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2019 was a good year for the pharma industry, even as questions on value kept coming; but 2020 brought a pandemic that raised an “all hands on deck” attitude as well as business challenges.

The first presidential debate of 2020 was marked by the distinct lack of decorum displayed by the incumbent President Trump, but the debate, such as it was, brought up his handling of the COVID-19 pandemic. Joe Biden roundly criticized the president’s performance, and then Trump once more brought up his assertion that a vaccine against SARS-CoV-2 would be available by Nov. 1.

The day of the debate, seven former FDA commissioners – Robert Califf, Scott Gottlieb, Margaret Hamburg, Jane Henney, David Kessler, Mark McClellan and Andy von Eschenbach – wrote an opinion piece in the Washington Post (Kessler is an adviser to the Biden campaign, Gottlieb serves on the board of Pfizer, and McClellan serves on the board of J&J).

The commissioners were imploring that the White House stay out of making any rules about how the safety and benefits of a COVID-19 vaccine will be judged. “Following defined practice, each vaccine clinical trial will continue until independent oversight boards and the sponsoring manufacturers stop them,” the commissioners stated. “The FDA has already effectively communicated its strict standard for evidence from these trials to the manufacturers, despite comments from the White House.”

And looking at the reports, pipelines, and comments from the companies profiled in this issue that are trying to create COVID-19 vaccines – AstraZenecaGlaxoSmithKlineJohnson & JohnsonPfizer, and Sanofi – any chance that a COVID-19 vaccine would be available by Nov. 1 is tenuous at best. A vaccine will probably not be approved until the end of 2020 at the earliest and even if so, would not be broadly available until the middle of 2021.

The debate highlighted how there has been increasing political pressure, particularly in the United States, to get a vaccine out sooner than later. In September, the CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck & Co., ModernaNovavax, Pfizer, and Sanofi signed a pledge vowing to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines. 

The CEOs promised that their companies would always make the safety and well-being of vaccinated individuals their top priority; continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes; only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase III clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA; and work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.

“We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved,” the CEOs said.

The race for a vaccine

In April, AstraZeneca announced that it had entered a collaboration with Oxford University to produce the university’s recombinant adenovirus vaccine aimed at preventing COVID-19 infection from SARS-CoV-2. 

AstraZeneca is responsible for the worldwide manufacturing and distribution of the vaccine, ChAdOx1 nCoV-19, now known as AZD1222. The vaccine uses a viral vector based on a weakened version of the common cold (adenovirus) containing the genetic material of SARS-CoV-2 spike protein. 

In June, AstraZeneca reached an agreement with Europe’s Inclusive Vaccines Alliance (IVA), spearheaded by Germany, France, Italy and the Netherlands, to supply up to 400 million doses of the University of Oxford’s COVID-19 vaccine, with deliveries starting by the end of 2020. The company had already reached agreements with the United Kingdom, the United States, the Coalition for Epidemic Preparedness Innovations, and Gavi the Vaccine Alliance for 700 million doses, and it agreed to a license with the Serum Institute of India for the supply of an additional 1 billion doses, principally for low- and middle-income countries. Management says total manufacturing capacity stood at 2 billion doses.

As of the end of August, the vaccine was in U.S. Phase III trials, across adults of all age groups. U.S. trial centers are recruiting up to 30,000 adults aged 18 years or over from diverse racial, ethnic and geographic groups who are healthy or have stable underlying medical conditions, including those living with HIV, and who are at increased risk of infection from the SARS-CoV-2 virus. The trial is assessing efficacy and safety of the vaccine in all participants, and local and systemic reactions and immune responses will be assessed in 3,000 participants.

AstraZeneca stated that clinical development of AZD1222 is progressing globally with late-stage clinical trials under way in the UK, Brazil, South Africa, India and Japan with trials planned to start in Russia. These trials, together with the U.S. Phase III program, will enroll up to 50,000 participants globally. Results from the late-stage trials are expected during 2020.

The company ran into some trouble in the progress of the vaccine in September. On September 9, AstraZeneca issued a statement that said, “a standard review process has been triggered, leading to the voluntary pause of vaccination across all trials to allow an independent committee to review the safety data of a single event of an unexplained illness that occurred in the UK Phase III trial.”

According to news reports, the trial participant was a woman in the United Kingdom who experienced neurological symptoms consistent with a rare but serious spinal inflammatory disorder called transverse myelitis. Soriot disclosed the details in a private call with investors, reports said. The woman recovered and was discharged from the hospital a few days after the hold was announced.

By September 12, clinical trials had resumed in the United Kingdom, following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so. As of October 2, the clinical trials had also resumed in Japan, Brazil, South Africa and India while discussions with U.S. authorities continued. 

In March, Pfizer engaged with BioNTech on a potential mRNA coronavirus vaccine. Pfizer promised to share tools and assets; marshal its people; apply drug-development expertise; offer manufacturing capability; and improve future rapid response. 

The German phase of the COVID-19 vaccine trial with BioNTech began in April. By May, the U.S. phase of the trial started, with the first patients being dosed. By July, the two companies had announced early positive data from a Phase I/II trial for BNT162b1, an MRNA-based vaccine candidate. FDA granted Fast Track Designation to BNT162b1 and the candidate was advanced into global clinical studies in July. Pfizer and BioNTech also pledged to provide 20 million doses of the vaccine to the United Kingdom, 120 million to Japan, 200 million to the EU, and 600 million to the United States.

In September, Pfizer and BioNTech proposed an expansion of their Phase III pivotal COVID-19 vaccine trial to up to 44,000 participants, which also allows for the enrollment of new populations.

The proposed expansion would allow the companies to further increase trial population diversity, and include adolescents as young as 16 years of age and people with chronic, stable HIV (human immunodeficiency viruses), hepatitis C, or hepatitis B infection, as well as provide additional safety and efficacy data. 

Based on infection rates, at the time, the companies expected that a conclusive readout on efficacy was likely by the end of October 2020.

In August, Pfizer announced a multi-year agreement to manufacture and supply Gilead’s investigational antiviral remdesivir as one of multiple external manufacturing organizations supporting efforts to scale up supply of the investigational treatment for COVID-19. Pfizer is providing contract manufacturing services at the company’s McPherson, Kansas, facility to manufacture and supply remdesivir for Gilead.

In February, Sanofi announced that the company would leverage previous development work for a vaccine against severe acute respiratory syndrome (SARS) to attempt to unlock a fast path forward for developing a COVID-19 vaccine. 

Sanofi and Translate Bio, a clinical-stage messenger RNA (mRNA) therapeutics company, during March announced a collaboration to develop a novel mRNA vaccine against COVID-19. This collaboration leverages an existing agreement from 2018 between the two companies to develop mRNA vaccines for infectious diseases. 

During April, Sanofi and GlaxoSmithKline announced that they had signed a letter of intent to develop an adjuvanted vaccine for COVID‑19, using innovative technology from both companies to help address the pandemic. Sanofi is contributing the company’s S‑protein COVID-19 antigen, which is based on recombinant DNA technology. GSK is contributing its pandemic adjuvant technology.

In September, Sanofi and GSK started the Phase I/II clinical trial for their adjuvanted COVID-19 vaccine. The Phase I/II study is a randomized, double-blind and placebo-controlled trial designed to evaluate the safety, reactogenicity (tolerability) and immunogenicity (immune response) of the COVID-19 vaccine candidate. A total of 440 healthy adults are being enrolled in the trial across 11 investigational sites in the United States.

The companies anticipate first results in early December 2020, which will support the initiation of a Phase III trial during that month. If data are sufficient for licensure application, the plan is to request regulatory approval in the first half of 2021. Sanofi and GSK were in advanced discussions in July with the EU to supply up to 300 million doses of the vaccine. They have agreed to supply 100 million doses to the United States as part of “Operation Warp Speed.”

At the end of September, CEOs from 16 life-science companies – AstraZeneca; BayerbioMérieuxBoehringer IngelheimBristol Myers SquibbEisaiEli Lilly; Gilead; GSK; Johnson & Johnson; Merck (known as MSD outside the United States and Canada); Merck KGaA of Darmstadt, Germany; Novartis; Pfizer; Roche; and Sanofi – and Bill and Melinda Gates, co-chairs of the Bill & Melinda Gates Foundation, signed a landmark Communiqué on Expanded Global Access commitment to ensure that people everywhere have access to the potential COVID-19 innovations under development at the companies, regardless of their income level. The agreement calls on governments, NGOs and other stakeholders to join the cause and help accelerate the end of the pandemic.

Johnson & Johnson, which is developing a COVID-19 vaccine with Moderna, plans to allocate up to 500 million vaccine doses to lower-income countries with delivery beginning mid-2021.

Johnson & Johnson’s lead SARS-CoV-2 investigational vaccine candidate is JNJ-78436735, also known as Ad26.COV2.S, which is being developed by Janssen Pharmaceutical Companies. During September, the first participants were dosed in the Phase 3 study ENSEMBLE evaluating the safety and efficacy of Janssen’s COVID-19 vaccine candidate. ENSEMBLE will enroll up to 60,000 volunteers across three continents and will assess the safety and efficacy of a single vaccine dose versus placebo in preventing COVID-19.

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