Top 10 Stories from 2020: COVID, COVID and More COVID
Without a doubt, the top topic of 2020, pretty much for any news outlet, was the COVID-19 pandemic. BioSpace ran its first story about the virus on January 22, titled, “China Coronavirus Update: What it is, How Dangerous it is, What is Being Done.” At that time, it had infected more than 440 people and killed nine in China and the first reported case in the U.S. had been the day before.
By March, the pandemic had begun to dominate our coverage and we designated a space for general COVID-19 coverage every day. That eventually dropped to three times a week and then just once a week, although almost every day since then has included multiple stories about the pandemic and biopharma’s efforts to test and/or develop therapies or vaccines for the disease. Keeping in mind that this has dominated the news cycle, here are the top 10 stories of 2020 in no particular order.
- Gilead Sciences’ Veklury (Remdesivir)
At the beginning of 2020, nobody knew how bad COVID-19 would be or that Gilead Sciences’ remdesivir, which had failed to work in Ebola, would turn out to be the first drug granted Emergency Use Authorization (EUA) for COVID-19 in Spring 2020 and then full approval on October 22, 2020. At the time of the EUA, it was really the only available treatment, but few physicians or analysts were particularly impressed with the drug’s effectiveness.
Back in April 2020, when the world was desperate for any drug that might help, Gilead reported encouraging results from its clinical trial of Veklury in COVID-19, with topline results from the Phase III SIMPLE trial evaluating 5-day and 10-day dosing in hospitalized patients with severe disease. It also reported positive data from the National Institute of Allergy and Infectious Diseases’ (NIAID) trial.
The results were promising, but not dazzling. One of the bigger takeaways was that the 5-day regimen appeared to have similar results to the 10-day regimen, which was good news because supply of the drug was limited. In terms of clinical improvement, the trial showed the time to clinical improvement for 50% of patients was 10 days in the 5-day cohort and 11 days in the 10-day cohort.
But a clinical trial by the World Health Organization (WHO) reported that the drug does not have any particular effect on a patient’s survival. The WHO has since taken remdesivir off their list of recommended treatments for COVID-19. Despite that, Veklury, which is far better known by its scientific name, remdesivir, is still a go-to drug to treat COVID-19.
- Pfizer and BioNTech’s COVID-19 Vaccine
On December 10, 2020, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) to the first vaccine against COVID-19. It was an mRNA vaccine created by Germany’s BioNTech and co-developed and manufactured with Pfizer. Within days the vaccine was distributed around the U.S., the U.K. and shortly after, in Europe. It was authorized for individuals ages 16 and above. On December 23, the U.S. government reached a deal with Pfizer for an additional 100 million doses by July 31, 2021.
- Moderna’s COVID-19 Vaccine
A week after Pfizer-BioNTech received EUA, Moderna received authorization for its own very similar mRNA COVID-19 vaccine and began distributing it in the U.S. on December 21. Unlike Pfizer-BioNTech, Moderna’s vaccine was developed in partnership with the U.S. National Institute of Allergy and Infectious Diseases (NIAID) and with funding from the U.S. government’s Operation Warp Speed, a program that threw money at the problem of COVID-19 vaccinations, and is overseeing distribution around the U.S. with the U.S. Centers for Disease Control and Prevention (CDC), McKesson, and partnerships with Walgreens and CVS.
- Eli Lilly’s Bamlanivimab for COVID-19
On November 9, 2020, the FDA granted Eli Lilly’s neutralizing antibody bamlanivimab EUA for mild to moderate COVID-19 in adults and pediatric patients 12 years and older who are at high risk for progressing to severe COVID-19 and/or hospitalization. The EUA was based on data from BLAZE-1, a Phase II trial in patients with recently diagnosed mild to moderate COVID-19 in the outpatient setting.
- Regeneron Pharmaceutical’s REGN-COV2 for COVID-19
On November 22, the FDA granted Regeneron Pharmaceuticals’ antibody cocktail casirivimab and imdevimab, together REGN-COV2, EUA for mild to moderate COVID-19 in adults and pediatric patients at least 12 years of age and weighing at least 40 kg.
- Operation Warp Speed
Operation Warp Speed (OWS) is a public-private partnership launched by the U.S. government to help and accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics and diagnostics. It was first announced on April 29, 2020, then officially launched on May 15. It was initially funded with approximately $10 billion from the CARES Act passed by the U.S. Congress on March 27. The primary focus, at least publicly, has been on vaccine development. In May, it had reduced a possible 93 vaccine programs to 14 top candidates, and then weeded them out to about six: Johnson & Johnson; AstraZeneca-University of Oxford and Vaccitech; Moderna; Novavax; Merck and IAVI; Sanofi and GlaxoSmithKline. Operation Warp Speed invested billions of dollars in each program to assist in development, and also oversaw acquisition of doses of the vaccines for U.S. use and is also overseeing distribution of the vaccines.
The year has been marked by a historic amount of scientific work on understanding COVID-19 and developing therapies for it, including the development of vaccines using a mix of new, untried technology such as mRNA, and more traditional vaccine technology. Despite controversies (See #8), never before has the U.S. public and people around the world paid so much attention to science, vaccine technology, clinical trials, immunology and convalescent and therapeutic antibodies, just to name a few. Much of this was possible by open communication between researchers worldwide, the publication of the SARS-CoV-2 genome in late December 2019, and the work of hundreds of thousands of researchers working for biopharma, governments, academia and research organizations worldwide.
As an article in Nature noted, “The speed of the coronavirus’s spread has been matched only by the pace of scientific insights. Almost as soon as SARS-CoV-2 was discovered, research groups worldwide started probing its biology, while others developed diagnostic tests or investigated public-health measures to control it.”
And multiple vaccines were developed in less than a year, broadly tested, authorized and began distribution. In the past, the fastest that had ever happened was four years.
President Trump and Controversy
It’s difficult to sum up in a paragraph or two how complicated President Trump and his handling of the pandemic has been. Here are just a few examples:
• Early in the pandemic, in February and March, Trump touted an older malaria drug, hydroxychloroquine, as a “game changer,” despite very little scientific data to back it up. This became a major political and cultural spark as Trump followers said anyone doubting the drug were lying and attacking Trump politically. On March 30, the FDA granted an EUA for the drug, then after more studies came out, the FDA withdrew the EUA on June 15. Trump continued to argue that the drug was effective for months afterwards, even when he eventually caught COVID-19.
• Trump played a cat-and-mouse game with Anthony Fauci, the world’s leading expert on infectious diseases and pandemic, the director of NIAID. He often talked publicly about how Fauci was wrong and hinted during campaign rallies that he might fire Fauci, while simultaneously saying what a nice guy Fauci was.
• On September 24, Trump signaled the White House may attempt to override the more stringent EUA guidance for a vaccine.
• On December 11, Trump demanded the resignation of FDA Commissioner Stephen Hahn if the Pfizer-BioNTech vaccine wasn’t granted EUA by the end of the day.
• Donald Trump and his son, Donald Trump Jr., accused Pfizer of deliberately waiting until after the U.S. presidential election to release the vaccine trial results in order to make him look bad.
- Venture Capital Funds
Although not directly related to COVID-19, a number of firms launched new and large venture capital funds for life sciences. Several indicated it was partly in response to the growing attention to biotech and life sciences during the pandemic. For example, On April 2, Cambridge, Massachusetts-based venture capital firm Flagship Pioneering announced it had closed on a $1.1 billion for its seventh “origination fund” to support biotech startups. Flagship began raising the funds in January. On the same day, ARCH Venture Partners announced two new venture capital funds to invest in early-stage biotech companies with a combined total of $1.46 billion. They are ARCH Venture Fund X and ARCH Venture Fund X Overage.
On April 6, Deerfield Management announced the closing of the Deerfield Healthcare Innovations Fund II with $840 million. The fund will focus on investing in science startups related to new therapies and technology related to “improve the way healthcare is delivered to patients.”
On December 8, Forbion, a European life science venture capital firm, announced its fifth fund, Forbion V. It has €460 million, or $545 million (U.S.), to invest in life science companies. Investors in the fund include a variety of existing and new limited partners, both groups made up of specialized institutional and corporate investors. They include Pantheon, Wilshire Associates, the Ewing Marion Kauffman Foundation and Argentum.
Forbion’s offices are in The Netherlands, Germany, and Singapore. It is focused on the life sciences, particularly in the biopharma space. It currently manages more than €1.7 billion.
- CRISPR Pioneers Doudna and Charpentier Win Nobel Prize in Chemistry
There is little doubt that CRISPR gene editing is and will continue to revolutionize biology and medicine. The Nobel Committee confirmed their belief in that by awarding the Nobel Prize in Chemistry to Emmanuelle Charpentier and Jennifer A. Doudna for their discovery and development of CRISPR.
Of it, Göran K. Hansson, secretary-general of the Royal Swedish Academy of Sciences, said the award was about “rewriting the code of life.”
The winners were announced at the Royal Swedish Academy of Sciences in Stockholm. The prize comes with a cash award of 10 million Swedish krona, which comes to $1.12 million (U.S.), shared by the laureates, and a gold medal for each winner. The formal ceremonies will be held online in December because of the pandemic.
Charpentier, who is French, is based at the Max Planck Unit for the Science of Pathogens in Berlin, and Doudna is at the University of California, Berkeley.
CRISPR stands for Clustered Regularly Interspaced Short Palindromic Repeats. With that and the Cas9 enzyme, the system allows researchers to specifically cut the genome at a desired location, which allows existing genes to be removed or new genes to be inserted.
Broadly, CRISPR-Cas9 as a technology was discovered by Doudna and Charpentier, who was then at the University of Vienna, then the Umea Centre for Microbial Research in Sweden, then the Helmoltz Centre for Infection Research in Braunschweig, Germany. The two began a collaboration in 2011 and published their landmark paper in Science in 2012.