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ECDC launches new weekly COVID-19 surveillance report

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Trends in notification rates and deaths

Based on data available to ECDC on 20 May 2020, 29 out of 31 countries (EU/EEA countries and the UK) showed consistently decreasing trends in COVID-19 14-day case notification rates compared to peaks that were observed 13–49 days earlier. The average rate for the EU/EEA and the UK was 68% lower than at the peak on 9 April 2020. There have been slight recent increases in 14-day notification rates in two countries.

Many countries are facing challenges in collecting and submitting reliable syndromic and virological data from primary care sentinel surveillance for COVID-19 using the systems established for influenza. All countries that reported data observed decreasing trends in SARS-CoV-2 positivity among individuals with respiratory symptoms.

The number of countries reporting moderate to extremely high excess all-cause mortality to EuroMOMO is decreasing. All-cause excess mortality is an objective measure of the pandemic’s impact, particularly during periods when competing drivers of excess mortality (influenza and high/low temperatures) are largely absent.

Risk of severe outcome

We estimate that overall 35% of COVID-19 cases to date in the EU/EEA and the UK were hospitalised. Among hospitalised patients, 9% required ICU and/or respiratory support and 21% died, although there is considerable variation between countries.

The latest pooled analysis of data from countries participating in the EuroMOMO network showed all-cause excess mortality primarily affecting people aged 65 years and above, but also those aged 15–64 years.

The risk of hospitalisation increased rapidly with age (from 30 years of age); the risk of death increased from 60 years of age. Hospitalised cases aged 70 years and above were less likely to be admitted to ICU or to receive mechanical respiratory support. Older males were particularly affected, being more likely than females of the same age to be hospitalised, require ICU/respiratory support, and die. The sex-difference in these severe outcomes increased with age.

Limitations

COVID-19 surveillance data reported so far by the EU/EEA and the UK provide relevant information for public health policymakers. However, further improvements are needed to reliably estimate indicators such as intensity, geographical spread, severity and impact of the disease. These can be obtained by establishing or strengthening population-based surveillance systems.

The numbers of reported cases and deaths can be influenced by testing policies, the way in which deaths are defined, and the settings included in death reporting. All these factors can affect within-country trends and make it difficult to directly compare countries.

Source: https://www.ecdc.europa.eu/en/news-events/ecdc-launches-new-weekly-covid-19-surveillance-report

Biotechnology

Enerkon (ENKS) Appoints AJSH and Co. Inc. a PCOAB firm with Maryland office in USA, as Auditor for 2018-19-20 and Q1 21 – in addition to the appointment of Berkowitz Pollack Brant (BPB) As Senior Advising CPA Firm for Up List Plans

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New York, New York, April 21, 2021 – OTC PR WIRE – Enerkon Solar International (OTC Pink: ENKS) announces today the appointment of AJSH and Co. Inc.  a PCOAB firm with Maryland office in USA, as Auditor for 2018-19-20 and Q1 21 – in addition to the appointment of Berkowitz Pollack Brant (BPB) As Senior Advising CPA Firm for Up List Plans.

Enerkon Solar International Inc (ENKS) Chairman Mr. Benjamin Ballout Stated: “Today, ENKS Appointed AJSH and Co. Inc.  a PCOAB firm with Maryland office in USA, as Audit Firm for 2018-19-20 and Q1 21 – whereby the Engagement agreement was signed by all parties and started as of today in addition we appointment the Firm Berkowitz Pollack Brant (BPB) As Senior Advising CPA Firm for Up List to Plans as of this afternoon.”

“Enerkon looks forward to success with regulatory agencies and Market Up List to NASDAQ – including the FDA as to the EUA Application for the SARS2- COVID19 15 Sec Insta Test (Patent Owned by Graphene Leaders Canada and Distributed by KrowdX of Canada –) CO sales with our 100% wholly owned Corporate subsidiary Coviklear Holdings Intl., Lt (UK) and others interlocutors”

“We look forward to a timely Audit completion over the coming period and advisory support for up listing”

Mr. Ballout continued: “Lastly, our March 31 Quarterly report will be posted within about 10 days, with Positive Earnings and Asset Growth, in line for the last 4 years averages and we shall announce the progress of our various interactions with the Governments of Ukraine, Libya and other countries, covering the next quarter plans and operations”

“Upon Up List in the coming period, we will hire a professional IR/PR Firm to gain exposure of the company with the Investment community, since we have never actively promoted the company officially, over the past 4 years and therefore the PPS and Valuation in our opinion, does not reflect the actual Valuation of the company or the correct PPS valuation, due to the OTC Market Conditions and again, the main reason for our Up List Plans.

“A Convertible Preferred Share Exchange may also be offered to Shareholders, which will include an 8% Dividend, in cash or kind and the effect of this conversion, will be a further contraction of outstanding shares / float – making market manipulation / shorting more difficult and giving a better PPS and valuation (Market Cap) to the Company as it deserves based on fundamentals”

The foregoing statements are forward-looking statements, and as such, they may or may not reflect the results which could transpire in the future which should be negative or not transpire at all due to circumstances or other reasons and investors, shareholders, or others should not rely on these forward-looking statements to ascertain any value if any of ENKS or to make any investment decisions and to take note that this is not an offer to buy or sell securities or an endorsement of ENKS for investment purposes as all investment carry a risk of loss sometimes a total loss of your investment in Micro cap shares markets or any market and therefore such statements or plans should not be relied upon for any business decisions of any kind – Approval and permissions required by federal regulations may or may not be approved and if not approved may result in the loss of all value and all investments in products requiring such regulatory permissions to market and sell. These statements are made as forward-looking statements for educational purposes only in accordance with the rules and regulations which pertain to the same.

Enerkon Solar International Inc.
www.enerkoninternational.com
info@enerkoninternational.com

New HQ Address in New York at:
Enerkon Solar International Inc
477 Madison Avenue
New York, NY 10022 USA

Tel. +1 (877) 573-7797
Tel. +1 (718) 709-7889

.

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Source: https://otcprwire.com/enerkon-enks-appoints-ajsh-and-co-inc-a-pcoab-firm-with-maryland-office-in-usa-as-auditor-for-2018-19-20-and-q1-21-in-addition-to-the-appointment-of-berkowitz-pollack-brant-bpb-as-senior-advi/

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FDA Inspection Finds Numerous Problems At Facility Intended To Make J&J Vaccine

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The Emergent BioSolutions Bayview Campus plant in Baltimore has stopped producing vaccine material following an FDA inspection that found numerous problems. The plant was slated to become part of the Johnson & Johnson COVID-19 vaccine production process. Tasos Katopodis/Getty Images hide caption

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Tasos Katopodis/Getty Images

Peeling paint. Cracked buckets. Employees dragging unsealed bags of medical waste. Procedures ignored. Inadequately trained staff.

All of these were problems noted by U.S. Food and Drug Administration inspectors at the Emergent BioSolutions factory in Baltimore – a facility that is intended to produce materials for the Johnson & Johnson COVID-19 vaccine. That plan is on hold, following a problem last month with a batch of a vaccine ingredient there, and now a range of documented issues at the facility.

The Emergent factory does not yet have FDA authorization to be part of the coronavirus vaccine supply chain, but was ramping up to be.

The FDA initiated an inspection of the company’s factory in Baltimore’s Bayview neighborhood on April 12. Four days later, the agency asked Emergent to stop manufacturing any new material at the facility, and to quarantine all existing vaccine substance already made there. The company complied, pending results of the inspection and any necessary remediation.

The results of that inspection were released Wednesday by the FDA, and they aren’t pretty. The FDA’s inspection report listed several troubling observations from visits to the facility and its review of video footage.

The inspection found that Emergent had not thoroughly examined what had led to the documented cross-contamination episode in March, and “did not include a thorough review of personnel movements in and around the facility as a potential source of contamination.”

“There is no assurance that other batches have not been subject to cross-contamination,” the report stated.

Other observations included:

  • The factory was not maintained in a clean and sanitary condition. Equipment wasn’t cleaned and maintained appropriately.
  • Procedures to prevent cross-contamination weren’t followed. It noted several instances of employees mishandling unsealed bags of special medical waste. Employees were also seen taking off outer protective garments on the warehouse floor where raw materials were staged for manufacturing.
  • Components and containers were not handled or stored in a manner to prevent contamination.
  • Inadequate written procedures to assure that drugs manufactured have the identity, strength, quality and purity they should.
  • Employees were not trained in the specific operation they performed or in current best practices related to their job function. Inspectors found Emergent had failed to adequately train personnel to prevent cross-contamination between products it was making for different, unnamed clients – presumably Johnson & Johnson and AstraZeneca.
  • It noted peeling floors and rough surfaces in sampling rooms and elsewhere, which “do not allow for adequate cleaning and sanitation.” It also noted paint flecks on the floor of corridors and damaged walls.
  • The factory used equipment too small for its intended purpose, describing labs overcrowded with samples.

Some of these problems, such as inadequate training of employees, may take considerable time to fix.

Emergent said in a statement on Wednesday that it is “committed to working with the FDA and Johnson & Johnson to quickly resolve the issues identified. … While we are never satisfied to see shortcomings in our manufacturing facilities or process, they are correctable and we will take swift action to remedy them.”

In an earlier statement on Monday, as it filed a notice with the U.S. Securities and Exchange Commission that it was pausing production at the Baltimore facility, Emergent said that it recognizes “the confusion these recent events may have caused our customers, our employees, and the public. We are steadfastly committed to full compliance with the FDA’s strict requirements. We acknowledge that there are improvements we must make to meet the high standards we have set for ourselves and to restore confidence in our quality systems and manufacturing processes.”

The administration of Johnson & Johnson COVID-19 vaccine in the U.S. was already put on hold last week due to concerns about a very rare blood clotting disorder that was found in a small number of people who had received the vaccine. Six cases were identified out of nearly 7 million administered doses.

The FDA said Wednesday that “it is often in the public’s best interest that the FDA work with firms to quickly resolve compliance matters to ensure that the public has access to medical products that meet the agency’s high standards for quality, safety and effectiveness.”

“We are doing everything we can to ensure that the COVID-19 vaccines that are given to the people of this nation have met the agency’s high standards for quality, safety and effectiveness. We know that every time an American, including members of our own families, receives a COVID-19 vaccine dose, they are putting their trust in us. We are working hard to maintain that trust,” the agency said.

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Source: https://www.npr.org/sections/coronavirus-live-updates/2021/04/21/989549809/fda-inspection-finds-numerous-problems-at-facility-intended-to-make-j-j-vaccine

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Masks Remain Extremely Effective Indoors, But Are They Necessary Outside?

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Most evidence points to the risks of coronavirus transmission outdoors as very low, according to Dr. Ashish Jha of Brown University’s School of Public Health. Karen Ducey/Getty Images hide caption

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Karen Ducey/Getty Images

Scientists and public health experts agree that masks are effective at lowering the spread of the coronavirus indoors, where the vast majority of transmission is likely to occur.

But what about outside?

About two dozen states have statewide mask mandates that generally require people to wear masks outside when they’re not able to stay at least 6 feet apart. Many cities have their own rules.

But with vaccinations accumulating, some health experts and journalists are arguing that now is a good time for authorities to ease up on outdoor mask requirements. Studies have linked transmission to indoor settings far more than outdoor ones, though data is limited and there are plenty of caveats.

Dr. Ashish Jha, dean of Brown University’s School of Public Health, notes that case numbers aren’t going down and they’ve been largely stagnant for the past month or two. But he says the situations driving it are groups of people gathering indoors without masks.

“Once you get outside, it starts becoming really, really uncommon for the virus to spread,” he tells NPR’s All Things Considered.

Some exceptions could involve people at packed rallies, standing or sitting close together for long periods of time. But beyond those scenarios, “there really just is not much spread happening outdoors.”

This interview has been edited for length and clarity.


Interview Highlights

Is there a number we can put on this? How uncommon it would be to pick up a case of COVID-19 if you were outside?

There are estimates that suggest maybe 1 in 1,000 infections happen outside. There are reasons to believe that if you just think about your risk, if you’re just out and about walking around, it’s probably even much less than that. So those rare instances occur in those contexts of sort of the large, packed rallies. I don’t know that we’ve seen really any cases of somebody who was just, let’s say, out for a walk or out for a run and picked up the infection that way. I think you really have to have a lot more exposure than that.

I am a jogger. … Do we know how much the risk increases when you’re breathing really hard, when you’re huffing and puffing, trying to get up that hill?

I think if somebody were right next to you and spending, let’s say, 10, 15 minutes running in that little stream of breath that you’re exhaling, there might be a risk. But somebody you’re running by who is there for just a second, the risk is — it’s extremely rare.

There will be people listening to us who are screaming at their radios right now saying it’s still spreading and the variants are out there and so far, most people aren’t fully vaccinated. You shouldn’t be having this conversation yet. What do you say to them?

I understand that first of all. But it’s really important to be able to have a nuanced discussion of what is safe and what is not. Because one of the problems is if we can’t have that discussion, then some people will adhere to all the rules, even ones that are not necessarily very useful, and other people will just ignore all of them.

And right now, while cases are spreading, while the variants are out there and very contagious ones like B.1.1.7 [are] really dominant, I do want people to do things that are safe. And part of that is telling people, you know, what restrictions they can let go of. And so I think it’s critically important that we keep indoor mask mandates in for a while. We can’t give up on those, not while infection numbers are high. But it also means telling people what they can relax on. And wearing masks outside, again, unless you’re in a very, very crowded space for extended periods of time, probably doesn’t do much to protect you or protect others.

Ayen Bior, Courtney Dorning and Elena Burnett produced and edited the audio interview.

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Source: https://www.npr.org/sections/coronavirus-live-updates/2021/04/21/989104800/masks-remain-extremely-effective-indoors-but-are-they-necessary-outside

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Supply vs Demand: When Will the Scales Tip on COVID-19 Vaccination in the U.S?

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For months, the main challenge with COVID-19 vaccine roll-out in the U.S. was that demand greatly outstripped supply. Indeed, limited supply, coupled with restricted eligibility in many parts of the country, meant that most people couldn’t get vaccinated if they wanted to. Now, with supply having increased significantly and eligibility fully open to adults in all states as of April 19, the main question has become, when will supply outstrip demand? While timing may differ by state, we estimate that across the U.S. as a whole we will likely reach a tipping point on vaccine enthusiasm in the next 2 to 4 weeks. Once this happens, efforts to encourage vaccination will become much harder, presenting a challenge to reaching the levels of herd immunity that are expected to be needed.

Our polls, and others, have shown that the share of adults who have either received one vaccine dose or want to get vaccinated as soon as they can has continually increased. As of March 21, it was 61% (up from 55% the month before). This increase reflects a shift from those saying they want to “wait and see” into the vaccine enthusiasm group. In fact, the share saying they want to “wait and see” has consistently fallen, as more people become enthusiastic about getting vaccinated.

If we use 61% as a current “outer edge” of vaccine enthusiasm, it translates into about 157 million adults. The latest data from the CDC indicate that almost 131 million adults (or 50.7% of all adults), had received at least one vaccine dose as of April 19. That leaves an additional 27 million adults to go before we hit up against the “enthusiasm limit”. At the current rate of first doses administered per day (using a 7-day rolling average, as of April 13) – or approximately, 1.7 million per day – we would reach the tipping point in about 15 days.  Of course if the pace of vaccination picks up, it could be sooner.  However, if those who say they want to get vaccinated right away face challenges in accessing vaccination, it could take longer.

Estimated Number of Days It Will Take to Reach All Adults in the U.S. Who Want a Vaccine With at Least One Dose (as of April 19, 2021)​

We also know that, over time, people have moved from the “wait and see” group to the vaccine enthusiasm group, suggesting that the 61% may be a floor, not a ceiling.  If about a third of the “wait and see” group moves into the enthusiasm group (comparable to what happened last month), the “outer edge” of vaccine enthusiasm would increase to 170 million people (or 66% of all adults); at the current rate of vaccine doses administered per day, it would take 22 days to reach the point at which supply outstrips demand.  If half of the “wait and see” group move, it would take about 28 days to reach the tipping point.

Thus, on average across the country, it appears we are quite close to the tipping point where demand for rather than supply of vaccines is our primary challenge. Federal, state, and local officials, and the private sector, will face the challenge of having to figure out how to increase willingness to get vaccinated among those still on the fence, and ideally among the one-fifth of adults who have consistently said they would not get vaccinated or would do so only if required. Now that supply has increased and eligibility has expanded, it will take a concerted effort to reach a sufficient level of vaccination for herd immunity, and to do so in a way that achieves equity goals as well.

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Source: https://www.kff.org/policy-watch/supply-vs-demand-when-will-the-scales-tip-on-covid-19-vaccination-in-the-u-s/

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