which has been identified in at least three variants of concern. Found at the tip of the Spike protein, this mutation seems to cause a tighter thus more effective fit to the human cell receptors.

The E484K Spike mutation is of significant concern as it has been identified not only in three of the global variants, but also in the newly described American variants. It has been observed in vitro that this mutation alters the shape of the proteins in the viral spike which can potentially mask the antigenic portion from antibodies. There has been much speculation as whether this mutation may impact the effectiveness of monoclonal antibody treatments and cause reinfection in some patients.

The next mutation, although infrequent in the United States, has been associated with many cases in California. L452R has triggered the emergence of numerous global variants and is present in the two recently identified California variants which also carry other mutations. The L452R mutation might enhance the interaction between virus and host cell, which in turn may significantly increase viral transmission and virulence. It may also reduce the virus-neutralizing ability of antibodies specifically targeting the spike RBD.

The sixth is the K417N/T mutation located on the tip of the spike protein, an area important to the antibody recognition process. In some experiments the K417N/T mutation has been associated with decreased antibody recognition and possible resistance to some antibodies. The possibility of a more effective virus/cell binding process has also been described.

More recently the Q677 mutation has been described in at least seven lineages initially identified in Louisiana and New Mexico. Its now in seven states, mainly in the south central and southeast United States. This mutation is four amino acids away from the S1/S2 cleavage site, an area where other mutations have been identified in the more infectious strains. It is unclear currently whether this mutation increases transmission rates.

The centers for Disease Control have defined three different levels of threat associated with variants. These are variants of interest (B.1.526, B.1.525 and P.2), variants of concern (B.1.1.7, P.1, B.1.351, B.1.427 and B.1.429), and variants of high consequence. In the U.S. we have identified the first two categories only. For the variants of concern there is evidence of increased transmissibility, more severe disease and reduced therapeutic effectiveness. Currently, globally-identified variants have been detected in multiple states. First identified in the United Kingdom is the variant known as B.1.1.7, now present in at least 90 countries and 51 states including Washington. This variant accumulated a high number of mutations including several in the spike protein. Of the 17 identified, the most notable is the N501Y mutation which has been found to help the virus form a tighter attachment to the ACE2 receptors. This variant is approximately 50% more infectious than the wild type of virus and is estimated to be doubling in the U.S. every 10 days.

Just as the B.1.1.7 variant was being identified, another variant with the same type of N501Y mutation was identified in South Africa. This variant is known as B.1.351 and contains additional mutations such as the K417N, and of more concern the E484K mutation. The latter has been identified in 48 countries and 30 states including Washington. In vitro studies have suggested a potential for a blunted immune response, and a small impact on vaccine efficacy.

A variant that originated in Brazil was first reported in Japan, as it was identified on four people screened upon arrival at an airport outside of Tokyo. It is postulated that the travelers acquired the variant known as P.1 while in Brazil where the lineage is traced back to the city of Manaus, the largest city on the Amazon region. This variant has 17 unique mutations in the spike protein that include the N501Y, E484K and K417N previously discussed. It has been identified in at least 25 countries and 22 states, including Washington. Of particular concern is the anecdotal reports of reinfection in people who had recovered from disease.

Several other variants have been identified in the U.S. over the past several months. One of these variants with the L452R mutation was identified in California and is considered a variant of concern. The variant designated as CAL.20C has two forms: the B.1.427 and B.1.429. It is believed to cause a stronger attachment that may prevent neutralizing antibodies from interfering with the attachment process. Additional work is needed in determining the impact this has in transmissibility, and disease severity.

The B.1.526 and B.1.525 Variants identified in New York and traced back to Washington Heights, a Manhattan neighborhood, the B.1.526 variant has two types: one with the E484K spike mutation which may blunt the antibody response and another with the S477N mutation that may increase the effectiveness of the attachment process. The E484K mutation is also present in the Brazilian and South African variants. These, in addition to the P.2 identified in Brazil, are currently classified as variants of interest.

In the Midwest, specifically in Columbus, Ohio, two novel SARS-CoV-2 clade 20G variants have been identified. The predominant variant has several mutations, including the Q677H and has been identified in several states in the upper Midwest. It is referred to as the Midwest variant. Subsequently, a second variant with the S N501Y mutation, which is a marker of the B.1.1.7, but lacking all other mutations associated with that strain has been identified. This mutation has also been associated with the South African variant. It will be important to further determine what impact these variants will have in the overall pandemic pattern.

It is important to remember that what most of these variants have in common is a more effective transmission pattern, which has been associated with a surge in infections in various areas of the world. In addition, some data suggest that increased morbidity and perhaps mortality can be associated with some of the variants. The impact on treatment and vaccines is still being determined, although preliminary data points to minimal impact on vaccine efficacy. Moreover, vaccine manufacturers have significant capabilities in the reformulation of vaccines.

We also know the transmission mode is the same as with the wild-type (unchanged) coronavirus, thus preventing infection should follow a similar public health guidance: facial coverings, social distancing, avoiding gatherings, and practicing appropriate hygiene and sanitation. These simple rules along with increased immunization and appropriate levels of testing continue to be the key pillars in our management of the pandemic.

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Coronavirus Mutations and Variants: What Does It Mean? - Spokane Regional Health

DETROIT The number of confirmed cases of the coronavirus (COVID-19) in Michigan has risen to 678,295 as of Thursday, including 16,141 deaths, state officials report.

Thursdays update includes a total of 6,036 new cases and 49 additional deaths, including 33 from a vital records review. On Wednesday, the state reported 672,259 total cases and 16,092 deaths.

Testing has been steady around 35,000 diagnostic tests reported per day on average, with the 7-day positive rate above 13.5% as of Thursday, the highest since early December. The state has reported an up-tick in hospitalizations over the last several weeks.

Related: Michigan COVID hospitalizations: Concerns grow as more younger adults are in ICU

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Michigans 7-day moving average for daily cases was 5,061 on Thursday -- the highest since December. The 7-day death average was 26 on Thursday and has been flat for several weeks. The states fatality rate is 2.4%. The state also reports active cases, which were listed at 94,500 on Thursday -- the highest its been since mid-January.

More than 569,000 have recovered from the virus in Michigan.

Michigan has reported more than 4.4 million doses of the COVID-19 vaccine administered as of Wednesday, with 34.5% of residents having received at least one dose.

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More: Whitmer says Michigan plans to combat rising COVID cases with masks, vaccines -- not new restrictions

According to Johns Hopkins University, more than 30.5 million cases have been reported in the U.S., with more than 553,000 deaths reported from the virus.

Worldwide, more than 129.7 million people have been confirmed infected and more than 2.8 million have died. More than 72 million have recovered, according to Johns Hopkins University. The true numbers are certainly much higher, because of limited testing, different ways nations count the dead and deliberate under-reporting by some governments.

Michigan COVID-19 vaccinations: How to find appointments, info on phases

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Coronavirus headlines:

VIEW: Tracking Michigan COVID-19 vaccine doses

VIEW: Tracking coronavirus cases, outbreaks in Michigan schools

Gov. Gretchen Whitmer released a statement Tuesday after White House officials announced that there will increase COVID-19 vaccine doses available for Michigan starting next week.

According to a press release, next weeks shipment will increase by 66,020 bringing the total number of doses to 620,040 -- a weekly record for the state. Officials said the allocation includes 147,800 doses of the single-dose Johnson & Johnson vaccine.

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This comes after Whitmer recently requested for more vaccines as the state is seeing a rise in COVID numbers.

The CDC said that Michigan is leading the country in new cases of COVID-19 per population.

On Tuesday, officials reported 5,177 new COVID cases and 48 additional deaths, including 20 from a Vital Records review. On Monday, the state reported 660,771 total cases and 16,034 deaths.

Local 4s Dr. Frank McGeorge said hes seen a very clear increase in COVID patients at the hospital where he works.

Many of them need to be hospitalized. I would honestly say, this feels worse to me here in Southeast Michigan than it was during the wave that started in November. Now, the most concerning trend is the number of middle-aged people with severe COVID, McGeorge said.

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All Detroiters 16 and older are now eligible for a COVID-19 vaccine, the city announced Monday.

Any Detroit resident age 16 or older can now call to schedule an appointment to be vaccinated at the TCF Center.

Appointments can be made by calling 313-230-0505. Anyone living outside of the city of Detroit, but reporting to work each day in the city, also are eligible to schedule an appointment.

Johnson & Johnson vaccine site opened at Northwest Activities Center 9-1 this Saturday.

Chief Public Health Officer Denise Fair also announced that the Detroit Health Department has been informed it will receive its first allocation of Johnson and Johnson vaccine this week. Detroiters wanting the one dose J&J vaccine can call 313-230-0505 for an appointment to receive at the Northwest Activities Center, located at 18100 Meyers from 9-1 this Saturday.

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The state of Michigan announced Friday that all residents age 16 and up will become eligible for the COVID-19 vaccine on April 5, nearly a month before the May 1 date pledged by President Joe Biden.

People age 16 to 49 with certain medical conditions or disabilities will qualify starting March 22, when 50- to 64-year-olds can begin getting shots under a previous announcement. Two days later, March 24, a federally selected regional mass vaccination site will open at Detroits Ford Field to administer an additional 6,000 doses a day for two months.

Learn more here.

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MORE: Michigans updated COVID-19 vaccination schedule: Who is eligible and when

The Michigan Department of Health and Human Services announced that the first case of the COVID-19 variant B.1.351 has been identified in a child in Jackson County.

The health department did not say how the boy was infected but a case investigation is underway to determine close contacts and if there are additional cases associated.

This new variant was originally detected in South Africa in October 2020 and shares some mutations with the B117 variant. The first case of the B117 variant -- originally detected in the United Kingdom -- was identified in Washtenaw County.

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The state of Michigan has loosened its COVID-19 restrictions on bars and restaurants, including the capacity limit and nightly curfew.

On Tuesday, March 2, Gov. Gretchen Whitmer and the Michigan Department of Health and Human Services announced the restrictions on indoor dining have been revised.

Starting Friday, March 5, Michigan restaurants and bars will be allowed to fill up to 50% capacity, with a maximum of 100 people, according to the state.

Im proud that we are able to take this positive step without compromising public health, Whitmer said.

Since Feb. 1, restaurants had been capped at 25% capacity. From mid-November through the end of January, no indoor dining was allowed at bars or restaurants.

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The number of the confirmed cases of a more contagious COVID-19 variant in Michigan increased by more than 100 this week, suggesting there is undetected spread in the community.

Dr. Joneigh Khaldun, the chief medical director for the Michigan Department of Health and Human Services, said the state has confirmed 422 cases of the COVID-19 B117 variant.

That number increased from 314 cases identified as of six days prior (Feb. 24).

Through a partnership with SMART, Macomb County is offering a new vaccination location in Sterling Heights.

The vaccination site is at the Sterling Heights Senior Center on Utica Road, between Schoenherr and Van Dyke roads.

Appointments are required. Eligible residents and workers can call the SMART Macomb Vaccine line at 586-421-6579.

Wayne County announced it will open several vaccination clinics for residents 65 and older.

According to county Executive Warren Evans, the vaccination clinics will begin Feb. 23.

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Im pleased Wayne County is now in a position to begin vaccinating seniors, Evans said. I know everyone is eager to safely get back to normal. Our team is working hard to ensure all of our residents can get their COVID shot as quickly as the vaccine is available.

There are no walk-up appointments and seniors must make an appointment by calling the number for the site in their communities.

The full list of clinics and how to register can be found here.

Michigan COVID-19 daily reported cases since March 1:

March 1 -- 785 new cases

March 2 -- 1,067 new cases

March 3 -- 1,536 new cases

March 4 -- 1,526 new cases

March 5 -- 1,486 new cases

March 6 -- 1,289 new cases

March 7 -- 980 new cases

March 8 -- 980 new cases

March 9 -- 954 new cases

March 10 -- 2,316 new cases

March 11 -- 2,091 new cases

March 12 -- 2,403 new cases

March 13 -- 1,659 new cases

March 14 -- 1,571 new cases

March 15 -- 1,572 new cases

March 16 -- 2,048 new cases

March 17 -- 3,164 new cases

March 18 -- 2,629 new cases

March 19 -- 3,730 new cases

March 20 -- 2,660 new cases

March 21 -- 2,400 new cases

March 22 -- 2,401 new cases

March 23 -- 3,579 new cases

March 24 -- 4,454 new cases

March 25 -- 5,224 new cases

March 26 -- 5,030 new cases

March 27 -- 4,670 new cases

March 28 -- 4,101 new cases

March 29 -- 4,101 new cases

March 30 -- 5,177 new cases

March 31 -- 6,311 new cases

April 1 -- 6,036 new cases

Michigan COVID-19 daily reported deaths since March 1:

March 1 -- 6 new deaths

March 2 -- 24 new deaths (12 from vital records)

March 3 -- 5 new deaths

March 4 -- 37 new deaths (29 from vital records)

March 5 -- 10 new deaths

March 6 -- 56 new deaths (48 from vital records)

March 7 -- 2 new deaths

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Coronavirus in Michigan: Heres what to know April 2, 2021 - WDIV ClickOnDetroit

For Immediate Release: March 31, 2021

Following recent U.S. Food and Drug Administration actions to support test development, the FDA took swift action this week to get more tests for screening asymptomatic individuals on the market. Today, the agency authorized several tests for over-the-counter (OTC) use without a prescription when used for serial screening. In addition to the tests authorized for OTC use, one serial screening test was authorized for use in a point-of-care (POC) setting without a prescription, and an additional screening test was authorized for POC use with a prescription. The addition of the OTC and POC tests for screening will give schools, workplaces, communities and others several options for serial screening tests that are accurate and reliable. These authorizations follow the FDAs recent actions to advance OTC and other screening test development.

Screening testing, especially with the over-the-counter tests authorized today, is an important part of the countrys pandemic responsemany schools, workplaces, communities, and other entities are setting up testing programs to quickly screen for COVID-19. With the FDAs authorization of multiple tests, the public can be assured these tests have met our scientific standards for emergency use authorization. As weve said all along, if its a good test, well authorize it, said Jeff Shuren, M.D., J.D., director of the FDAs Center for Devices and Radiological Health. The FDA has taken many steps to support test development throughout the pandemic, including authorizing tests quickly, offering many avenues for test developers to work with us to get their tests on the market, if shown to be accurate and reliable, and issuing enforcement policies for COVID-19 tests. As the pandemic has progressed, we have worked with test developers wishing to add screening claims.

In total, the FDA has authorized three tests with serial screening claims (testing asymptomatic individuals multiple times on a routine basis). Specific tests authorized this week:

These tests had been previously authorized by the agency (some under different names) to test those with COVID-19 symptoms, but the actions this week authorize testing of asymptomatic individuals when used for serial testing.

These authorizations follow the agencys multiple steps to streamline the process for test developers interested in authorization for screening with serial testing to increase consumer access to testing, as well as information the FDA has issued to help schools, workplaces, communities, and others establish screening programs.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nations food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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03/31/2021

Originally posted here:

Coronavirus (COVID-19) Update: FDA Continues to Advance Over-the Counter and Other Screening Test Development - FDA.gov