WASHINGTON – The Partnership for America’s Health Care Future believes that every American should have access to affordable, high-quality health care. To that end, our members are working hand in hand to expand access to the world’s best doctors, nurses, specialists, treatments and technology.

The Federal Government And Leading Pharmaceutical Companies Are Working Together To Combat COVID-19 With Innovative Vaccines And Treatments

Moderna Vaccine Is Highly Protective And Prevents Severe Covid-19, Data Show. “Newly released data confirmed on Tuesday that Moderna’s coronavirus vaccine is highly protective, setting the stage for its emergency authorization this week by federal regulators and the start of its distribution across the country. The Food and Drug Administration intends to authorize use of the vaccine on Friday, people familiar with the agency’s plans said. The decision would give millions of Americans access to a second coronavirus vaccine beginning as early as Monday.” (Noah Weiland, Denise Grady & Carl Zimmer, “Moderna Vaccine Is Highly Protective and Prevents Severe Covid-19, Data Show,” The New York Times, 12/15/20)

Pfizer’s Covid-19 Vaccine Receives Key FDA Panel Recommendation. “An independent panel of experts has overwhelmingly voted to recommend that the Food and Drug Administration authorize Pfizer’s Covid-19 vaccine for emergency use in people ages 16 and older. The vote Thursday afternoon was 17 in favor of the authorization and four against, with one person abstaining.” (Erika Edwards, “Pfizer’s Covid-19 Vaccine Receives Key FDA Panel Recommendation,” NBC News, 12/10/20)

Moderna Becomes Second Company To Request Emergency FDA Authorization For COVID-19 Vaccine Candidate. “Biotech company Moderna applied Monday for an emergency use authorization from the U.S. Food and Drug Administration after receiving more good news about the safety and effectiveness of its candidate COVID-19 vaccine. Moderna will be the second vaccine maker to request authorization from the federal government after similarly positive results for Pfizer and its German collaborator BioNTech’s candidate vaccine. (Karen Weintraub, “Moderna Becomes Second Company To Request Emergency FDA Authorization For COVID-19 Vaccine Candidate,” USA Today, 11/30/20)

Pfizer And Moderna: How 2 Very Different Companies Developed A COVID-19 Vaccine. “Pfizer and Moderna are likely to be the first companies to see their respective vaccines authorized in the United States, possibly before the end of the year. Through their journeys to a COVID-19 vaccine have been eerily similar, the companies themselves could not be more different. Pfizer is a multinational pharmaceutical giant, while Moderna is a small biotechnology company that has never brought a drug to the market.” (Sony Salzman, “Pfizer And Moderna: How 2 Very Different Companies Developed A COVID Vaccine,” ABC News, 11/19/20)

Pfizer, Biontech To Submit Emergency Authorization Request To FDA Friday For COVID-19 Vaccine.” “Pfizer and partner BioNTech announced they will submit a request on Friday to the U.S. Food and Drug Administration for emergency use authorization of their COVID-19 vaccine candidate. The submission, which is based on a vaccine efficacy rate of 95% demonstrated in the Phase 3 clinical study with no serious safety concerns to date, will potentially enable the use of the drug in high-risk populations in the United States by the middle to end of December, according to a joint press release.” (Morgan Winsor, “Pfizer, Biontech To Submit Emergency Authorization Request To FDA Friday For COVID-19 Vaccine,” ABC News, 11/20/20)

• New Pfizer Results: COVID-19 Vaccine Is Safe And 95% Effective. “The drug maker Pfizer said on Wednesday that its coronavirus vaccine was 95 percent effective and had no serious side effects – the first set of complete results from a late-stage vaccine trial as Covid-19 cases skyrocket around the globe. The data showed that the vaccine prevented mild and severe forms of Covid-19, the company said. And it was 94 percent effective in older adults, who are more vulnerable to developing severe Covid-19 and who do not respond strongly to some types of vaccines.” (Katie Thomas, “New Pfizer Results: Coronavirus Vaccine Is Safe and 95% Effective,” The New York Times, 11/18/20)

• Pfizer Says COVID-19 Vaccine Is Looking 90% Effective. “Pfizer said Monday that an early peek at the data on its coronavirus vaccine suggests the shots may be a surprisingly robust 90% effective at preventing COVID-19, putting the company on track to apply later this month for emergency-use approval from the Food and Drug Administration.” (Linda A. Johnson & Lauran Neergaard, “Pfizer Says COVID-19 Vaccine Is Looking 90% Effective,” Associated Press, 11/9/20)

Moderna’s COVID-19 Vaccine Is 94.5% Effective, According To Company Data. “The Moderna vaccine is 94.5% effective against coronavirus, according to early data released Monday by the company, making it the second vaccine in the United States to have a stunningly high success rate. ‘These are obviously very exciting results,’ said Dr. Anthony Fauci, the nation’s top infectious disease doctor. ‘It’s just as good as it gets – 94.5% is truly outstanding.’ Moderna heard its results on a call Sunday afternoon with members of the Data Safety and Monitoring Board, an independent panel analyzing Moderna’s clinical trial data.” (Elizabeth Cohen, “Moderna’s Coronavirus Vaccine Is 94.5% Effective, According To Company Data”, CNN, 11/16/20)

Biopharmaceutical Leaders And Research Partners Have Added New Drug Development Programs In A Matter Of Weeks To Help Fast-Track COVID-19 Treatments. “The biopharma industry and its research partners have added new drug development programs in a matter of weeks.  For instance, under Operation Warp Speed, a public-private partnership aimed at fast-tracking COVID-19 treatments, the government is supporting five companies with the goal of having 100 million vaccine doses available by November – a project of scale and speed never seen in the life sciences industry.” (Giovanni Caforio, “Bristol Myers Squibb CEO: Why The COVID-19 Pandemic Has Me Optimistic About The Future Of Medical Research,” Fortune, 6/9/20)

The National Institutes of Health (NIH) Started A Public-Private Group To Speed Up Virus Vaccine Work. “The National Institutes of Health, CDC, FDA and other federal health agencies are partnering with pharmaceutical cos. to quicken coronavirus vaccine research and development.  The Accelerating Covid-19 Therapeutic Interventions and Vaccines partnership will develop a framework for prioritizing vaccine and drug candidates, NIH says in a statement.  Drug cos. include AbbVie, AstraZeneca, Evotec, GlaxoSmithKline, Johnson & Johnson, Pfizer and Sanofi.  NOTE: HHS, CDC, FDA, and European Medicine Agency are part of coordinated research.” (Teaganne Finn, “NIH Starts Public-Private Group To Speed Up Virus Vaccine Work,” Bloomberg, 4/17/20)  

Consensus Seems To Be Building Globally Around The Idea That Bluetooth-Based Contact Tracing Could Be A Practical Use Of Technology To Contain The Spread Of The Coronavirus. “Both governments and advocacy groups are agreeing that using Bluetooth to sense the proximity of users’ phones could be more effective and less of a civil rights problem than tapping location-based data that apps and service providers often collect.” (Caitlin Owens, “Outlines For How Contact Tracing Should Work,” Axios, 4/17/20)

In A March Meeting, The Trump Administration Announced That It Would Work With Top Pharmaceutical Executives To Collaborate And Build Vaccines And Treatments To Combat The Coronavirus. (Jeff Mason, “Trump Administration Says Drug Makers Will Work Together To Combat Coronavirus,” Reuters, 3/2/20)

• Attendees, All Of Whom Are Working On Vaccines Or Treatments For The Virus, Included: Gilead Sciences, Regeneron Pharmaceuticals, Moderna, GlaxoSmithKline, Pfizer, Johnson & Johnson And Sanofi. (Jeff Mason, “Trump Administration Says Drug Makers Will Work Together To Combat Coronavirus,” Reuters, 3/2/20)

Vice President Mike Pence: “Our Pharmaceutical Companies, Which Are Recognized As The Greatest In The World, Have Already Formed A Consortium To Work Together, To Share Information In The Development Of Therapeutics And Vaccines.” (Lev Facher, “Trump’s Tone Toward Pharma Shifts, As He Looks To Drug Makers To Help With Coronavirus Response,” STAT, 3/2/20)

PhRMA Executive Vice President Of Public Affairs Robert Zirkelbach: “[Pharmaceutical Companies] Are Putting At Risk Significant Resources To Develop, Test And Manufacture New Treatments And Vaccines Without Knowing Whether They Will Actually Work For Patients.” (Nicholas Florko, “The Coronavirus Could Help Pharma Reset Its Reputation In Washington,” STAT, 3/3/20)

The Biopharmaceutical Industry Is Collaborating With U.S. And Global Health Authorities To Combat The Coronavirus. “In these unprecedented times, we are coming together to achieve one shared goal: the eradication of COVID-19.  The decades-long investments we have made in new technology, research and treatments have prepared us to act swiftly:

• We are rapidly screening our vast global libraries of medicines to identify potential treatments and have numerous clinical trials underway to test new and existing therapies;
• We are dedicating our top scientists and using our investments in new technologies to speed the development of safe and effective vaccines;
• We are sharing the learnings from clinical trials in real time with governments and other companies to advance the development of additional therapies;
• We are expanding our unique manufacturing capabilities and sharing available capacity to ramp up production once a successful medicine or vaccine is developed;
• We are collaborating with government agencies, hospitals, doctors and others to donate supplies and medicines to help those affected around the world;
• We are working with governments and insurers to ensure that when new treatments and vaccines are approved they will be available and affordable for patients.”

(The Latest On The Biopharmaceutical Industry’s Efforts To Beat Coronavirus, PhRMA, Accessed 3/27/20)

America’s Vast Life-Science Industry Is Helping Combat The Coronavirus. “Most important is developing a therapy to treat Covid-19 or perhaps prevent people from contracting it.  America is home to a vast, dynamic life-science industry.  This is its moment.  This is why decades of drug investment and development matter so much.” (Scott Gottlieb, “How Long Will The Coronavirus Lockdowns Go On?” The Wall Street Journal, 3/22/20)

Rapid Point-Of-Care Coronavirus Tests Will Be Used To Support Areas Of The Country With The Least Access To Testing. “Rapid point-of-care coronavirus tests will be used to support areas of the country with the least access to testing, as well as nursing homes, White House coronavirus coordinator Deborah Birx told reporters today.  ‘These are new tests, and we have prioritized the groups that we think have the least access to testing now,’ Birx said.  Priority will be given to the Indian Health Service and rural areas that do not have access to labs that perform high-volume coronavirus tests, she said.” (David Lim, “Indian Health Service, Rural Areas To Have Priority Access To Rapid Coronavirus Tests,” POLITICO, 4/2/20)

Pharmaceutical Companies Are Investing In Research And Development And Donating Supplies As Part Of Push To Combat COVID-19:

Treatment and Cures Innovation By The Free Market Is The Best Hope We Have For Defeating COVID-19. “Developed by Gilead Sciences, the biotech firm, remdesivir helped to reduce the length of hospital stays in some Covid-19 patients.  While those results are preliminary, and a much larger trial is underway, the FDA was right to allow the drug’s use for patients who have little recourse.  Until a vaccine is discovered, better treatments will be our main medical defense against the disease.” (Editorial, “Drug Innovation To The Rescue,” The Wall Street Journal, 5/1/20)

“Drugmakers Are Reconfiguring Manufacturing Plants And Hiring Hundreds Of New Workers To Be Ready To Make Coronavirus Drugs And Vaccines Should They Prove In Testing To Be Effective In Fighting Off The Virus.” “Johnson & Johnson, Pfizer Inc. and other companies are gearing up so they can make hundreds of millions of doses of coronavirus pills and shots as quickly as possible if studies support their worth.  For some companies, the efforts involve shifting production of existing drugs to other factories, rejiggering supply chains and even partnering with rivals.” (Peter Loftus & Joseph Walker, “Drugmakers Prepare To Make Coronavirus Treatments,” The Wall Street Journal, 4/23/20)

The FDA Has Authorized The First At-Home COVID-19 Sample Collection Kit. “The FDA has given emergency authorization to the first coronavirus test that allows people to collect their own samples at home, using a nasal swab, before mailing them off to a lab for analysis.  The test, made by LabCorp, could help cut down on the amount of personal protective equipment health providers are using while collecting patient samples for testing.” (David Lim, “FDA Authorizes First At-Home Coronavirus Sample Collection Kit,” POLITICO, 4/21/20)

Three Potential Coronavirus Vaccines Are Moving Ahead In Tests. “In the U.S., a shot made by the National Institutes of Health and Moderna Inc. isn’t far behind.  The first person to receive that experimental vaccine last month returned to a Seattle clinic Tuesday for a second dose.  NIH infectious disease chief Dr. Anthony Fauci said there are ‘no red flags’ so far and he hoped the next, larger phase of testing could begin around June.” (Associated Press, “Three Potential Coronavirus Vaccines Moving Ahead In Tests,” Los Angeles Times, 4/15/20)

FDA Authorizes COVID-19 Saliva Test For Emergency Use. “The US Food and Drug Administration has authorized a saliva test for ‘emergency use’ for diagnosing Covid-19.  Rutgers University, where the test was developed in collaboration with other groups, announced the FDA authorization on Tuesday after formally receiving it over the weekend.” (Jacqueline Howard, “FDA Authorizes Covid-19 Saliva Test For Emergency Use,” CNN, 4/14/20)

Just Three Months After The Start Of The Coronavirus Pandemic, Several Biotech Companies Are Beginning Trials Of Promising Vaccines And Treatments. “As the coronavirus pandemic spreads at unprecedented rates, invading the lungs of people of all ages, ethnicities and medical histories, companies are ratcheting up their efforts to fight the disease with accelerated schedules for creating new vaccines, and beginning clinical trials for potential treatments.” (Knvul Sheikh & Katie Thomas, “More Coronavirus Vaccines And Treatments Move Toward Human Trials,” The New York Times, 4/8/20)

A Coalition Of Health Systems, Tech Giants And Healthcare Vendors Are Collaborating To Increase COVID-19 Testing And Coordinate Early Therapies. “The private industry effort, spearhead by Mayo Clinic’s John Halamka, M.D. and other industry leaders, plans to leverage the strengths of healthcare organizations, technology companies, non-profits, academia, and startups to provide a focused response to the coronavirus outbreak.  ‘Each coalition member is bringing its unique assets, sharing resources and plans, and working together to support those on the front lines in responding to COVID-19,’ the COVID-19 Healthcare Coalition said in a press release.” (Heather Landi, “Mayo Clinic, Amazon, Others Launch Collaboration To Increase COVID-19 Testing, Vaccine Development,” Fierce Healthcare, 3/25/20)

Abbott Labs Has Shipped More Than 1.4 Million Rapid COVID-19 Tests Across The U.S. “Abbott Laboratories has shipped 1.4 million of its highly touted ‘rapid’ molecular tests for the Coronavirus strain COVID-19 in the last month across the U.S., keeping ahead of its commitments to ramp up production.” (Bruce Japsen, “Abbott Labs Eclipses 1.4 Million Rapid Coronavirus Tests Shipped Across U.S.,” Forbes, 5/5/20)

• Abbott Labs Rolling Out Coronavirus Antibody Tests. “Abbott Laboratories is launching a laboratory-based blood test designed to detect antibodies to identify whether someone has had the Coronavirus strain COVID-19.  The antibody test, which will run on Abbott’s Architect i1000SR and i2000SR laboratory instruments found in hospitals and big reference labs, is different than diagnostic tests Abbott and other companies have launched that test whether a person has the Coronavirus strain COVID-19.” (Bruce Japsen, “Abbott Labs Rolling Out Coronavirus Antibody Tests,” Forbes, 4/15/20)

AbbVie Has Donated Supplies Of Kaletra/Aluvia, An Experimental Treatment For COVID-19, Has Collaborated With National And International Health Organizations, And Is Donating $35 Million To Help Support Underserved Communities And Health Care Systems Working To Address The Impact Of The COVID-19 Global Pandemic.  (AbbVie, “AbbVie Statement On Coronavirus And Lopinavir/Ritonavir,” Press Release, 2/27/20; “Member Company Efforts To Combat Coronavirus Outbreak,” PhRMA, 4/1/20)

Alkermes “Has Made Donations To Five Organizations In The Local Communities Where It Operates. These Organizations Focus On Delivering Food And Support For Low-Income Families And Children, As Well As Seniors.” (“Member Company Efforts To Combat Coronavirus Outbreak,” PhRMA, 4/1/20)

Amgen Is Joining The Race To Discover New Drugs That Can Treat The Novel Coronavirus. “Amgen, which is partnering with Adaptive Biotechnologies Corp.  in the effort, is an unlikely hunter of antiviral treatments.  The company, a pioneer of biotechnology, is best known for its drugs for cancer, with other products targeting high cholesterol, kidney disease and migraines.  Although it lacks infectious-disease expertise, Amgen, of Thousand Oaks, Calif., believes it might have something to contribute to fighting the pandemic because of its expertise in antibody drugs.  In the treatment of viruses, the drugs aim to hunt down the pathogens, attach to them and then stop them from wreaking havoc.” (Joseph Walker, “Biotech Pioneer Amgen Joins Hunt For Coronavirus Drug,” The Wall Street Journal, 4/2/20)

Amgen “Announced An Initial Commitment Of Up To $12.5 Million To Support U.S. And Global Relief Efforts To Address Critical Needs In Communities Impacted By The COVID-19 Pandemic.” (“Member Company Efforts To Combat Coronavirus Outbreak,” PhRMA, 4/1/20)

AstraZeneca Is “Donating Nine Million Face Masks ‘To Support Health Care Workers Around The World As They Respond To The COVID-19 Global Pandemic” And “Is Accelerating The Development Of Its Diagnostic Testing Capabilities To Scale-Up Screening And Is Also Working In Partnership With Governments On Existing Screening Programs To Supplement Testing.” (“Member Company Efforts To Combat Coronavirus Outbreak,” PhRMA, 4/1/20)

Biogen “Has Committed $10 Million To Support Global Response Efforts And Communities Around The World Impacted By The COVID-19 Pandemic.” (“Member Company Efforts To Combat Coronavirus Outbreak,” PhRMA, 4/1/20)

Boehringer Ingelheim “Has Made A Number Of Financial Contributions Totaling Over $1 Million To Protect Health Care Professionals In The Critical Services They Are Providing To Patients,” And Has Donated Medicines And Medical Supplies.” (“Member Company Efforts To Combat Coronavirus Outbreak,” PhRMA, 4/1/20)

Eli Lilly To Start Testing Experimental Drug In COVID-19 Patients Soon. “Drugmaker Eli Lilly & Co. said it expects to begin human testing as soon as next month for an experimental Covid-19 treatment that uses antibodies derived from the blood of people who have recovered from the viral disease.  The testing could yield results by late summer and, if successful, potential emergency authorization by the U.S. Food and Drug Administration by early fall, Lilly Chief Executive David Ricks said in an interview Thursday.” (Peter Loftus, “Lilly To Start Testing Experimental Drug In Coronavirus Patients Soon,” The Wall Street Journal, 4/23/20)

Genentech Is “Donating $7 Million To Organizations Dedicated To Providing Emergency Public Health Response, Food Assistance, Housing And Care For The Most Vulnerable In Our Communities.” (“Member Company Efforts To Combat Coronavirus Outbreak,” PhRMA, 4/1/20)

Gilead Has Received Emergency FDA Authorization For Remdesivir To Treat COVID-19. “The Food and Drug Administration has granted emergency use authorization for Gilead’s remdesivir drug to treat the coronavirus, President Donald Trump announced Friday.  Earlier in the week, White House health advisor Dr. Anthony Fauci said data from a coronavirus drug trial testing Gilead’s drug showed ‘quite good news’ and sets a new standard of care for Covid-19 patients.” (William Feuer, “Gilead Gets Emergency FDA Authorization For Remdesivir To Treat Coronavirus, Trump Says,” CNBC, 5/1/20)

• Gilead Is Donating 1.5 Million Doses Of Experimental Coronavirus Treatment. “Gilead Sciences, Inc. is donating 1.5 million doses of remdesivir, its investigational drug for COVID-19, for compassionate use, expanded access and clinical trials, Chairman and CEO Daniel O’Day said Saturday.  The doses are intended for patients with severe symptoms who will receive them intravenously on a daily basis in a hospital setting, the CEO said in a letter posted on Gilead’s website.  The 1.5 million doses could amount to more than 140,000 treatment courses in COVID-19 patients, depending on the duration of treatment, he said.” (Dustin Blitchok, “Gilead To Donate 1.5M Doses Of Experimental Coronavirus Treatment: ‘The Right Thing To Do,’” Benzinga, 4/5/20)
• Gilead Has Been Working In Consultation With Regulatory Authorities To Establish Additional Expanded Access Programs For Remdesivir, Our Investigational Medicine For COVID-19. “The programs enable hospitals or physicians to apply for emergency use of remdesivir for multiple severely ill patients at a time.  These are patients who cannot take part in clinical trials and where the word ‘emergency’ is all too real for them, their families and the healthcare providers advocating on their behalf.” (Daniel O’Day, “An Update On COVID-19 From Our Chairman & CEO,” Gilead, 4/4/20)
• Gilead Sciences Has Provided The Drug Remdesivir And “Scientific Input” To Multiple Clinical Studies Evaluating The Efficacy Of Remdesivir In Adults Diagnosed With COVID-19. (Gilead, “Gilead Sciences Initiates Two Phase 3 Studies Of Investigational Antiviral Remdesivir For The Treatment Of COVID-19,” Press Release, 2/26/20)

GlaxoSmithKline CEO Calls Coronavirus Vaccine Partnership With Sanofi An ‘Unprecedented Collaboration.’” GlaxoSmithKline CEO Emma Walmsley on Tuesday told CNBC’s Jim Cramer that her company’s newly announced partnership with industry peer Sanofi is an ‘unprecedented collaboration’ between competitors.  The European pharmaceutical giants are combining their resources to develop a Covid-19 vaccine and aim to produce a batch within the next 20 months.” (Tyler Clifford, “GlaxoSmithKline CEO Calls Coronavirus Vaccine Partnership With Sanofi An ‘Unprecedented Collaboration,’” CNBC, 4/14/20)

• GlaxoSmithKline Is “Donating $10 Million To WHO And The UN Foundation’s COVID-19 Solidarity Response Fund To Support WHO And Partners Prevent, Detect And Manage The Pandemic, Particularly Where The Needs Are The Greatest.” (“Member Company Efforts To Combat Coronavirus Outbreak,” PhRMA, 4/1/20)

Harvard-Affiliated Hospitals Have Launched A New Effort To Make A COVID-19 Vaccine, With Help From Celtics Co-Owner. “Since 2017, drug companies have used the so-called adeno-associated virus, or AAV, as a way to deliver DNA in two gene therapies approved to treat two rare inherited diseases.  But it has never been used successfully to make a vaccine.” (Jonathan Saltzman, “Harvard-Affiliated Hospitals Launch New Effort To Make Coronavirus Vaccine, With Help From Celtics Co-Owner,” Boston Globe, 5/4/20)

• Working With The U.S. Department Of Health & Human Services’ (HHS) Biomedical Advanced Research and Development Authority (BARDA), Janssen Pharmaceuticals, A Johnson & Johnson Subsidiary, Is Contributing To The Accelerated Development Of A COVID-19 Vaccine For Clinical Studies. (Johnson & Johnson, “Johnson & Johnson Announces Collaboration With U.S. Department Of Health & Human Services To Accelerate Development Of A Potential Novel Coronavirus Vaccine,” Press Release, 2/11/20)
• Johnson & Johnson To Begin Human Trials On A COVID-19 Vaccine In July. “Johnson & Johnson moved up the start of human clinical trials for its experimental vaccine against the highly contagious coronavirus by two months to the second half of July, as the drugmaker rushes to develop a prevention for COVID-19, the company said on Wednesday.” (Julie Steenhuysen & Saumya Joseph, “J&J Moves Up Start Of Coronavirus Vaccine Human Trials To July,” Reuters, 6/10/20)

• Johnson & Johnson Said That It Had Made Progress On A Vaccine To Prevent Covid-19 And That The Product Could Be Ready In Early 2021. “J&J said it could get approval under an emergency-use authorization to make the vaccine widely available early next year.  The company said it has also chosen two back-up constructs in case the lead candidate falters.” (Matt Grossman, Johnson & Johnson To Begin Human Trials Of Covid-19 Vaccine By September, Wall Street Journal, 3/30/20)
• Johnson & Johnson Plans To Have 100 Million Vaccines For Americans By Spring. “Johnson & Johnson board member Dr. Mark McClellan told CNBC that “if the clinical trial works out,” the company could significantly increase the nation’s Covid vaccine supply availability within the coming weeks.” (Emily DeCiccio, “Johnson & Johnson Plans To Have 100 Million Vaccines For Americans By Spring, Board Member Says,” CNBC, 1/21/21)

Merck “Has Provided A Half A Million (500,000) Personal Protective Masks To New York City For Use As Part Of Urgent Efforts To Address The Outbreak In New York. The Company Has Also Donated 300,000 Masks For New Jersey.”(“Member Company Efforts To Combat Coronavirus Outbreak,” PhRMA, 4/1/20)

Moderna, Pfizer And Inovio Have Started Clinical Trials On A COVID-19 Vaccine. “Scientists are scrambling to develop a vaccine for Covid-19, which has already claimed the lives of 259,796 people from around the world.  More than ever before, pharma, biotechs, start-ups, research institutes and universities are working together to develop a vaccine and identify new therapies to treat the symptoms of this disease.  Moderna, Pfizer and Inovio have already started clinical trials.” (Dennis O’Brien, “The Timeline On Some Of The Most Promising Covid-19 Vaccine And Treatments Under Development Right Now,” CNBC, 5/7/20)

• Moderna Inc. Entered A Pact With Lonza Group AG Aimed At Manufacturing 1 Billion Doses A Year Of A Potential COVID-19 Vaccine. “Moderna Inc., one of the leaders among U.S. companies developing experimental vaccines against the coronavirus, entered a pact with Lonza Group AG aimed at manufacturing 1 billion doses a year.  The companies announced a global agreement under which the Swiss chemical and pharmaceutical company will ramp up output of the proposed vaccine, which is based on a novel technology that relies on genetic material called mRNA.  They expect the first batches to be produced in the U.S. in July.” (Eric Pfanner & James Paton, “Vaccine Leader Signs Deal For 1 Billion Covid-19 Doses A Year,” Bloomberg, 5/1/20)

• Moderna’s COVID-19 Vaccine Candidate Advances To Next Stage Of Testing. “Moderna Inc. said late Monday its candidate for a coronavirus vaccine will get to be evaluated further.  The biotech company said it has submitted a new-drug application with the U.S. Food and Drug Administration to evaluate the vaccine candidate, mRNA-1273, in a more extensive study if supported by safety data from an initial study.” (Claudia Assis, “Moderna’s Coronavirus Vaccine Candidate Advances To Next Stage Of Testing,” MarketWatch, 4/27/20)

• Doctors Start Giving Second Round Of Shots Developed By Moderna To Volunteers In Seattle COVID-19 Vaccine Trial. “The vaccine, called mRNA-1273, was developed by scientists at the National Institute of Allergy and Infectious Diseases and at the Cambridge, Mass.-based biotechnology company Moderna, Inc.” (Elizabeth Weise, “Doctors Start Giving Second Round Of Shots To Volunteers In Seattle COVID-19 Vaccine Trial,” USA Today, 4/22/20)

• Moderna Has Agreed To A Deal With The U.S. Government On Scaling Up Testing For A Vaccine. “The US government will fund the development and manufacture of a potential vaccine for the Sars-CoV-2 coronavirus by the Boston-based biotech Moderna, in a deal worth up $483m.  The Biomedical Advanced Research and Development Agency, known as Barda, will help Moderna scale up manufacturing of the vaccine candidate for the testing stage to millions of doses a month in 2020, and tens of millions a month next year.  Moderna developed the potential vaccine – from the genetic sequence of the virus to delivery of a vial that could be tested – In a record-breaking 42 days.” (Hannah Kuchler, “Moderna Agrees Deal With US Government On Scaling Up Testing For Vaccine,” Financial Times, 4/16/20)

• Moderna Shipped A Supply Of Novel Coronavirus Vaccines To The National Institutes Of Health To Be Used In Phase I Studies. (Moderna, “Moderna Ships mRNA Vaccine Against Novel Coronavirus (mRNA-1273) For Phase 1 Study,” Press Release, 2/24/20)
• Moderna On Track to Make 100 Million Vaccine Doses By End Of March. “Moderna Inc.’s MRNA -0.02% leader said the drugmaker is on track to produce enough doses of its new Covid-19 vaccine to help meet President-elect Joe Biden’s goal to administer 100 million vaccine doses in the first 100 days after he takes office on Wednesday.” (Peter Loftus, “Moderna on Track to Make 100 Million Vaccine Doses by End Of March, CEO Says,” The Wall Street Journal, 1/19/21)

Novartis Has Created A $20 Million Global Fund To Support Impacted Communities,” And Entered “Into New Collaborative Research Efforts Such As The COVID-19 Therapeutics Accelerator.” (“Member Company Efforts To Combat Coronavirus Outbreak,” PhRMA, 4/1/20)

Pfizer To Manufacture Gilead’s Antiviral Drug Remdesivir. “Pharmaceutical giant Pfizer announced Friday that it will manufacture and supply Gilead Sciences’ antiviral drug remdesivir, a possible treatment against the coronavirus.  The multi-year agreement marks one of many external manufacturing efforts to ‘scale up supply of the investigational treatment for COVID-19,’ said Pfizer, which will produce the drug at its McPherson, Kansas, facility.” (Daniella Genovese, “Pfizer To Manufacture Gilead’s Antiviral Drug Remdesivir,” FOX Business, 8/7/20)

Roche Received Emergency Approval Of COVID-19 Antibody Test And Aims To Boost Output. “Roche has won emergency approval from the U.S. Food and Drug Administration (FDA) for an antibody test to determine whether people have ever been infected with the coronavirus, the Swiss drugmaker said on Sunday.  Thomas Schinecker, Roche’s head of diagnostics, said the company aims to more than double production of tests from about 50 million a month to significantly more than 100 million a month by the end of the year.” (Aakriti Bhalla & John Miller, “Roche Wins U.S. Nod For COVID-19 Antibody Test, Aims To Boost Output,” Reuters, 5/3/20)

Sanofi Is Building On Previous Work To Develop A Coronavirus Vaccine In Collaboration With HHS’s BARDA. (Sanofi, “Sanofi Joins Forces With U.S. Department Of Health And Human Services To Advance A Novel Coronavirus Vaccine,” Press Release, 2/18/20)

Sorrento Therapeutics And Mount Sinai Are Joining Forces To Develop A COVID-19 Antibody Shield. “Sorrento Therapeutics and Mount Sinai Health System in New York City have joined forces to develop an antibody cocktail they hope will shield against Covid-19 infection for up to two months.  The treatment, called COVI-SHIELD, is designed to be administered as often as necessary, with each dose expected to provide antiviral protection for health care and other essential workers.” (Lori Ioannou, “Sorrento Therapeutics And Mount Sinai Join Forces To Develop Covid-19 Antibody Shield,” CNBC, 5/8/20)

In Addition To Developing A Treatment For COVID-19, Takeda Is Exploring Treatments Options Within Its Existing Pipeline And Partnering With The Innovative Medicines Initiative In Europe. (Rajeev Venkayya, “Rajeev Venkayya, President, Global Vaccine Business Unit On The Latest On The Coronavirus And Takeda,” Takeda, Accessed 3/11/20)

Sandoz, A Major Manufacturer Of Generic Prescriptions, Publicly Committed “To Ensure Stable Pricing For A Basket Of Essential Medicines The Company Markets, Which May Help To Treat Coronavirus Patients.” (Sandoz, “Sandoz Commits To Keep Prices Stable For Basket Of Essential Medicines Amid Growing Concerns About Supply Impact Of Coronavirus,” Press Release, 2/26/20)

Researchers In The U.S. And China Have Developed An AI Tool That Can Predict ‘Wet Lung.’ “Once deployed, the algorithm could assist doctors in making choices about where to prioritize care in resource-stretched health care systems, said Megan Coffee, a physician and professor at New York University’s Grossman School of Medicine who co-authored a paper on the finding in the journal Computers, Materials & Continua.  The tool discovered several surprising indicators that were most strongly predictive of who went on to develop so-called acute respiratory disease syndrome (ARDS), a severe complication of the COVID-19 illness that fills the lungs with fluid and kills around 50 percent of coronavirus patients who get it.” (Staff, “AI Tool Predicts Which Coronavirus Patients Get Deadly ‘Wet Lung,’” Agence France-Presse, 3/30/20) 

Medtronic Is Sharing Its Portable Ventilator Design Specifications And Code For Free. “Healthcare and biomedical engineering company Medtronic  was in the news recently because Tesla CEO Elon Musk had discussions with the company about the automaker’s potential plans to build ventilator hardware in order to address the COVID-19 crisis.  Today it’s doing something potentially far more impactful.  Medtronic is making available to anyone the full design specifications, produce manuals, design documents and, in the future, software code for its Puritan Bennett (PB) 560 portable ventilator hardware.” (Darrell Etherington, “Medtronic Is Sharing Its Portable Ventilator Design Specifications And Code For Free To All,” Tech Crunch, 3/30/20)

Ochsner Health Secures 5-Minute Coronavirus Test That Could Go To ERs And Labor Units. “Ochsner Health System officials will soon begin using rapid COVID-19 tests in their emergency rooms and other areas to screen out patients who have the disease, they said Thursday.” (Jessica Williams, “Ochsner Health Secures 5-Minute Coronavirus Test That Could Go To ERs, Labor Units,” Nola.com, 4/2/20)

Long Island’s Henry Schein Rolls Out The Standard Q COVID-19 Rapid Test That Gives Results In 15 Minutes. “A Long Island-based medical supply giant is rolling out a new 15-minute coronavirus testing kit.  Henry Schein’s new test is called the Standard Q COVID-19 Rapid Test.  It’s an antibody rapid blood test that the company says can give results in minutes instead of hours or days.” (Staff, “Long Island’s Henry Schein Rolls Out 15-minute COVID-19 Test,” News 12 Long Island, 3/30/20)

Tulane Lab Offers New COVID-19 Test That Gives Results In Four Hours. “Tulane Medical Center’s laboratory is now offering a new COVID-19 test that can give patients their results within four hours.  Tulane University said in a statement this week that the test was created through a joint effort by the Tulane University School of Medicine, the Louisiana State University School of Medicine, Tulane Medical Center, LCMC Health and Roche Diagnostics.” (Staff, “Tulane Lab Offers New COVID-19 Test That Gives Results In Four Hours,” WDSU NBC, 4/1/20)

Virgin Orbit Partnered With Medical Researchers At The University Of California Irvine And The University Of Texas At Austin To Develop A Ventilator Device. “Richard Branson’s California-based rocket company Virgin Orbit partnered with medical researchers and developed a ventilator device that the company plans to mass produce and send to hospitals around the United States to fight the coronavirus.” (Michael Sheetz, “Richard Branson’s Rocket Company Virgin Orbit To Begin Mass Producing Ventilators,” CNBC, 3/30/20)

University Of Alabama At Huntsville And The World’s Fastest Supercomputer Join The Fight Against The Coronavirus. “Dr. Jerome Baudry is a professor in the Department of Biological Sciences at the University of Alabama at Huntsville.  Dr. Baudry and his lab are involved in a project that is using the Oak Ridge National Laboratory’s Summit supercomputer to examine compounds to fight the virus that has already killed 34,807 people as of early Monday morning.  The compounds under review include drugs already available with safe profiles, as well as natural products.  Compounds identified as possible future drugs will also be studied.” (Brandon Moseley, “UAH Researchers And The World’s Fastest Supercomputer Join The Fight Against The COVID-19 Virus,” Alabama Political Reporter, 3/30/20) 

The University Of Alabama At Birmingham Is Testing A COVID-19 Vaccine Made By Biopharmaceutical Company Altimmune. “The testing at UAB will investigate immune responses to the vaccine in mice – a key step before the Gaithersburg, Maryland-based Altimmune can launch a Phase 1 human safety and immunogenicity trial in patients in Q3 of this year.  The COVID-19 vaccine, called AdCOVID, is a single-dose vaccine candidate that is delivered by an intranasal spray.” (Jeff Hansen, “UAB Will Test A COVID-19 Vaccine Candidate Created By Altimmune Inc.,” Yellow Hammer, 3/30/20) 

• The University Of Alabama At Birmingham Is Taking Part In An NIH-Sponsored Global Clinical Trial To Test Novel Therapeutic Agents To Combat COVID-19. “UAB is one of several sites being activated for the trial.  The study will be conducted in up to 75 sites globally.  Dr. Paul Goepfert, professor of medicine in the UAB Division of Infectious Diseases, serves as the UAB principal investigator for this study.” (Jerry Underwood, “UAB To Participate In Global Clinical Trial For Coronavirus Treatment,” Made In Alabama, 3/26/20)

FDA Commissioner Approves Coronavirus Antibody Test Produced By Cellex Inc. “Food and Drug Administration Commissioner Stephen Hahn announced Thursday the approval of a coronavirus antibody testing system produced by Cellex Inc., the first of its kind approved for use by FDA.” (Christian Datoc, “FDA Commissioner Approves Coronavirus Antibody Test Produced By Cellex Inc., The First Of Its Kind,” Daily Caller, 4/2/20)

The FDA Granted “Emergency Use Authorization” To Cepheid, A California Company That Makes A Faster Molecular Test For Coronavirus. “The Food and Drug Administration late Friday approved the first coronavirus test that can be conducted entirely at the point of care for a patient – and deliver results in 45 minutes. The FDA granted ‘emergency use authorization’ to Cepheid, a California company that makes a rapid molecular test for the coronavirus. The turnaround time for Cepheid’s product is far shorter than for the tests being used, which are typically sent to centralized labs that may not return results for days. The FDA authorization is for use in ‘patient care settings,’ including doctors’ offices, but the test initially will be used primarily by hospitals and emergency departments, the company said.” (Laurie McGinley, “FDA Authorizes First Rapid ‘Point-Of-Care’ Test For Coronavirus,” The Washington Post, 3/21/20)