iBIO launched the COVID Response Fund in March of 2020 to support the healthcare ecosystem and communities most impacted by the COVID pandemic. Since it was launched the iBIO response fund has provided over 1 million donated masks, medial supplies and has helped support vaccine education and vaccine clinics in Illinois.

Phase 1B will begin when Phase 1A is substantially complete. It will include all Illinois residents aged 65 and older and “frontline essential workers,” as outlined by ACIP:

• first responders (e.g., firefighters and police officers)
• corrections officers
• food and agricultural workers
• U.S. Postal Service workers
• manufacturing workers
• grocery store workers
• public transit workers
• and those who work in the education sector (teachers and support staff members) as well as child care workers

All in all, Phase 1B totals approximately 1.3 million people who qualify as “frontline essential workers” and 1.9 million adults age 65 and over, totaling 3.2 million eligible Illinoisans.

As the state enters Phase 1B, the government will be utilizing every available resource at the state’s disposal to ensure that as many Illinoisans as possible can receive the vaccine as quickly as possible.

Large manufacturers interested in self-administring the vaccine to their 1B eligible employees should register with the Illinois Comprehensive Automated Immunization Registry Exchange. More information can be found on the IDPH website: https://www.dph.illinois.gov/topics-services/prevention-wellness/immunization/icare

Read the FDA’s announcement

FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine

Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts

Today, the U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S.

“The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling this devastating pandemic that has affected so many families in the United States and around the world,” said FDA Commissioner Stephen M. Hahn, M.D. “Today’s action follows an open and transparent review process that included input from independent scientific and public health experts and a thorough evaluation by the agency’s career scientists to ensure this vaccine met FDA’s rigorous, scientific standards for safety, effectiveness, and manufacturing quality needed to support emergency use authorization. The tireless work to develop a new vaccine to prevent this novel, serious, and life-threatening disease in an expedited timeframe after its emergence is a true testament to scientific innovation and public-private collaboration worldwide.” 

The FDA has determined that Pfizer-BioNTech COVID-19 Vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that Pfizer-BioNTech COVID-19 Vaccine may be effective in preventing COVID-19. The data also support that the known and potential benefits outweigh the known and potential risks, supporting the vaccine’s use in millions of people 16 years of age and older, including healthy individuals. In making this determination, the FDA can assure the public and medical community that it has conducted a thorough evaluation of the available safety, effectiveness and manufacturing quality information.

The Pfizer-BioNTech COVID-19 Vaccine contains messenger RNA (mRNA), which is genetic material. The vaccine contains a small piece of the SARS-CoV-2 virus’s mRNA that instructs cells in the body to make the virus’s distinctive “spike” protein. When a person receives this vaccine, their body produces copies of the spike protein, which does not cause disease, but triggers the immune system to learn to react defensively, producing an immune response against SARS-CoV-2.

“While not an FDA approval, today’s emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine holds the promise to alter the course of this pandemic in the United States,” said Peter Marks, M.D., Ph.D., Director of the FDA’s Center for Biologics Evaluation and Research. “With science guiding our decision-making, the available safety and effectiveness data support the authorization of the Pfizer-BioNTech COVID-19 Vaccine because the vaccine’s known and potential benefits clearly outweigh its known and potential risks. The data provided by the sponsor have met the FDA’s expectations as conveyed in our June and October guidance documents. Efforts to speed vaccine development have not sacrificed scientific standards or the integrity of our vaccine evaluation process. The FDA’s review process also included public and independent review from members of the agency’s Vaccines and Related Biological Products Advisory Committee. Today’s achievement is ultimately a testament to the commitment of our career scientists and physicians, who worked tirelessly to thoroughly evaluate the data and information for this vaccine.”

FDA Evaluation of Available Safety Data

Pfizer BioNTech COVID-19 Vaccine is administered as a series of two doses, three weeks apart. The available safety data to support the EUA include 37,586 of the participants enrolled in an ongoing randomized, placebo-controlled international study, the majority of whom are U.S. participants. These participants, 18,801 of whom received the vaccine and 18,785 of whom received saline placebo, were followed for a median of two months after receiving the second dose. The most commonly reported side effects, which typically lasted several days, were pain at the injection site, tiredness, headache, muscle pain, chills, joint pain, and fever. Of note, more people experienced these side effects after the second dose than after the first dose, so it is important for vaccination providers and recipients to expect that there may be some side effects after either dose, but even more so after the second dose.

It is mandatory for Pfizer Inc. and vaccination providers to report the following to the Vaccine Adverse Event Reporting System (VAERS) for Pfizer-BioNTech COVID-19 Vaccine: all vaccine administration errors, serious adverse events, cases of Multisystem Inflammatory Syndrome (MIS), and cases of COVID-19 that result in hospitalization or death.

FDA Evaluation of Available Effectiveness Data 

The effectiveness data to support the EUA include an analysis of 36,523 participants in the ongoing randomized, placebo-controlled international study, the majority of whom are U.S. participants, who did not have evidence of SARS-CoV-2 infection through seven days after the second dose. Among these participants, 18,198 received the vaccine and 18,325 received placebo. The vaccine was 95% effective in preventing COVID-19 disease among these clinical trial participants with eight COVID-19 cases in the vaccine group and 162 in the placebo group. Of these 170 COVID-19 cases, one in the vaccine group and three in the placebo group were classified as severe. At this time, data are not available to make a determination about how long the vaccine will provide protection, nor is there evidence that the vaccine prevents transmission of SARS-CoV-2 from person to person.

The EUA Process

On the basis of the determination by the Secretary of the Department of Health and Human Services on February 4, 2020, that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and then issued declarations that  circumstances exist justifying the authorization of emergency use of unapproved products, the FDA may issue an EUA to allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent COVID-19 when there are no adequate, approved, and available alternatives.

The issuance of an EUA is different than an FDA approval (licensure) of a vaccine. In determining whether to issue an EUA for a product, the FDA evaluates the available evidence and assesses any known or potential risks and any known or potential benefits, and if the benefit-risk assessment is favorable, the product is made available during the emergency. Once a manufacturer submits an EUA request for a COVID-19 vaccine to the FDA, the agency then evaluates the request and determines whether the relevant statutory criteria are met, taking into account the totality of the scientific evidence about the vaccine that is available to the FDA.

The EUA also requires that fact sheets that provide important information, including dosing instructions, and information about the benefits and risks of the Pfizer-BioNTech COVID-19 Vaccine, be made available to vaccination providers and vaccine recipients.

The company has submitted a pharmacovigilance plan to FDA to monitor the safety of Pfizer-BioNTech COVID-19 Vaccine. The pharmacovigilance plan includes a plan to complete longer-term safety follow-up for participants enrolled in ongoing clinical trials. The pharmacovigilance plan also includes other activities aimed at monitoring the safety profile of the Pfizer-BioNTech COVID-19 vaccine and ensuring that any safety concerns are identified and evaluated in a timely manner.

The FDA also expects manufacturers whose COVID-19 vaccines are authorized under an EUA to continue their clinical trials to obtain additional safety and effectiveness information and pursue approval (licensure).

The EUA for the Pfizer-BioNTech COVID-19 Vaccine was issued to Pfizer Inc. The EUA will be effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated, and may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance.

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 nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Related Information

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To date we have sourced and donated over 130,000 pieces of protective equipment and more than 200,000 supplies needed for COVID-19 diagnostic and testing.

iBIO COVID-19 PPE Response Fund
Donations and Purchases
Last Updated: May 4, 2020

Monetary donations: $1,069,877
Items purchased to date with monetary donations:

• Goggles: 3,080
• Protective Clothing: 13,740
• Gloves: 93,100
• Surgical Masks: 14,930
• Testing Swabs: 41,200
• IR Thermometers: 550

Product donations

• N95 Masks: 3,620
• Surgical Masks: 2,430
• Sanitizer: 2,430
• Testing Viral Transport Medium: 125,000

To learn more and to make a monetary or unused-medical-product donation, please visit the
iBIO COVD-19 PPE Response Fund.

The short survey below will help iBIO identify best practices in the community. We will share the results of this survey with the community. Click here if the survey does not load below.

Click here for the RFI

General Information

This Request for Information (RFI) invites Respondentsto submit non-price information about the availability of the specified types of supplies and services herein. The RFI is not a procurement method and will not result in a Respondentsreceiving a contract (44 Ill. Adm. Code 1.15). Responding to the RFI is not a prerequisite to participate in a future procurement(s) and does not obligate the State to conduct a future procurement. Further, a response to this RFI does not provide any advantages to the Respondent in future contractsthat may result from the collection of this information. All information received in a Respondent’s response will be available for public review (44 Ill. Adm. Code 1.2050[j]).

Respondents are invited to provide non-proprietary, non-price information within the RFI’s Statement of Work. Respondents are prohibited from providing pricing, the details of customized solutions, sample procurement specifications, or any other information outside the scope of the RFI because it could disqualify Respondent from participating in future related procurements (30 ILCS 500/50-10.5[e]).

However, Respondent’s may provide general information about industry trends and innovations, products, services or industry best practices that are not specifically tailored to meet the State’s needs.

To date we have sourced and donated over 130,000 pieces of protective equipment and more than 160,000 supplies needed for COVID-19 diagnostic and testing.

iBIO COVID-19 PPE Response Fund
Donations and Purchases
Last Updated: April 27, 2020

Monetary donations: $1,069,877
Items purchased to date with monetary donations:

• Goggles: 3,080
• Protective Clothing: 13,740
• Gloves: 93,100
• Surgical Masks: 14,930
• Testing Swabs: 41,200
• IR Thermometers: 550

Product donations

• N95 Masks: 3,620
• Surgical Masks: 2,430
• Sanitizer: 2,430
• Testing Viral Transport Medium: 125,000

To learn more and to make a monetary or unused-medical-product donation, please visit the
iBIO COVD-19 PPE Response Fund.

iBIO, the Illinois Biotechnology Innovation Organization, today announced a summary of the iBIO COVID-19 PPE Response Fund’s impact since its March 23 launch. The most noteworthy development in the last week is a $200,000 charitable contribution from the Lundbeck US Charitable Fund. 

The Lundbeck US Charitable Fund is a charitable organization established by Lundbeck LLC, one of several Illinois-based life sciences organizations that responded to the call to support the iBIO COVID-19 PPE Response Fund. Horizon Therapeutics, Astellas Pharma US and Baxter International Inc., also contributed to the iBIO Institute’s program to support nurses, doctors and first responders throughout Illinois.

Majority-owned by a non-profit research foundation, Lundbeck occupies a unique position in Illinois’ life science community. “At Lundbeck, we are dedicated to giving back to the communities where we work and live. Here in Illinois, we are inspired by the frontline healthcare professionals and first responders who are working tirelessly to care for those affected by the coronavirus,” said Peter Anastasiou, executive vice president and head of Lundbeck North America. “We are proud to support the iBIO COVID-19 PPE Response Fund, and we applaud iBIO’s efforts to harness the collective commitment and resources of Illinois’ life sciences community in the face of this crisis.”

In addition to bolstering the healthcare system’s ability to respond to the pandemic, the Lundbeck US Charitable Fund has made significant contributions to response funds in communities where the company has a meaningful presence, including Illinois, Seattle and San Diego. These contributions will enable local nonprofit organizations to provide interim housing and shelter, direct financial assistance, and primary healthcare and mental healthcare services to vulnerable community members.

“Lundbeck has been a strong supporter of iBIO, the iBIO Institute and our state-wide life sciences community. This charitable contribution is the latest example of Lundbeck’s leadership, and it will enable us to significantly expand the amount of PPE we can provide to Illinois’ heroes on the front line in the battle against the coronavirus,” said iBIO President and CEO John Conrad.

iBIO directs monetary donations from corporations, foundations and individuals to its BIO Business Solutions lab supply partner, which places ongoing orders for PPE equipment to meet the urgent needs of first responders, nurses and doctors throughout Illinois. The purchased items are then sent to the Illinois Emergency Management Agency (IEMA), which distributes products to healthcare and emergency response systems statewide to ensure that the supply is equitable.

The iBIO COVID-19 PPE Response Fund’s impact during its first four weeks in operation:

Monetary donations: $1,069,877
Items purchased to date with monetary donations:

• Goggles: 3,080
• Protective Clothing: 13,740
• Gloves: 93,100
• Surgical Masks: 14,930
• Testing Swabs: 21,200
• IR Thermometers: 550

Product donations

• N95 Masks: 3,620
• Surgical Masks: 2,430
• Sanitizer: 2,430
• Testing Viral Transport Medium: 85,000

To learn more and to make a monetary or unused-medical-product donation, please visit the
iBIO COVD-19 PPE Response Fund.

“Throughout this pandemic we have been facilitating test development to ensure patients access to accurate diagnostics, which includes supporting the development of reliable and accurate at-home sample collection options,” said FDA Commissioner Stephen M. Hahn, M.D. “The FDA’s around-the-clock work since this outbreak began has resulted in the authorization of more than 50 diagnostic tests and engagement with over 350 test developers. Specifically, for tests that include home sample collection, we worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, hospital or other testing site. With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home.”

This reissued EUA for LabCorp’s molecular test permits testing of a sample collected from the patient’s nose using a designated self-collection kit that contains nasal swabs and saline. Once patients self-swab to collect their nasal sample, they mail their sample, in an insulated package, to a LabCorp lab for testing.  LabCorp intends to make the Pixel by LabCorp COVID-19 Test home collection kits available to consumers in most states, with a doctor’s order, in the coming weeks.

The LabCorp home self-collection kit includes a specific Q-tip-style cotton swab for patients to use to collect their sample. Due to concerns with sterility and cross-reactivity due to inherent genetic material in cotton swabs, other cotton swabs should not be used with this test at the present time. The FDA continues to work with test developers to determine whether or not Q-tip-style cotton swab can be used safely and effectively with other tests.

This authorization only applies to the LabCorp COVID-19 RT-PCR Test for at-home collection of nasal swab specimens using the Pixel by LabCorp COVID-19 home collection kit. It is important to note that this is not a general authorization for at-home collection of patient samples using other collection swabs, media, or tests, or for tests fully conducted at home.

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 nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.