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Summary
- The US Centers for Disease Control and Prevention has issued notices to the states, urging them to be ready for a potential COVID-19 vaccine as early as November.
- Reportedly, Pfizer is all set to roll out its COVID vaccine before the presidential elections.
- The vaccination rollout timing has raised questions related to the effectiveness and safety of the vaccine.
History will never forget the unprecedented COVID-19 pandemic, a shock to society, health systems, governments, and economies, globally. Ever since its onset, leaders are making decisions to manage its impact and consequences.
Given the pandemic challenges, number of businesses have shut their operations, while few sectors such as tourism, travel, hospitality and aviation are struggling to remain relevant in the age of social distancing and figuring out how to adapt to these new challenges.
That said, when the world is waiting for a medical breakthrough in the form of an effective vaccine, here comes the news. The US Centers for Disease Control and Prevention (CDC), the nation's health protection agency, has urged state authorities to be ready for a potential COVID-19 vaccine, two days before the Presidential election. The CDC has issued notices to the states in this regard, urging them to plan for the vaccine distribution as early as 1 November 2020.
Must Read: How is the US Election Race Faring? Does it impact your portfolio?
Pfizer to Fast-Track the Vaccine Rollout
There are speculations that US-based drug company, Pfizer Inc. is all set to roll out its COVID vaccine before the US Presidential election. The Company has established that by end-October, it would know whether its COVID-19 vaccination is a success. If successful, the Company will quickly submit it for approval.
Pfizer is developing the vaccine with German partner, Germany's BioNTech. The company is set to conduct a live video webcast of its virtual Investor Day over two days on 14 and 15 September 2020, providing updates on its progress regarding R&D pipeline and product candidates.
The Vaccine Timing Raised Many Eyebrows
Experts are raising their concerns over the timing of the vaccination. Several pertaining questions are arising - what if the company has fast-tracked the process due to pressure from President Donald Trump's administration? Is the company risking people's health by compromising with the standard procedures for ensuring effectiveness and safety of the vaccine?
The other company in the vaccine race with Pfizer is Moderna. Both these companies started final third phase trials during late-July 2020, using the same technology based on messenger RNA. Until now, a technology focused on messenger RNA has not been proven in any vaccine. Pfizer's vaccine needs two doses within 21 days, whereas Moderna's vaccine requires double dose in 28 days.
Another prominent candidate for COVID-19 is being developed by the Oxford University and AstraZeneca, which is undergoing third phase testing in various countries.
Good Read: COVID 19 Vaccine Game Who will Pull Off?
Vaccination testing data will be reviewed by the Food and Drug Administration (FDA), which has hinted that a vaccine might be given emergency permission before the end of trial procedures. However, the FDA is receiving massive criticism from the medical fraternity for this hurry, as the pandemic situation is a health emergency, a too serious condition to mix with the politics.
For a detailed understanding on Clinical Trails, read here.
Pfizer, BioNTech Share Promising Early Data on Lead mRNA COVID-19 Vaccine
On 20 August 2020, the partners shared additional data on their vaccine candidate BNT162b2 being developed for COVID-19.
As per Pfizer, in its 1st phase study in the US, when the second dose of 30μg, BNT162b2 elicited SARS-CoV-2–neutralizing geometric mean titers (GMTs) was administered to young and older adults, after seven days, it demonstrated strong immunogenicity in these participants.
Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development, Pfizer, stated that this early data highlights the promising safety and immunogenicity profile of the vaccine candidate from the study conducted in the United States. In the near term, the company sought to sharing T cell immune response data from the trial being undertaken in Germany.
Among the volunteers for the vaccine, BNT162b2 was found to be well-tolerated with 20 per cent of them developing mild to moderate fever. The outcomes pushed the vaccination for 2/3 phase global study, which started in July 2020 and aimed to enrol a maximum of 30,000 participants between 18 and 85 years of age.
As per the partners, they are on track to seek regulatory review for the vaccine candidate by October 2020. If everything goes as per the plan, Pfizer will supply up to 100 million doses, globally, by the end of the year 2020. Moreover, the company expects to deliver nearly 1.3 billion doses by the end of 2021.
A Glance at Pfizer's Q2 Report
In the second quarter, the company reported:
- Revenues of USD 11.8 billion, representing a decline of 9 per cent. Furthermore, it reported 6 per cent operational growth from biopharma, primarily driven by Ibrance, Inlyta and Xtandi, Vyndaqel/Vyndamax, Eliquis. Thirty-one per cent operational decline from Upjohn due to the loss of exclusivity of Lycra in 2019. It was somehow balanced by 17 per cent Operational Growth in China.
- Reported Diluted EPS of USD 0.61 for Q2
- During the first half-year of 2020, the company paid USD 4.2 billion of dividends, including dividends of USD 0.38 per share of common stock in Q1 and Q2, respectively.
The company raised midpoint of 2020 financial guidance for revenues by USD 0.1 billion to USD 48.6-50.6 billion and for adjusted diluted EPS by USD 0.03 to USD 2.85-2.95.
Dr Albert Bourla, Chairman and Chief Executive Officer at Pfizer, highlighted that the company remains fully committed to developing a treatment for health challenges posed by the COVID-19 pandemic. Pfizer's robust performance during challenging times shows business resilience, he added.
