<Weekly Highlight>
States restart J&J Covid-19 vaccine, previously paused over blood-clotting side effect[1] (4/25)
The CDC and FDA lifted the pause of J&J vaccines after a vote by the advisory panel on 4/23, saying the benefits outweigh the risks. J&J and regulators plan to add language to the shot’s label and fact sheets warning of the clotting condition risk.
The J&J vaccines was able to resume the following weekend (4/24-25) because millions of doses had already been distributed. A CDC official said if the J&J vaccinations resumed, it could prevent up to 1,400 deaths and up to 3,500 admissions to hospital intensive-care units over 6 months. However, there could be up to 45 cases of rare blood-clot condition.
The rare clot condition was about 1.9 cases per million people overall; 7 cases per million for women ages 18-49; 0.9 per million for women over 50.
The availability of J&J vaccines could ease supply constraints that have cropped up since its pause at areas and vaccination sites. It could also fulfill demand among people who prefer to get a single shot.
European health regulators also have investigated the clot risk and decided that vaccination can proceed but with a product information that carry a warning of the rare clot risk. The European Medicines Agency said the benefits of the vaccine outweigh its risk.
<COVID-19 News>
Bharat Biotech aims for 700M COVID-19 shots per year with government cash and partners[2] (4/20)
Bharat Biotech and the Serum Institute of India received hundreds of millions of dollars from India’s government to boost COVID-19 vaccine production.
Bharat plans to upgrade at two plants to boost production of its vaccine, Covaxin, to nearly 700 million doses a year. It is expected to double its vaccine output by June and produce around 100 million doses per month by September.
Major pharmacies ramp up supply of over-the-counter COVID-19 tests[3] (4/21)
A rapid antigen COVID-19 at-home test, named BinaxNOW by Abbott Laboratories, were sent to CVS, Walgreens, and Walmart stores across the country starting 4/19.
BinaxNOW will be sold at $23.99 at most locations, both online and in stores. It uses a nose swab to detect COVID-19 and provides results within 15 minutes.
There are other non-prescription COVID-19 tests available as well:
$38.99 test kit by Ellume delivers the result to a smartphone app within 15 minutes.
The “Pixel” by Labcorp Home Collection Kit is a PCR test that requires users to ship their test kit to a blab, with results typically available within one to two days of receipt.
Lucira Health’s “Check It” kit includes a battery-powered testing device to process nasal swap samples and returns results within 30 minutes.
Lucira Health has signed to provide its tests at no cost to NBA ticketholders heading to the major game in San Francisco on April 23. The use of the kit is voluntary. [4]
FDA finds poor conditions at contractor’s plant for making J&J’s Covid-19 vaccine[5] (4/21)
FDA Inspector found the plant of Emergent BioSolutions, the contract manufacturer for J&J vaccines, didn’t maintain clean and sanitary conditions and didn’t follow procedures to prevent contamination.
Among the problems identified was cross-contamination of two different vaccines in production at the plant. The names were not given, but it was presumed to be J&J and AstraZeneca’s COVID-19 vaccines.
The plant recently had a contamination-related incident that ruined a batch of the main ingredient for J&J’s COVID-19 vaccine in early April. No doses were distributed from that batch, and the FDA hasn’t authorized doses from Emergent plant to be distributed.
Pfizer identifies fake Covid-19 shots abroad as criminals exploit vaccine demand[6] (4/21)
Pfizer identified the first confirmed instances of fake COVID-19 vaccines in Mexico and Poland.
The vials seized by authorities were tested by Pfizer and was confirmed to contain bogus vaccine. The vials from Mexico also had fraudulent labeling, and a substance inside vials in Poland was likely an antiwrinkle treatment.
About 80 people at a clinic in Mexico received a fake vaccine for about $1,000 a dose, but they don’t appear to have been physically harmed. No one received the fake vaccine in Poland as it was seized at a man’s apartment.
The findings are the latest in joint effort between law enforcement and pharmaceutical companies such as Pfizer, Moderna Inc. and Johnson & Johnson to stem criminal activity related to the Covid-19 vaccines. The global rollout of shots has provided criminals a fresh opportunity to take advantage of unsuspecting people.
AstraZeneca still plans to seek US approval of its COVID-19 vaccine[7] (4/21)
AstraZeneca is still planning to apply for emergency use authorization (EUA) of its COVID-19 vaccine in the US despite the company’s vaccine having been vilified and its manufacturing network questioned.
AstraZeneca succeeded in Phase 3 testing in March and had planned to apply for EUA earlier in April.
The product has showed more than 100 cases of rare and severe blood clots with at least 37 fatalities.
The vaccine data was questioned by the FDA because AZ said the shot was 79% effective at first but changed it to 76% days later.
EU is currently preparing legal action against AZ for failing to provide its promised supply of vaccine doses to EU. AZ originally committed to sending Europe 90 million doses by March but has been lowered to 30 million due to struggles to get its supply chain up to speed. [8]
Many EU countries and Canada recommended the continuous use of AZ vaccine because the benefits outweigh the risks.
Inovio’s COVID-19 vaccine funding cut as US vaccinations pick up[9] (4/23)
The US has seized funding on the phase 3 trial for Inovio’s vaccine because another vaccine is no longer needed as vaccinations pick up around the country.
Inovio was hoping to offer a vaccine that would be stable at room temperature for up to a year to address the issues of cold storage requirements. However, the world figured out the storage problem and more than a quarter of all Americans are now fully vaccinated, leaving little room for Inovio’s product.
Valneva kickstarts phase 3 COVID-19 vaccine, competing against AstraZeneca[10] (4/23)
Valneva, a French biotech partnered with Dynavax Technologies Corporation, a US biopharmaceutical company, has started a pivotal phase 3 test for its experimental COVID-19 vaccine against AstraZeneca’s conditionally approved vaccine.
The trial takes place in UK and it intends to make regulatory submission in the Fall of 2021.
The company announced on April 12 that it was seeking a Nasdaq IPO worth $100 million.
<Industry News>
TG Therapeutics prepares multiple sclerosis drug for FDA review[11] (4/19)
TG Therapeutics announced that its experimental drug ublituximab reduced the annual relapse rate in multiple sclerosis (MS) by up to 60% more than Sanofi’s Aubagio in phase 3 trials. TG expects to submit the drug for use in MS by September.
The drug is currently under FDA review for use in Leukemia.
If approved, it would become the third MS drug cleared that works by targeting a protein found on B cells after Roche’s Ocrevus and Novartis’ Kesimpta.
A record number of biotechs are going public[12] (4/21)
IPO markets weren’t receptive to biotech companies until 2013 when public investment was pouring into the industry, drawn by scientific advances and boosted by the newfound interest of a broader range of investors.
Many young pharmaceutical companies, even those that are still years from human trials, have gone public at valuations never though possible in the 2000s. In 2020, a record was set for a number of biotech IPOs.
List of biotech IPOs can be found in this link.
Biden Administration’s tax plan is hitting tech and pharma companies, and J&J cautions against higher corporate tax rate (4/21)
Biden’s tax plan laid out in early April will hit the technology and pharmaceutical companies particularly hard because the two industries’ assets are mostly intellectual property (IP), and such intangible assets make it easier for them to structure global operations to minimize tax costs. [13]
Pharma and biotech companies faced benefits under Trump’s previous tax reform act. However, with Democrats in office, a higher corporate tax rate is expected and is presumed to help pay for Biden’s infrastructure plan.
Johnson & Johnson is the first big pharma to speak out against Biden’s tax plan, expressing that a higher rate would threaten investment and innovation in the US.[14]
Biogen’s Alzheimer’s drug prepares for an uncertain launch as the FDA review is nearing[15] (4/22)
Biogen’s Alzheimer’s drug aducanumab, is pending FDA’s decision by June 7, 2021, but it is uncertain whether FDA will give approval or rejection due to controversial supporting data.
The drug, if approved, would be a first-of-its-kind therapy to slow the progression of Alzheimer’s disease.
The FDA had previously rejected the approval in November 2020, due to insufficient evidence that supports the drug’s effectiveness.
Doctors expect aducanumab to be met with high demand from patients as there are currently no available treatments to reduce the cognitive decline caused by Alzheimer’s. However, doctors also expect many patients will not be able to access the drug because of FDA restrictions and pushback from insurance companies over a high-priced therapy.
FDA Approves GSK’s immunotherapy for endometrial cancer with specific biomarker[16] (4/22)
The FDA granted accelerated approval to Jemperli (dostarlimab) by GSK for treating patients with recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing chemotherapy and whose cancers have a specific genetic feature known as dMMR (which contain abnormalities that affect the proper repair of DNA inside the cell).
This immunotherapy was specifically studied to target dMMR endometrial cancer and leverages scientific knowledge surrounding the mechanism of immunotherapy response in this unmet medical need population.
This approval shows FDA’s progress in applying precision medicine to expand treatment options for cancer patients.
FDA Authorizes Marketing of Device to Facilitate Muscle Rehabilitation in Stroke Patients[17] (4/23)
FDA authorized marketing of a new device indicated for use in patients 18+ undergoing stroke rehabilitation to facilitate muscle re-education and for maintaining or increasing range of motion.
The device IpsiHand Upper Extremity Rehabilitation System (IpsiHand System) is a Brain-Computer-Interface (BCI) device that assists in rehabilitation for stroke patients with upper extremity disability.
This device fills an unmet need for patients who may not have access to home-based stroke rehabilitation technologies.
<Policies & Announcements>
HHS announces commitments from partners to encourage Latino consumers to enroll in health insurance coverage[18] (4/19)
Department of Health and Human Services (HHS) announced commitments from national organizations to support Latino outreach and enrollment efforts during the current Special Enrollment Period (SEP).
Access to affordable health coverage and care is particularly important for Latinos in the US because 22% of non-elderly Latinos are uninsured, a rate almost 2.5 times that of White Americans.
The American Rescue Plan previously increased tax credits available to millions of consumers, reducing premiums and giving consumers access to affordable, quality health care coverage.
HHS Announces the Largest Ever Funding Allocation for Navigators and Releases Final Numbers for 2021 Marketplace Open Enrollment[19] (4/21)
Today, the U.S. Department of Health and Human Services (HHS) announced that to continue its efforts to increase access to enrollment assistance for consumers, the Centers for Medicare & Medicaid Services (CMS) will make $80 million available in grants to Navigators in Federal Marketplaces for the 2022 plan year.
Navigators are a network of trained individuals that help consumers review their health coverage options as well as complete eligibility and enrollment forms. They serve an important role in connecting communities that historically have experienced lower access to health coverage and greater disparities in health outcomes to health coverage.
The funding, which will be used for outreach and education efforts, is the largest allocation CMS has made available for Navigator grants to date.
HHS Launches ‘We Can Do This: Live’ Initiative to Increase COVID-19 Vaccine Confidence[20] (4/22)
As part of the Biden-Harris Administration’s “We Can Do This” public education campaign to increase confidence in the COVID-19 vaccines and encourage vaccination, the Department of Health and Human Services (HHS) is launching a new initiative today to connect Americans with facts and information on vaccines from doctors, scientists, and health professionals through high-impact digital platforms.
Research shows that Americans want to ask questions about the vaccine directly to health care professionals, so HHS is launching the “We Can Do This: Live” series to pair experts to meet with people.
Events will include conversations to answer direct questions about COVID-19, Instagram Live Q&As, and social media account takeovers where doctors, scientists and health officials can provide the public with factual, scientific information about vaccines.
The Biden Administration has invested nearly $10 billion on the ad campaign to increase vaccine confidence.
Government of Canada invest in the Vaccine and Infectious Disease Organization[21] (4/23)
The Government of Canada has long supported the University of Saskatchewan’s Vaccine and Infectious Disease Organization’s (VIDO) cutting-edge work in the discovery and development of vaccines for some of the world’s most infectious diseases.
In Budget 2021, the government’s plan to finish the fight against COVID-19 and ensure a robust economic recovery that is inclusive of all Canadians, the government proposed a $59.2 million commitment to VIDO to support the development of COVID-19 vaccine candidates and expand the facility.
The funding would allow VIDO to conduct clinical trials for two COVID-19 vaccine candidates, which are currently under development.
Studies announced by the NIH:
(4/23) NIH establishes new childhood asthma clinical research network to conduct pediatric asthma research in low-income urban settings.[22]
(4/23) COVID-19 vaccine responses to be studied in people with immune deficits[23]
(4/22) Medical records analysis links cannabis use disorder in pregnancy to infant health problems[24]
(4/22) Clinical trial of therapeutics for severely ill hospitalized COVID-19 patients begins[25]
(4/21) Large NIH clinical trial will test polyclonal antibody therapeutics for COVID-19[26]
[1]https://www.wsj.com/articles/johnson-johnsons-covid-19-shot-set-to-be-given-again-at-vaccination-sites-11619293517 https://www.fda.gov/news-events/press-announcements/fda-and-cdc-lift-recommended-pause-johnson-johnson-janssen-covid-19-vaccine-use-following-thorough [2]https://www.fiercepharma.com/manufacturing/bharat-biotech-government-cash-hand-aims-for-700-million-covid-19-vaccines-per-year [3]https://www.ny1.com/nyc/all-boroughs/news/2021/04/21/cvs-walgreens-walmart-covid-tests-no-prescription [4]https://www.fiercebiotech.com/medtech/lucira-health-sets-a-pick-covid-19-free-at-home-rapid-tests-for-some-nba-ticketholders [5]https://www.wsj.com/articles/fda-finds-poor-conditions-at-contractors-plant-for-making-j-js-covid-19-vaccine-11619013558 [6]https://www.wsj.com/articles/pfizer-identifies-fake-covid-19-shots-abroad-as-criminals-exploit-vaccine-demand-11619006403 [7]https://www.fiercepharma.com/pharma/astrazeneca-still-plans-to-apply-for-authorization-its-covid-19-vaccine-u-s [8]https://www.fiercepharma.com/pharma/eu-preps-legal-action-against-astrazeneca-for-covid-19-vaccine-shortage-report [9]https://www.fiercebiotech.com/biotech/inovio-s-covid-19-vaccine-funding-axed-as-us-says-thanks-but-no-thanks [10]https://www.fiercebiotech.com/biotech/valneva-kickstarts-dynavax-partnered-phase-3-pitting-its-covid-vaccine-against-astrazeneca [11]https://www.biopharmadive.com/news/tg-therapeutics-multiple-sclerosis-ublituximab/598630/ [12]https://www.biopharmadive.com/news/biotech-ipo-performance-tracker/587604/ [13]https://www.treasuryandrisk.com/2021/04/08/biden-tax-plan-seen-hitting-tech-and-pharma-companies/?slreturn=20210323153105 [14]https://www.fiercepharma.com/pharma/higher-corporate-tax-rates-johnson-johnson-ceo-gorsky-s-not-board [15]https://www.biopharmadive.com/news/biogen-aducanumab-review-uncertain-launch/598890/ [16]https://www.fda.gov/news-events/press-announcements/fda-approves-immunotherapy-endometrial-cancer-specific-biomarker https://www.biopharmadive.com/news/gsk-jemperli-immunotherapy-fda-approval/598962/ [17]https://www.fda.gov/news-events/press-announcements/fda-authorizes-marketing-device-facilitate-muscle-rehabilitation-stroke-patients [18]https://www.hhs.gov/about/news/2021/04/19/hhs-announces-commitments-from-partners-to-encourage-latino-consumers.html [19]https://www.cms.gov/newsroom/press-releases/hhs-announces-largest-ever-funding-allocation-navigators-and-releases-final-numbers-2021-marketplace [20]https://www.hhs.gov/about/news/2021/04/22/hhs-launches-we-can-do-this-live-initiative-increase-covid-19-vaccine-confidence.html [21]https://www.canada.ca/en/innovation-science-economic-development/news/2021/04/government-of-canada-invests-in-the-vaccine-and-infectious-disease-organization.html [22]https://www.nih.gov/news-events/news-releases/nih-establishes-new-childhood-asthma-clinical-research-network [23]https://www.nih.gov/news-events/news-releases/covid-19-vaccine-responses-be-studied-people-immune-deficits [24]https://www.nih.gov/news-events/news-releases/medical-records-analysis-links-cannabis-use-disorder-pregnancy-infant-health-problems [25]https://www.nih.gov/news-events/news-releases/clinical-trial-therapeutics-severely-ill-hospitalized-covid-19-patients-begins [26]https://www.nih.gov/news-events/news-releases/large-nih-clinical-trial-will-test-polyclonal-antibody-therapeutic-covid-19