Frequently Asked Questions

Genentech currently does not make vaccines, however, we are contributing in the fight against COVID-19 in other ways: our scientific knowledge and research expertise in infectious diseases and in antibody-based therapeutics as well as our skilled workforce and specialized manufacturing capabilities.

As the global COVID-19 situation continues to evolve, we remain focused on ensuring patient safety and data integrity across all of our clinical trials.

The pandemic is now impacting our studies in nearly all regions of the world and we’re working closely with trial sites to find new and flexible ways to adapt to the challenges they are facing and safely enable continued study participation wherever possible.

Each country is in a different phase of COVID-19 outbreak and response, and we support our clinical trial sites in making decisions that are in the best interests of their patients, their institutions, and their communities.

We will continue to assess the situation on an ongoing basis at the study, site and country level.

Genentech has initiated several studies to evaluate the safety and efficacy of Actemra^® (tocilizumab) in adult patients with severe COVID-19 pneumonia. Actemra is not currently FDA-approved for this use.

COVACTA and EMPACTA are the first global Phase III, multi-center, randomized, placebo-controlled studies of Actemra in patients hospitalized with COVID-19 associated pneumonia. Both studies were published in the New England Journal of Medicine. Genentech continues to evaluate data from both studies.

Genentech also has partnered with Gilead Sciences on REMDACTA, a Phase III, randomized, double-blind, multicenter study to evaluate the safety and efficacy of Actemra in combination with remdesivir, versus placebo plus remdesivir, in hospitalized patients with severe COVID-19 associated pneumonia. The initial results of the trial were announced on March 10, 2021.

Please visit Actemra.com for the full Prescribing Information, including Boxed Warning and Medication Guide, for additional Important Safety Information.

In August 2020, Roche and Genentech announced a collaboration with Regeneron in the fight against COVID-19 to develop, manufacture and distribute Regeneron investigational COVID-19 antibody cocktail of casirivimab and imdevimab, known as REGN-COV2, to people around the globe. In November 2020, Regeneron announced the casirivimab and imdevimab antibody cocktail was granted Emergency Use Authorization in the United States by Food and Drug Administration for the treatment of mild-to-moderate COVID-19 in adults, as well as in paediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization. Additionally, Roche is collaborating with Regeneron to increase global supply of casirivimab and imdevimab, with the aim of having more than 2 million treatment doses available annually.  Learn more here

In October 2020, Roche announced a collaboration with Atea Pharmaceuticals on the development, manufacturing, and distribution of AT-527, an orally administered direct-acting antiviral (DAA) currently in Phase II clinical trials for hospitalized patients with moderate COVID-19. A Phase III clinical trial, expected to start this year, will explore the potential use in patients outside of the hospital setting.

If you are a healthcare provider and have questions about this clinical trial, please contact our clinical trial number at 888-662-6728.

The COVID-19 pandemic continues to evolve, Roche is working closely with governments and health authorities around the world to help ensure that reliable, high-quality diagnostic solutions are available globally. Since March of 2020, Roche has been granted Emergency Use Authorization in the United States by the Food and Drug Administration for a portfolio of lab and point-of-care tests to detect the virus' genetic signature or antibodies to identify an immune response, including: 

• March 2020 - the cobas® SARS-CoV-2 high-volume molecular test designed to detect the novel virus that causes COVID-19 disease. Hospitals and reference laboratories can run the test on Roche’s fully automated cobas® 6800 and cobas® 8800 Systems, which are widely available in the U.S. and around the world. Learn more here.
• May 2020 - the Elecsys® Anti-SARS-CoV-2 serology (blood) test designed to help determine if an individual has been exposed to the SARS-CoV-2 virus and if they have developed antibodies against SARS-CoV-2. Learn more here.
• June 2020 - the Elecsys® IL-6 test which measures levels of the biomarker interleukin 6 (IL-6) and can be used to help identify patients with confirmed COVID-19 disease who could be at high risk of intubation with mechanical ventilation. Learn more here.
• September 2020 - the cobas® SARS-CoV-2 & Influenza A/B test, for use on the cobas® 6800/8800 Systems, designed to detect and differentiate SARS-CoV-2, influenza A and/or influenza B in individuals suspected of respiratory infection. Learn more here.
• September 2020 - the cobas® SARS-CoV-2 & Influenza A/B multiplex test, for use on the cobas® Liat® system, designed to detect and differentiate SARS-CoV-2, influenza A and/or influenza B in individuals suspected of respiratory infection. Learn more here.
• December 2020 - the Elecsys® Anti-SARS-CoV-2 S serology (blood) antibody test designed to measure the level of antibodies in people who have been exposed to the SARS-CoV-2 virus. Learn more here.
  • Additionally, Roche has entered into a collaboration with Moderna to utilise the Elecsys® Anti-SARS-CoV-2 S antibody test in Moderna’s mRNA-1273 vaccine research trials. Learn more here.

Please note that these tests must be ordered by a medical professional and people should speak with their healthcare provider about diagnostic testing. For questions, please contact the Roche Diagnostics COVID-19 hotline at 866-987-6243 or visit this page.

We have not experienced supply issues for our portfolio of medicines related to the global COVID-19 pandemic. We are closely monitoring and responding to the evolving situation and have robust business continuity and mitigation strategies in place. We're working closely with health authorities; federal, state and local governments; and distribution partners to manage inventory levels equitably and best meet the needs of patients.

For customers with further questions, please contact Genentech Customer Service at 1-800-551-2231 or your Account Manager.

All of our manufacturing facilities comply with current Good Manufacturing Practice regulations, which include hygiene standards to safeguard against potential contamination or cross-contamination and mandatory requirements to report any issues.

In addition, we have robust pandemic protocols in place, we are monitoring the situation closely in real-time across our global manufacturing network, and we are confident that we are taking all appropriate steps to minimize infection risks.

Genentech takes the health and safety of our employees, their families and our local communities very seriously, and we are actively responding to the COVID-19 public health issue.

We have a COVID-19 Task Force dedicated to preparing for and protecting against the transmission of COVID-19 on our campuses and in the local community, while ensuring the critical work required to bring our medicines to those who need them continues. The measures we have in place include:

• Requiring those who are able to work from home to do so and restricting access to our campuses only to personnel needed to carry out essential biotech business continuity activities on site.
• Adhering to facial coverings, social distancing and additional cleanings throughout our campuses to help protect those who continue to work on site in service of our patients.
• Requiring Business Continuity Onsite Staff who regularly work on campus to complete a COVID-19 PCR virus test once per week.
• Utilizing our robust contact tracing process if a COVID-19 related exposure is reported.
• Offering limited onsite vaccine administration for a small cohort of eligible Business Continuity Onsite Staff in South San Francisco and select U.S. sites.
• Encouraging virtual rather than in-person interactions across the country to continue to meet the needs of our customers and their patients.
• Restricting all global and domestic company air travel only to trips that support business continuity.
• Cancelling/postponing all in-person Genentech meetings and events.
• Suspending visitor access to our campuses and conducting virtual meetings.
• Engaging our on-site medical teams, who are trained and ready to respond 24/7. 
• Working closely with appropriate health authorities and fully complying with all Centers for Disease Control and Prevention (CDC) and applicable local government regulations and protocols.

We are aware of individuals who have been on our campuses and subsequently tested positive for COVID-19. Per our protocol, anyone identified to have had close contact with diagnosed individuals has been notified and advised to self-isolate for a 14-day period.

We are confident that appropriate measures have and are being taken to support the persons affected and to minimize the risk to others.

In 2020, Genentech and the Genentech Foundation committed $42 million to help address the devastating impact of the COVID-19 pandemic. This support included emergency response grants as well as funds for longer-term recovery efforts, with an emphasis on low-income households and communities of color. Learn more about our approach to giving to help address critical health needs, strengthen schools and provide community grassroots support.

As part of this $42 million commitment, the Genentech Foundation awarded more than $4.3 million to community colleges and universities to address the needs of low-income and BIPOC students, and help prevent deeper learning gaps for this already vulnerable student population.

In addition, Genentech and The Genentech Foundation funded a $3.2 million initiative with the Hasso Plattner Institute of Design (the d. School) at Stanford University to encourage and support bold thinking and new solutions for K-12 learning challenges. The Reach for the Upside initiative invites public school districts and their community partners to workshop and implement tangible solutions to address challenges exacerbated by the COVID-19 pandemic.

Our employees also gave generously through a number of enhanced matching initiatives, including campaigns focused on racial justice and health equity. Over the course of 2020, Genentech employees donated more than $4.8 million to more than 1,500 nonprofit organizations nationwide, much of which was focused on COVID-19 needs.

We recognize that the pandemic is ongoing, and even as we hope for recovery amidst vaccine availability in 2021, the impacts will be long lasting for communities, students and health systems. This is not a one-and-done challenge, and we have embedded awareness of COVID-related challenges and needs into all of our grantmaking. We will continue to learn from our conversations with grantees and stakeholders and seek new ways of driving both immediate relief and longer term transformational change with all of our funding choices.

Please visit funding.gene.com for questions about new or existing grants.