Overview of the pharmaceutical market before COVID – 19
Forecast of the market before COVID-19 appearance
This statistic displays the top 10 global pharmaceutical companies based on their anti-viral revenues worldwide in 2017, and a projection for 2024. AbbVie is expected to generate some 3.2 billion U.S. dollars in anti-viral revenues by 2024. An anti-viral drug is used to treat viral infections but usually only prevents the development of the pathogen. Projections before COVID – 19 pandemic appearance had predicted that Gilead Science was going to be the first company in the world in the pharma industry as per 2017 – 2024. However, it seems that a virus could change this ranking and much more than this on a global scale.
Back to the strong competition roots beginning – As of March 2020
Description of the Methodology
This section tries to give some bases of the coronavirus strong competition start in the spring of 2020. Below are listed the most recognized companies that have worked with coronavirus vaccine development and their details. For a better read of this section and for the matter of ease the long reading of it, the summary of the content is organized in a table accessible in this link.
The Excel file contains 3 sheets. In the first one there are listed the companies that are working on the coronavirus treatment and in the second one there are listed the most probable companies that could compete in the market by working on coronavirus vaccine development. In both of the tables it is shown information about the financial indicators in the stock market of these companies as per December 2nd 2020. The data is provided for the most competitive and well – performing companies in the stock market.
These indicators are:
- P/E Ratio
- Div Yield
- Market Cap
Apart from the financial indicators that shows a clear understanding of the stocks’ performance, the table is filled with other data that might be helpful, such as partners that the companies are collaborating, geographical location of the headquarters of the companies and the link to their website in case any new further detail might be needed in the future.
Furthermore, as part of that Excel sheet there is the third sheet named “Stock Performance”. In this section there is captured an image of the stock performance of the most competitive companies as per December 13th and 14th 2020. The line charts show the stock performance up to date of those companies and the most meaningful financial indicators appear there as well.
These elements are:
- Mkt Cap
- P/E Ratio
- Div Yield
- Prev Close
- 52-wk high
- 52-wk low
The overall reason for inserting these charts is to ease the visual comparison among the companies.
In the U.S., many of the publicly traded companies that are initiating development have received funding from two organizations: the Biomedical Advanced Research and Development Authority, or BARDA, which is a division of the Department of Health and Human Services, and the National Institute of Allergy and Infectious Diseases, or NIAID, a division of the National Institutes of Health. Some companies have also received funding from Coalition for Epidemic Preparedness Innovations, or CEPI, a global organization based in Oslo that has provided millions of dollars in funding to vaccine makers. Other companies are funding trials by themselves or through life-sciences-company partnerships.
These are some of the companies developing treatments or vaccines in the U.S. for COVID-19, as of early May. (An earlier version of the article included several adjuvant platform technologies that are used to aid the development process and a privately held company, but they have since been removed to focus on public companies.)
Amgen and Adaptive Biotechnologies
Type: Antibody treatment
Background: The very early-stage collaboration between Amgen Inc. AMGN, 0.77% and Adaptive Biotechnologies Corp. ADPT, -1.82% seeks to discover antibodies that can be used to prevent or treat COVID-19. Financial terms of the exclusive collaboration will be completed “in the coming weeks,” the companies said April 2. “There may well be more than one generation of antibody therapeutics entering the clinic,” Amgen R&D EVP David Reese told investors on an earnings call.
Year-to-date stock performance: Amgen’s stock is down 1.9%; Adaptive is up 10.3%.
Background: Altimmune Inc. ALT, -14.36% said March 30 it is partnering with University of Alabama at Birmingham to develop a single-dose, intranasal COVID-19 vaccine. They said they plan to put the vaccine candidate into Phase 1 trials in the third quarter. The preclinical company is also developing vaccines for anthrax and the flu.
Year-to-date stock performance: Shares of Altimmune have gone up 60.8%.
BioNTech and Pfizer
Type: mRNA vaccine
Stage: Phase 1/2
Name: BNT162 program
Background: Pfizer Inc. PFE, 3.08% announced March 17 it would help develop and distribute BioNTech SE’s BNTX, 5.42% COVID-19 vaccine candidate, though the deal excludes China. The 360 patients in the U.S. trial had started to receive the first doses of the four vaccine candidates included in the study as of May 5. Dosing in 200 participants in the German trial began April 23. As part of the deal, Pfizer will pay $185 million upfront, with additional possible future milestone payments of up to $563 million. Mikael Dolsten, Pfizer’s chief scientific officer, said during an April 28 earnings call that the companies expect the first round of trial data in May or June, with the vaccine candidate moving into “expanded trials that could allow emergency use or accelerated approval coming in the fall, possibly October.”
BioNTech is also testing the vaccine in collaboration with Shanghai Fosun Pharmaceutical Group Co. Ltd. in China.
Pfizer and BioNTech for several years have said they are working on mRNA-based influenza vaccines.
Year-to-date stock performances: Shares of BioNTech have soared 47.6%; Pfizer’s stock is down 1.7%.
Stage: Phase 2 and Phase 2b/3 clinical trials
Background: CytoDyn Inc. CYDY, -4.42%, a preclinical biotechnology company based in Vancouver, is testing its experimental drug leronlimab in two types of COVID-19 patients. The investigational therapy hasn’t been approved for any indications; for COVID-19, it is being proposed as a treatment for mild-to-moderate respiratory complications that occur in patients with the disease as well as severely and critically ill patients.
The randomized, double-blind, placebo-controlled study will test the efficacy and safety of leronlimab in 75 patients. CytoDyn had been studying experimental therapy as a treatment for people with HIV and a form of metastatic breast cancer.
Year-to-date stock performance: CytoDyn’s stock has soared 213.0%.
Stage: Emergency use authorization
Background: Gilead Sciences Inc. GILD, 0.07% is a longtime drugmaker best known for developing the first major cure for hepatitis-C in Sovaldi, a therapy that changed the standard of care for that disease but also kicked off the national debate about drug pricing. The company has experience developing and marketing HIV drugs, including Truvada for pre-exposure prophylaxis (PrEP), its preventive HIV medicine.
It received an emergency-use authorization from the Food and Drug Administration in the U.S. on May 1 based on preliminary results from two clinical trials: one conducted by the NIAID, and one by Gilead. In the NIAID trial, COVID-19 patients taking the drug had a median recovery time of 11 days, compared with 15 days for those patients taking placebo. NIAID director Dr. Anthony Fauci has said the drug is now considered the standard of care; however, other experts have had mixed responses to the data. Dr. Eric Topol, director of the Scripps Research Translational Institute, said he thinks the drug is effective based on the preliminary data that has been made public. “It’s just not that potent,” he said via email.
The drug was also used in two randomized, controlled clinical trials in China. Results from one trial, which was stopped early, found the drug didn’t produce “statistically significant clinical benefits,” according to findings published in The Lancet.
Gilead in late March had to halt individual compassionate use requests for remdesivir as outbreaks worsened in the U.S., having provided the investigational therapy to 1,000 patients. “The system cannot support and process the overwhelming number of applications we have seen with COVID19,” Gilead CEO Daniel O’Day said March 28.
The company told investors on May 1 it may spend up to $1 billion this year to develop and manufacture remdesivir, and it aims to have 500,000 treatment courses by October and 1 million by the end of 2020.
Gilead’s notable clinical trials:
- The National Institute of Allergy and Infectious Diseases trial has enrolled patients in a randomized, double-blind, placebo-controlled Phase 3 trial evaluating 1,063 hospitalized patients with COVID-19 at 68 sites worldwide, including at three sites in Singapore and South Korea, according to the NIAID. However, the majority of the study locations are in the U.S. The study began Feb. 21 and is expected to conclude April 1, 2023. Preliminary results from this trial were
used to inform the EUA.
- A Gilead-sponsored randomized, open-label Phase 3 trial is testing remdesivir in 1,600 patients with moderate COVID-19. It previously said it would enroll 600 participants. The trial started enrolling patients in March, with results to come in May. The clinical trial listing states the study is taking place in 13 countries, including Hong Kong, Singapore, South Korea and the U.S.
- A Gilead-sponsored randomized, open-label Phase 3 trial is evaluating remdesivir in 6,000 patients with severe COVID-19. The drugmaker previously said it planned to include 400 participants in the trial. The trial started enrolling patients in March, and early results based on 397 patients included in the initial phase of the study were used to inform the EUA. The clinical trial listing states the study is taking place in Hong Kong, Singapore, South Korea and the U.S.
Results: The EUA followed two weeks of clinical trial data leaks that sent the company’s stock soaring or tumbling depending on the news. Stat News reported April 16 that University of Chicago Medicine researchers saw “rapid recoveries” in 125 COVID-19 patients remdesivir, though that data isn’t part of the full clinical trial data set. A week later, Stat and the Financial Times reported that a draft of the clinical trial results for remdesivir showed that the drug didn’t speed up improvement in patients in China or prevent them from dying. The summary was reportedly published by accident on the World Health Organization’s (WHO) website and then taken down.
What’s next: The drugmaker plans to donate 1.5 million vials, about 140,000 10-day courses of treatment, of the drug through June. It also said May 5 that it plans to contract with pharmaceutical manufacturers abroad to ensure access to remdesivir outside of the U.S. The Institute for Clinical and Economic Review, a group that assesses the cost-effectiveness of medicines, said Gilead would need to charge $10 for a course of treatment to recoup its costs, but could be priced as high as $4,500 per course of treatment to be considered effective.
Year-to-date stock performance: Shares of Gilead are up 21.2%.
Type: Vaccine, treatment
Name: AS03 adjuvant system for vaccines
Background: GlaxoSmithKline GSK, -0.19% is another leading vaccine maker, having brought to market vaccines for human papillomavirus (HPV) and the seasonal flu, among others. It has announced a string of wide-reaching collaborations during the pandemic, most notably a deal with Sanofi to jointly develop a vaccine candidate. (Sanofi is also working with BARDA on a separate vaccine program.) As part of this agreement, Sanofi’s S-protein COVID-19 antigen will be paired with GlaxoSmithKline’s adjuvant technology; the companies expect to launch clinical trials in the second half of the year. Terms of the agreement are expected to be completed this month.
Also in the works: GSK said Feb. 3 that the CEPI-funded University of Queensland will have access to its vaccine adjuvant platform technology, which is believed to both strengthen the response of a vaccine and limit the amount of vaccine needed per dose. A separate deal with Clover Biopharmaceuticals Inc., a Chinese biotechnology company, which was announced in February, is also using its adjuvant technology in combination with its vaccine candidate, COVID-19 S-Trimer, in preclinical studies. Dr. Thomas Breuer, chief medical officer for GSK Vaccines, is leading work on vaccines and the adjuvant platform.
Separately, GSK and Vir Biotechnology Inc. announced a deal in early April, in which GSK made a $250 million equity investment in Vir as the two companies work together to develop two of Vir’s experimental therapies, VIR-7831 and VIR-7832, expected to go to Phase 2 clinical trials sometime in 2020.
Year-to-date stock performance: Shares of GSK have tumbled 11.3%.
Background: Heat Biologics Inc. HTBX, 5.56% has previously announced that it is developing a vaccine for the novel coronavirus with the University of Miami Miller School of Medicine. It disclosed March 17 in a financial filing that its COVID-19 vaccine candidate had been added to the World Health Organization’s “draft landscape” of 41 candidate vaccines. “We are finalizing completion of the vaccine and plan to commence preclinical testing this quarter,” Heat CEO Jeff Wolf said in an April 29 statement.
The company also recently joined the Alliance for Biosecurity, which may help it “secure government funding to support its rapid development, production, and distribution” of its COVID19 vaccine, according to Maxim Group analysts.
Year-to-date stock performance: Heat’s stock has gained 14.8%.
Type: DNA-based vaccine
Timeline: Phase 1 clinical trial
Background: Another CEPI grantee (with roughly $17 million in total awards), Inovio Pharmaceuticals Inc. INO, -4.03% is testing its vaccine candidate in a Phase 1 clinical trial at two sites in the U.S.: the Perelman School of Medicine at the University of Pennsylvania and the Center for Pharmaceutical Research in Kansas City, Mo.
Inovio develops immunotherapies and vaccines but hasn’t yet had a product approved for treatment. For INO-4800, preclinical testing was performed between Jan. 23 and Feb. 29. The company began clinical trials in the U.S. with up to 40 participants in April, dosing the first patient on April 6. Inovio said it expects to have the first results from the trial in the fall and to have 1 million doses of the vaccine ready for additional clinical trials or emergency use by the end of the year.
Inovio on March 12 announced a $5 million grant from the Bill & Melinda Gates Foundation to test a delivery device for its vaccine candidate. In late March, Inovio said that Ology Bioservices Inc., a contract development and manufacturing organization, had received a $11.9 million contract from the Department of Defense to support future potential manufacturing of Inovio’s vaccine candidate for military personnel.
Year-to-date stock performance: Shares of Inovio have soared 209.5%.
Johnson & Johnson
Background: Johnson & Johnson JNJ, 0.52% announced Feb. 11 that it was working with BARDA to test its vaccine candidate, with each party providing $1 billion for research and development and the public-health organization funding the Phase 1 trials.
“We are also in discussions with other partners, that if we have a vaccine candidate with potential, we aim to make it accessible to China and other parts of the world,” Dr. Paul Stoffels, J&J’s chief scientific officer, said in a statement.
On March 13, J&J said it started preclinical testing on multiple candidates in collaboration with Beth Israel Deaconess Medical Center in Boston, and by March 30 it had identified a lead vaccine candidate. The company said it is scaling up its vaccine manufacturing capabilities in the U.S. and abroad as part of its commitment to bring “an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use.”
The company aims to put its lead vaccine candidate in a Phase 1 clinical trial in September, the company said March 30, and it may have investigational doses of the vaccine available by early 2021 for emergency use.
Also in the works: J&J said in February that it had partnered with BARDA on a project that aims to screen existing antiviral medications, including experimental or approved therapies, that may be effective against COVID-19. Similar to GSK, J&J’s AdVac and PER. C6 technologies are used to improve the development process for a vaccine and were also used to develop J&J’s experimental Ebola vaccine.
Year-to-date stock performance: Shares of J&J are up 2.6%.
Type: RNA-based vaccine
Stage: Phase 1
Background: Moderna Inc. MRNA, 1.15% received funding from CEPI in January to develop an mRNA vaccine against COVID-19. On Feb. 24, it said it had shipped the first batch of mRNA1273 to the NIAID for a Phase 1 clinical trial in the U.S.
Clinical trials: The first patient in the Phase 1 trial received a dose of the vaccine candidate on March 16. The study is expected to enroll 45 healthy adult patients, between the ages of 18 and 55 years old, in an open-label Phase I clinical trial to test mRNA-1273 as a vaccine for COVID-19. Participants will be followed for one year. The trial, which is expected to conclude June 1, 2021, will be conducted at Kaiser Permanente Washington Health Research Institute in Seattle. CEPI funded the manufacturing of the investigational vaccine for the first phase of the trial, which is evaluating different doses for safety and immune response. A Phase 2 trial is expected to begin in the second quarter.
In mid-April, Moderna said it will receive up to $483 million in BARDA funding to support its vaccine development program. “We believe that we would be able to supply millions of doses a month in 2020 and with further investments, tens of millions a month in 2021, if the vaccine candidate is successful in the clinic,” Moderna CEO Stéphane Bancel said at the time.
Year-to-date stock performance: Moderna’s shares have gained 146.8%.
Stage: Phase 1 clinical trial
Background: Novavax Inc. NVAX, 1.28%, a preclinical biotechnology company, announced Feb. 26 that it had several vaccine candidates in preclinical animal studies. By April 8, the company said it had identified a COVID-19 vaccine candidate, and it plans to initiate a Phase I clinical study in mid-May. The first phase of the placebo-controlled study will enroll 130 healthy adults; the first round of data from that study is expected in July.
In March the company said it had received $4 million from CEPI to develop a COVID-19 vaccine and that Emergent BioSolutions Inc. would support contract development and manufacturing for the experimental vaccine.
Year-to-date stock performance: Its stock has gained 334.4%.
Type: Prevention and treatment
Background: On Feb. 4, Regeneron Pharmaceuticals Inc. REGN, -1.89% announced it is working on developing monoclonal antibodies as treatments for COVID-19, and during a May 5 earnings call it disclosed the name of the treatment, REGN-COV2. The company’s VelocImmune platform uses genetically engineered mice with humanized immune systems in preclinical testing. “We are aiming to have hundreds of thousands of prophylactic doses ready for human testing by the end of August,” a spokesperson said. Christos Kyratsous, vice president of infectious disease R&D and viral vector technology, is running the project.
Clinical trials are expected to begin in June.
Year-to-date stock performance: Regeneron’s shares are up 37.0%.
Regeneron Pharmaceuticals and Sanofi
Stage: Phase 2/3 clinical trial
Background: The FDA approved Kevzara, a treatment developed by Regeneron and Sanofi SNY, -0.26%, as a therapy for rheumatoid arthritis in 2017 as part of a recently concluded longstanding R&D partnership between the two companies.
Clinical trials: Regeneron and Sanofi said March 16 they had started a Phase 2/3 trial testing Kevzara as a treatment for patients who have been hospitalized with severe COVID-19 infections. This randomized, double-blind, placebo-controlled trial is expected to enroll up to 400 patients and will take place at 16 sites in the U.S. New York’s Mount Sinai Hospital, the first site, has started enrolling patients, according to a company spokesperson.
The aim is to evaluate if the drug lessens patient fevers and their need for supplemental oxygen. The Phase 3 trial will evaluate if Kevzara prevents deaths and reduces need for mechanical ventilation, supplemental oxygen, or hospitalization. Early results from a small 21-person trial in China that haven’t been peer-reviewed found that some patients who were taking a similar drug, Roche Holdings’ Actemra, reported reductions in fever, and 7% of them had a reduced need for supplemental oxygen within days of starting treatment.
Results: On March 30, the companies said the first patient in their global trial had been treated. However, in late April, the companies said they would limit the Phase 3 trial to only include patients defined as critical, which includes those requiring mechanical ventilation, high-flow oxygenation, or being cared for in an intensive care unit, given that sicker patients seemed to show some improvement while taking the drug. The next phase of the study will also only include a higher dose of the drug (400 milligrams) and the placebo, and not the lower dose of 200 milligrams
used in the mid-stage trial.
Stage: Phase 3 clinical trial
Background: Roche Holdings AG’s ROG, +1.01% Actemra was first approved in 2010 as a rheumatoid arthritis drug. The Swiss drugmaker has initiated a Phase 3 clinical trial evaluating Actemra as a treatment for patients with COVID-19 who have been hospitalized with severe pneumonia. Roche began enrolling around 330 patients in early April, at 55 sites in the U.S. and elsewhere in the world. The company plans to examine patient mortality and need for mechanical ventilation or an intensive care unit stay among other primary and secondary endpoints. On April 3, the first patients in the trial, which is in partnership with BARDA, were treated, a Roche spokesperson said by email. Results are expected in early summer, the company said April 22.
Also in the works: Roche has developed a diagnostic and an antibody test for COVID-19. Both have received EUAs from the FDA.
Year-to-date stock performance: Roche’s stock is down 1.3%.
Name: No name yet
Background: Starting Feb. 18, Sanofi is working with BARDA to test a preclinical vaccine candidate for severe acute respiratory syndrome (SARS) for COVID-19 using its recombinant DNA platform. A spokesperson said Sanofi aims to put a vaccine into a Phase 1 clinical trial between March 2021 and August 2021. It announced a separate program with Translate Bio Inc. TBIO, 1.30% on March 27 to develop a mRNA vaccine.
The French drugmaker has a long history of producing vaccines in its Sanofi Pasteur business and acquired this candidate through its 2017 acquisition of Protein Sciences for $750 million. It previously worked with the organization on flu vaccines. Scientists in Meriden, Ct., are working on the vaccine; David Loew, Sanofi Pasteur’s EVP, is leading the project.
Year-to-date stock performance: Shares of Sanofi are down 0.7%.
Type: Antibody treatment
Background: Japanese drugmaker Takeda Pharmaceutical Co. Ltd. TAK, 2.09% 4502, +2.89% said March 4 that it plans to test hyperimmune globulins for people who are at high risk for infection.
As part of its research, which will be performed in Georgia, Takeda said it would need access to plasma from people who have recovered from COVID-19 or those who have received a vaccine if one is developed. Dr. Rajeev Venkayya, president of Takeda’s vaccine business, is the co-lead of the company’s COVID-19 response team. In April, Takeda and CSL Behring CSLLY, -0.98% said they formed an alliance to develop a plasma-derived treatment for COVID19. Biotest AG and Octapharma also joined the alliance.
Also in the works: Like J&J, Takeda plans to examine whether other therapies, both experimental or with regulatory approval, may have treatment potential.
Year-to-date stock performance: Shares of Takeda are down 10.0%.
Background: Vaxart Inc. VXRT, -6.21% was one of the first companies to announce plans to develop a vaccine when it did so Jan. 31. In March, the clinical-stage company announced that Emergent BioSolutions will help develop and manufacture its oral vaccine candidate.
“We believe an oral vaccine administered using a room temperature-stable tablet may offer enormous logistical advantages in the rollout of a large vaccination campaign,” Vaxart CEO Wouter Latour said in a March 18 news release.
The company plans to start a Phase 1 clinical trial in the U.S. in the second half of 2020, a company executive said. As of March 31, it has five vaccine candidates for preclinical testing.
Year-to-date stock performance: Vaxart’s stock is up 621.8%.
Name: VIR-2703 (also called ALN-COV), VIR-7831 and VIR-7832
Background: Vir Biotechnology Inc. VIR, -0.74% has two preclinical treatment candidates, VIR7831 and VIR-7832, and on May 4 said it had identified a treatment candidate as part of a partnership with Alnylam Pharmaceuticals Inc. ALNY, -2.48%. The companies said they aim to file for an investigational new drug application by the end of 2020, before the proposed inhaled treatment or prevention therapy would enter trials.
Also in the works: In many ways, Vir has been one of the most prolific partners in the biotech field during the pandemic. The preclinical company is run by George Scangos, the former CEO of Biogen Inc. BIIB, 1.36%. Starting Feb. 25, it said it was collaborating with Shanghai-based WuXi Biologics to test monoclonal antibodies as a treatment for COVID-19. If the treatment is approved, WuXi will commercialize it in China, while Vir will have marketing rights for the rest of the world. It later announced a partnership with Biogen to help develop and manufacture its monoclonal antibodies as a potential treatment for COVID-19. Biogen will handle clinical manufacturing of Vir’s antibodies, the company said. Vir later announced a research agreement with Generation Bio as part of its COVID-19 antibody development program. Most recently, it announced the equity investment from GSK.
Year-to-date stock performance: Vir shares have jumped 138.2%.
Competition on the global market for COVID-19 vaccine development (Current State)
As of November 30, 2020, there were around 960 drugs and vaccines in development targeting the coronavirus disease (COVID-19). American company ImmunoPrecise Antibodies was ranked second among companies worldwide with nine drugs/vaccines in development targeting COVID19.
As of December 3rd 2020, the world reported over 65 million cases of the coronavirus disease (COVID-19), resulting in more than 1.5 million deaths. After some relaxing during summer, many countries are now facing the full force of the pandemic’s second wave. The call for vaccines and treatments is louder than ever, especially with respect to the cold season in the northern hemisphere when the novel coronavirus is expected to spread much easier as people spend more time indoors.
Finding a safe and effective vaccine is a global health priority. Other than potentially dangerous herd-immunity by natural infection, for many experts it is the only true game-changer in this pandemic. Being the first company to produce a vaccine against the new disease is a matter of prestige and, even more so, a matter of potentially high profits. Not only the established big pharma companies, but also small innovative biotech firms are racing to create a vaccine against the new coronavirus. Several such companies have already increased their market capitalization as a result of being involved in research on SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2 – the virus that causes the COVID-19 disease).
Good news in November
On November 9th, Pfizer and BioNTech announced that their vaccine BNT162b2 was 90% effective in protecting from COVID-19. After more evidence from the trials came in, the efficacy rate was corrected to even 95%. Thus, the American-German cooperation was the first project with preliminary evidence from phase III in clinical trials. This would facilitate the production of the first 50 million doses of the vaccine until year-end, and then another 1.3 billion doses during 2021. Only a week after the announcement of BioNTech/Pfizer, U.S. biotech company Moderna also reported that phase III trials of its vaccine showed an outstanding 95 percent efficacy. The company indicated that first doses for risk groups could be ready during December. Both vaccines are using mRNA technology and would be the first vaccines of this kind ever brought to market. As of early December, applications for (emergency) approval have already been submitted in the U.S. and in Europe.
Comparison of the COVID-19 vaccines developed by BioNTech/Pfizer and Moderna as of November 2020
In November 2020, COVID-19 vaccines from the Biontech/Pfizer cooperation and from Moderna showed very good results in phase III of clinical trials. Both sites reported nearly the exact same efficacy of around 95%. Pfizer and BioNTech will probably be able to produce larger amounts until year-end 2020 and also during 2021.
Progress and setbacks for the AstraZeneca / Oxford vaccine
AstraZeneca added to the positive news on November 23. The company reported that its vaccine – developed in partnership with Oxford University – showed a 62-90 percent efficacy in phase III. Although the efficiency is significantly lower, AstraZeneca’s vaccine could be the favorite for widespread usage around the world. While the vaccines developed by Moderna and especially Pfizer need a strict and sophisticated ultracold supply chain that has yet to be established, AstraZeneca’s vaccine can be stored at normal refrigerator temperature. Therefore, it would be far more attractive for remote areas and poorer countries. However, scientists had difficulty understanding the big range in efficacy and the fact that patients with a lower dose showed the most protection. AstraZeneca later admitted dosing errors in the trial. The company was also criticized for combining the results of the low-dose and full-dose groups to reach an average efficacy of 70%, even though the groups were not comparable by size or age distribution. There were further setbacks to hit the late-stage clinical trials of the AstraZeneca/Oxford project. One patient developed severe neurological symptoms, while another volunteer died in Brazil. The trial continued, however, because the deceased patient was believed to be part of the placebo group. As of now, it looks like AstraZeneca will need more time and more evidence to bring its vaccine to the market.
Early frontrunners in the race for a vaccine
From the very beginning of COVID-19 vaccine research, Moderna‘s mRNA-1273 probably was the most mentioned vaccine in development. It has been developed by Moderna Inc. in partnership with the National Institute of Allergy and Infectious Diseases (NIAID). Considering how slow drug development can be, the new vaccine was ready in record time, far quicker than drugs manufactured during previous pandemics. This was made possible mostly by significant scientific advances in recent years.
The mRNA-1273 vaccine was the first vaccine worldwide given to healthy humans. The urgent situation means that regulators have started to grant emergency approvals for diagnostics, vaccines, and treatments. After Moderna, CanSino Biologics from China was the second company which started running clinical tests in healthy volunteers. The trio of top frontrunners was completed by a team at the Oxford University partnered by AstraZeneca.
A surprise from Russia
On August 11th, Russia’s president Putin announced that his country was the first to have a vaccine ready to be administered to COVID-19 patients. As a way of showing total confidence in the vaccine called “Sputnik V“, he informed the media that one of his daughters had already received a dose. Scientists from outside Russia have reacted with skepticism. Not only was clinical trial phase II performed with only 76 participants, but phase III results were skipped completely. Phase III began only in September with approximately 40,000 volunteers, according to Russian sources. But as of November, the first results of the late-stage trial showed that the Sputnik V vaccine had a high efficacy, ranging from 92-95 percent. While several countries around the world have preordered the vaccine, Western countries remain skeptical, stating a lack of peer-reviewed evidence from the trials in Russia so far.
The case of Novavax
Today, Novavax is slated to receive up to $2 billion from the U.S. government and a nonprofit organization to develop and manufacture a coronavirus vaccine. The company’s stock closed at $80.71 per share on 30 October, it has hired more than 300 new employees, and this month it plans to launch a pivotal clinical trial of its coronavirus vaccine in the United States and Mexico. Made by moth cells harnessed to crank out the virus’ spike protein – which the pathogen uses to invade human cells – Novavax’s vaccine outshone major competitors on key measures in monkey and early human tests.
The company is one of just seven vaccine makers to win funding so far from Operation Warp Speed, the giant multi agency U.S. government effort aiming to quickly produce at least 300 million doses of COVID-19 vaccines. But most Warp Speed-backed companies are giant pharmaceutical firms, and most have already launched late-stage clinical trials in the United States. Tiny Novavax is rushing to keep pace with its larger rivals because companies that win the first approvals from regulators will have big market advantages. Still, some observers say Novavax’s technology gives it an edge.
“They are incredibly well positioned”, says Andrew Ward, a structural biologist at Scripps Research. Ward, who receives no payments from the company but owns some stock, led a team that last month published a paper in Science describing the structure of Novavax’s tailor made spike protein, the heart of its vaccine. He was impressed by its stability and conformation, as well as the vigorous antibody responses it has elicited in humans and animals. “They have the knowhow,” he says. “And they obviously, as we confirmed, make a good product.”
But other people are skeptical. They note that Novavax has focused on making vaccines for more than 20 years but has never brought one to market, and that its senior executives have sold tens of millions of dollars of company stock since its share price began to soar this summer.
Glenn and other Novavax scientists had spent years developing “protein subunit” vaccines, so named because they employ a protein (or part of one) from the targeted virus, plus an immuneboosting compound called an adjuvant, to provoke an immune response. The company hadn’t had a commercial success – its vaccine against a serious respiratory illness failed in clinical trials. But it had produced a promising flu vaccine aimed at older adults, which was nearing the end of a pivotal trial. The company had also created protein subunit vaccines against two close cousins of the pandemic virus – the coronaviruses that cause severe acute respiratory syndrome and Middle East respiratory syndrome, using those viruses’ spike proteins. Those vaccines hadn’t made it to market, but Novavax had plenty of experience with the coronavirus family. Glenn believed it was his company’s moment.
The company’s scientists started to work “with frenetic pace”, Glenn says. Some of their competitors were already a lap ahead, working on their own vaccines. “There’s no question [that we’re] behind” several companies that also won Warp Speed funds, Glenn said on the morning of 24 September, the day Novavax launched its first phase III trial, of 15,000 volunteers in the United Kingdom.
Most of Novavax’s key competitors – Moderna, Pfizer, Johnson & Johnson subsidiary Janssen, and AstraZeneca – had launched phase III trials by then. To make their vaccines, all four of those firms use new technologies based on genetic material that directs protein production, rather than delivering proteins directly. Those platforms rely on DNA loaded in disabled viruses or on messenger RNA to carry genetic instructions for building the spike protein. Cells within a
vaccinated person then churn out the protein, alerting the immune system.
Perhaps because the technology is tried and true, scores of other companies are also racing to develop protein subunit vaccines. Novavax is the only one to have launched a phase III trial. Of the other firms, the huge vaccine maker Sanofi Pasteur is likely Novavax’s biggest rival. It “is going to be formidable competition to the Novavax vaccine,” says Vijay Samant, a former head of vaccine manufacturing at Merck and now a consultant to vaccine companies. (Novavax is not a client.) Sanofi Pasteur has deep pockets, infrastructure, and experience, and markets vaccines against 19 infectious diseases.
Stock Market Performance
In this section there are presented the key indicators of the stock market performance of the best COVID – 19 vaccine developers.
Market value: $24.8 billion
Performance since market peak: +252.5%
- Gilead Sciences
Market value: $95.8 billion
Performance since market peak: +13.2%
Market value: $2.5 billion
Performance since market peak: +448.8%
- Inovio Pharmaceuticals
Market value: $2.1 billion
Performance since market peak: +252.5%
Market value: $159.9 billion
Performance since market peak: -3.6%
- Regeneron Pharmaceuticals
Market value: $64.9 billion
Performance since market peak: +43.9%
Market value: $102.6 billion
Performance since market peak: -5.9%
Market value: $468.4 million
Performance since market peak: +467.1%
Market value: $12.8 billion
Performance since market peak: -10.1%
- Kimberly – Clark
Market value: $47.2 billion
Performance since market peak: -3.6%
After analyzing the official news and statistics about coronavirus vaccine development, the author has concluded that the companies that have more chances to succeed on the global health challenge and that will be the most profitable are as follows.
- Pfizer is the well known American pharma company that has signed a joint venture agreement with the german company – BioNTech. Their collaboration – BNT162b2 seems to be recognized as one of the most potential one to lead the competition of the coronavirus vaccine. The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by
the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 16 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist
justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Find the details of the vaccine of COVID-19 at this link.
- Moderna – On October 22nd, Moderna completed enrollment of the Phase 3 study of mRNA-1273. Then later on November 16th, Moderna announced a longer shelf life for mRNA-1273 at refrigerated temperatures. mRNA-1273 met its primary efficacy endpoint in the first interim analysis of the Phase 3 COVE study with a vaccine efficacy of 94.5%.
Thoroughly observing the current situation, it is noticed that the strongest competition appears in the USA. There is a geographical concentration of the companies that are working on COVID-19 vaccine development in the USA. America obviously seems to be a leading market in the most important global healthcare challenge of the new millennium. So, as the result of all analyses even though Pfizer and BioNTech are going to be both successful in the competition, investing in Pfizer is going to be more profitable as far as the competition in the USA is very strong. Due to the
innovation and R&D incented by the competitive environment, Pfizer is somehow more in pressure to keep the excellence than BioNTech is. However, BioNTech stocks seem to be less riskier than those of Pfizer.