FDA Approves First COVID-19 Vaccine Which Can Be Distributed by Global WholeHealth Partners Corp (OTC: GWHP) as US Anticipates Considerable Uptick in Vaccination Rates, as Stated in 8K Filing 06/15/21
SAN CLEMENTE, CA, Aug. 24, 2021 (GLOBE NEWSWIRE) -- via NewMediaWire - Global WholeHealth Partners Corp. (OTC: GWHP) is readying for sales due to the transition from Emergency Use Status to Full FDA Approval of Vaccine developed by Pfizer-BioNTech, as stated in 8K filing 06/15/21.
The agreement between Global WholeHealth Partners Corp and Nunzia Pharmaceutical Inc. has been a great benefit to Global by Nunzia allowing Global to broker and sell through Nunzia's agreement the vaccines, as stated in 8K filings 03/08/21, 06/09/21, 06/15/21, and 06/24/21.
Global WholeHealth Partners Corp. (OTC: GWHP), a multinational supplier of over 70+ FDA Approved Diagnostic Tests announces full FDA Approval of the First COVID-19 Vaccine distributed by the company.
The U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine and will now be marketed as Comirnaty (koe-mir'-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older.
"This is tremendous news and couldn't have come at a better time as we've witnessed the vaccination rates start to decline recently," said Charles Strongo, CEO of Global WholeHealth Partners Corp. (OTC: GWHP).
"The FDA's approval of the Pfizer-BioNTech COVID-19 Vaccine should serve as the vote of confidence that many people needed to hear. Especially the folks who have been hesitant on getting vaccinated," Strongo continued.
"We (Global) were early supporters of the Pfizer-BioNTech COVID-19 Vaccine and obtained distribution rights to it back in June," Strongo added
Link to the Global WholeHealth Partners Corp.'s 8K for Pfizer-BioNTech COVID-19 Vaccine distribution rights can be found by clicking here.
To support the FDA's approval decision, the FDA reviewed updated data from the clinical trial which supported the Emergency Use Authorization and included a longer duration of follow-up in a larger clinical trial population.
In the FDA's review for approval, the agency analyzed effectiveness data from approximately 20,000 vaccine and 20,000 placebo recipients ages 16 and older who did not have evidence of the COVID-19 virus infection within a week of receiving the second dose. The safety of Comirnaty was evaluated in approximately 22,000 people who received the vaccine and 22,000 people who received a placebo 16 years of age and older.
Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.
More than half of the clinical trial participants were followed for safety outcomes for at least four months after the second dose. Overall, approximately 12,000 recipients have been followed for at least 6 months.
The most commonly reported side effects by those clinical trial participants who received Comirnaty were pain, redness and swelling at the injection site, fatigue, headache, muscle or joint pain, chills, and fever. The vaccine is effective in preventing COVID-19 and potentially serious outcomes including hospitalization and death.
"The FDA's approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. While this and other vaccines have met the FDA's rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product," said acting FDA Commissioner Janet Woodcock, M.D.
"While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated. Today's milestone puts us one step closer to altering the course of this pandemic in the U.S.," Woodcock added
"Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty's safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities," said Peter Marks, M.D., Ph.D., director of FDA's Center for Biologics Evaluation and Research.
"We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.," Marks added.
The FDA's announcement and press release regarding the approval of the Pfizer-BioNTech COVID-19 Vaccine can be viewed.
"Since the beginning of this Pandemic, our primary focus has been directed to stopping the spread of this terrible virus. We (Global) have been very active in the rollout of our COVID Test Kits, then the rollout of the Emergency Use Vaccines as soon as they were available, and now here we are with a fully approved and licensed COVID-19 Vaccine," said in closing by Charles Strongo, CEO of Global WholeHealth Partners Corp. (OTC: GWHP).
Global WholeHealth Partners Corp. (OTC: GWHP) provides cutting edge technology using In-vitro Diagnostic (IVD) Real-Time PCR Machines for detection of SARS-CoV-2 IgM/IgG antibodies in human serum, plasma, or whole blood. It has led the fight against vector borne terminal diseases such as Ebola, ZIKA, Dengue, Malaria, Influenza and Tuberculosis, Corona Viruses, and among other vector borne diseases with an FDA Certificate of Exportability (2260-11-2019). The company was founded on March 7, 2013, and is headquartered in San Clemente, CA.
GWHP develops, manufactures, and markets in vitro diagnostic (IVD) tests for OTC, or consumer-use as well as professional rapid diagnostic point-of-care (POC) test kits for hospitals, physicians' offices, and medical clinics in the US and abroad. Currently, the Company has 70 products FDA approved and many are approved for OTC use, and 29 POC products approved by the FDA CLIA WAIVED.
Call or email about special prices for this announcement on all the tests. EUA Antibody Tests for under $5.00 per test is one of many tests that are being offered at special prices.
The Company is not making any express or implied claims that its product has the ability to eliminate, cure or contain the Covid-19 (or SARS-2 Coronavirus) at this time.
This press release contains "forward-looking statements." Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure regulatory approvals for the sale of our products, (iv) intense competition in the medical device industry from much larger, multinational companies, (v) product liability claims, (vi) product malfunctions, (vii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiii) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC's website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
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