Archive | November 2020

” Race for the Vaccine is on – Moderna, the Second to make an Announcement ” – November 16, 2020.

If your vaccine is 90% effective, our vaccine is 94.5% effective, says Moderna with a challenging look and statement , just a week after Pfizer announced its Vaccine ;

If your vaccine needs -70°C freezers for storage, our vaccine needs just -20°C (normal frigerators) to keep the vaccines safe for upto 30 days , says Moderna ;

If your vaccine had 44000 individuals for experimentation, our vaccine will do with full representative sampling consisting of just 30000 individuals now and more soon, says Moderna.

The announcement sets the bar high for standards of safety and efficacy, and medical interventions.

More than 94.5% efficacy ; more individual participation ; more number of individuals developing antibodies successfully without side effects ; general feeling of trust, passion, and confidence among individuals participating in the trials – will need to be highlighted by the pharma companies engaged in 3rd phase or otherwise of clinical trials now.

First mover advantage has shifted to Moderna from Pfizer at this juncture. Will Astra Zeneca, Johnson and Johnson, Novaxin, Bharat Biotech and others can surpass the safety and efficacy data already achieved by Moderna and Pfizer with better accuracy will be eagerly watched.

Mid/late December is the critical period in the US when the Political and Pandemic moment of decision will shape their end(s) of journey(s), the moment people will be waiting for. This will also mark the time when trends of the competing pharma companies will get their preliminary results of ‘who each one is ?’ ; ‘how each one will progress ?’ ; and ‘what authority can each leverage in implementing the process ?’.

Here’s a risk. If people will be revelling in joy during the Thanksgiving and Christmas holidays outside, COVID-19 will not lag behind to revel in disrelishing them instantly.

Vaccine race continues now. Smaller companies are in training for the big race against Moderna and Pfizer.

” Dieu avec nous”

Tuesday, November 17, 2020 – 12.19 p.m. (IST).

Tidbit : ” Another Vaccine just announced. This time by Moderna, 95% effective. For those great ‘historians’, please remember that these great discoveries which will end the China Plague, all took place under my watch”. – President Donald Trump.

” Auf Wiedersehen to COVID-19 – Pfizer’s First Move to Begin Competitive Marketing ” – November 11, 2020.

If Corona’s stellar role steered the public conversation away from the accomplishments of President Donald Trump during his Election campaign and even earlier denying a second term for him, the Vaccine developed by Pfizer/BioNTech announced just 6 days after the Election Day can help steer Joe Biden’s team to victory in controlling the pandemic while reviving the Economy and International travel.

President, Donald Trump, in fact, handed this to the Democrats on a silver platter even if they did not expect it.

Dr Anthony Fauci, Infectious Disease Expert and Leader of the Coronavirus Task Force under Mike Pence/Donald Trump, calls the Pfizer breakthrough as “extraordinary”, “help is on the way”, ” it will be good even if it is 50% effective”, and ” the vaccine will be in use by the end of the year “, while he was pitching into those who promised a cure for COVID-19 by late November or early December citing efficacy and safety as not achievable within weeks. Encouraging words now, nevertheless, for those holding faith and belief in Science, Data, Experiments, and Trials .

Pfizer promises 50 million doses by the end of this year, and about 1.3 billion doses by 2021. There will, however, be a huge sense of relief for people all over the world now.

Pfizer says : ” Submission for Emergency Use Authorization (EUA) to the Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved which is currently expected to occur in the third week of November “. Pfizer has spent nearly $ 2 billion of its own for research and development without any Government funding or under the Operation Warp Speed Program.

Pfizer vaccine is a two shot one ; there has been no papers in Journals or reviews by peer researchers ; there is however a safety monitoring authority checking their progress and events. The vaccine is based on ‘mRNA’ technology by injecting a catalyst that can form spike proteins on human cells with ability to detect the virus and destroy it. The only other company following this route of attack is “Moderna” which has received $ 1 billion in funding from the US Government. Other prominent players in the race include Johnson and Johnson ; Astra Zeneca/Oxford Institute ; Nova-Vax ; Sanofi ; GlaxoSmithKline and other small players numbering about 40 candidates in all.

There are billions of individuals in the world requiring vaccination, US alone has 300 million and more.

Two factors need consideration from the management/marketing perspective : (1) Competition ; and (2) Pricing.

1. Competition : Vaccine production and use has reached a stage of marketing warfare now. Emergency Use Authorization to Pfizer will immediately spur others in the race to make claims for their share, fame, and name. FDA will be highly vigilant and stringent in verifying the claims ; supporting evidences ; trial successes ; and absence of side effects. I may be wrong, ‘ that there has not been a success more than 60% (and it is for flu shot) in any vaccine case earlier in history’. This fact may have prompted Dr Anthony Fauci to expect at least 50% success/efficacy for use. Also, the world needs billions of doses that cannot be satisfactorily produced, stored, and delivered by a single Company. Hence, the ventures of 40 or more candidates make the effort justifiable.

Pfizer/BioNTech vaccine is ‘mRNA’ based ; two shot vaccine ; the second shot administered 3 weeks after the first ; vaccine needs to be stored at -75°C for which freezers are not ready yet ; Pfizer itself is testing storage with dry ice for the benefit of people ; has an excellent record of global supply chain and logistics for delivery. Its deal is valued at $ 39 for a two shot course. Moderna is in the same category. Its deal is valued at $37 per dose. J and J’s deal indicates a price of $10 per dose. It is a one shot vaccine. It has to be administered intravenously. It doesn’t require storage at such freezing levels.

Eli Lilly had already obtained Emergency Use Authorization for its monoclonal antibody treatment from FDA (just yesterday). It is a therapeutic and not a vaccine. There are many in the pipeline from different companies in different places.

Hence, the factor of Competition playing a role in the ‘ marketing opportunity’ of all the vaccines and companies is real. Safety and Efficacy are the set parameters determining the ‘Competitive Value or Strength’ of the vaccine.

Pfizer’s statement that it is 90% effective is a reassurance that one cannot ignore even if it remains to be fully validated yet. Pfizer’s financial strength, staff and scientists strength, and know-how relating a to vaccines and other drugs makes it a big game player. BioNTech of Germany being a partner adds to the clout it can reap in Europe. Other companies mentioned above also have similar strengths and competitiveness.

If a 50% efficacy is set as the main requirement (as Dr Anthony Fauci has referenced in his Observations), then the number of companies achieving the target is expected to be in good numbers. To be in the race for a preferred vaccine manufacturer, distributor, and courier (delivery agent), the companies may resort to ‘Competitive Reactions’ in terms of price adjustments. More the competition, more will be the price cuts or discounts whether during the pandemic period or later. It will be important for the companies to note the fact that the demand for vaccine may be steady initially (as it is a public health issue requiring everyone to be vaccinated) but likely to become volatile later when it will become a choice.

The companies may also offer different prices for different regions depending on their perceptions of values in terms of fame, reputation, and service. There could be some innovations here.

2. Pricing : Pricing is critical in a Global Health Issue like this involving people of different nations ( developed, less developed, marginally efficient, poor ) with people of different financial abilities. Pfizer’s $ 39 for two doses ; Moderna’s $ 37 for two doses when compared with Astra Zeneca’s $ 3 per dose or Johnson and Johnson’s $ 10 for the only shot required are too high for any ordinary individual without a subsidy from the Government.

Companies engage in ‘pricing’ with the following considerations : Raw materials/basic ingredients for vaccine production ; research scientists’ term pay ; clinical trials ; and labour costs in production constitute the variable costs. Cost of equipment/tools ; laboratory infrastructure ; and other administrative costs constitute the fixed costs of vaccine production. Margin to meet the profit objective will be added to arrive at the selling price of the vaccine per unit.

Astra Zeneca/Oxford University has pledged not to profit off the COVID-19 shot during the pandemic. Its pricing indicates cost of manufacturing plus $ 1 billion for clinical trials ( or a 20 % of the cost of manufacturing to the vaccine’s price ). It has established Quality Assurance already. Deals for 100 million doses to UK ; 300 million doses to U.S.A., 400 million doses to EU ; 120 million doses to Japan ; and 100 million doses to China are promised already. It has also built a Global Supply Chain with ability to turn out 3 billion doses of vaccine. Astra Zeneca’s price per dose is just $ 3 to $ 5. It has also promised that low income countries will receive its vaccine on a cost basis ” in perpetuity “. It has a headstart in the marketing warfare already.

Administration of a vaccine is a Public Health Measure in which every individual – male/female ; young/old ; symptomatic/asymptomatic ; whites/blacks – participates. It is also the duty of any Government to contain the pandemic as a welfare measure. Individuals, every human being in the world, may not be willing to pay the same price for vaccination. These aspects make price setting a challenge while prompting companies to think in future in terms of alternate price levels. Moderna has declared that in the pandemic period, pricing considerations will follow traditional dynamics and market forces including vaccine efficacy and Competitive landscape.

It appears that the very emergency nature of the Disease may help the companies make hay as the sun shines ; and the pricing war will likely begin only after the emergency measures are relaxed. This is also quite in tune with what any Product Life Cycle teaches us during the period of growth when prices remain high and affordable for the top and special categories of people. Pfizer and Moderna may rule the roost initially (catering to the prioritised groups supported by concerned institutions and the Government in specially the well developed nations) while the likes of Johnson and Johnson, Astra Zeneca and others in the same pack will eke out their share in a different way in different countries with different population groups.

A clear picture will emerge only after the companies report their safety and efficacy data in public.

“Dieu avec nous “

Wednesday, November 11, 2020 – 2.19 p.m. (IST)

Tidbit : ” It is a great day for science and humanity “.

” Joe Biden is Third Time Lucky as Republicans Prepare to Take Their ‘ lumps ” – November 7, 2020.

Joe Biden is now the American President-elect ; Kamala Harris is now the American Vice President- elect. (Saturday, November 7, 2020).

Third time lucky ; oldest to occupy the prestigious President-elect post ; highest number of votes secured by any Presidential contestant in the history of American Elections.

Joe Biden who championed the cause of health and safety won. Donald Trump who took the initiative to champion the cause of opening the Economy lost. Is this a victory for Health and Safety over reopening of the Economy will be the matter of debate from now.

What was achievable, believable, and expected had always been on the Election Horizon since the pandemic struck America forcing the attempts to embrace health and safety as the priority of Citizens.

It is also testimony to the changing intellect of voters and the novelty of their decision making amidst the pandemic struggle that brought smiles in the faces of not just the challenger (Joe Biden and his team) but also among a large section of people in this world.

The reasons for this are twofold :

1. Misjudgment of the Republicans : Strong misjudgment about the challenger (weak, frail, old, short of mental acuity, low energy) coupled with strong misjudgment of the situation. From the day of his inauguration on January 20, 2017, President Donald Trump was on fire with enthusiasm, passion, and obsessive zealousness to change the course of direction that Washington DC had taken in serving the people. This effectively drove him to adopt an unconventional strategy which centered on his deep conviction to change the order of plans, policies, programs, treaties, agreements in favour of only America and Americans. It was just a coincidence that many of those decisions came to represent a revenge on his political enemies. Ill-will was borne, nevertheless. It may be correct and proper to say that his “goal” or “mission” was right but the “path” or “means” taken with the accompanying rhetoric invoked anger and fear among the opponents spreading discontent and disapproval. And the fact that the perceptions and beliefs of Citizens while casting their votes were an expression of their positive and true assessment has been validated in the results. It favoured Joe Biden and dismissed Donald Trump.

2. Aggressive Campaigning in the last two weeks : President Donald Trump, himself suffering from COVID-19 ; getting admitted to Walter Reed Hospital for treatment ; coming out of the hospital in 2 days and resuming his task of campaigning through in-person rallies (with 3 to 5 rallies a day) ; drawing huge crowds against the Public Health dictum – all instead of amplifying the support for him seems to have amplified the force of opposition to Trump. But what was too little too late as the election results would show was enough to get the margins narrow, but not enough to surpass Biden’s challenge. Pandemic and Healthcare generally regarded as the defining factors for the voters’ choice in casting their votes prevailed. Alternately, Economy and Law and Order – greatly expected to play a significant role – which was less talked about, discussed, or emphasized by the media, analysts, and even people in the run up to this election have not lived upto their expectations. It effectively got submerged in the persistent and insistent din of health and safety. Minds of voters were more stimulated by the novel issue of the mismanagement of the pandemic, a rare election where an issue of this nature taking centre stage.

General Commonsense Observations : News of President Donald Trump’s early leads in many States must have come as a shock to many pollsters, analysts, party media, and to the Democratic Party Team. That Joe Biden will win in a landslide and Donald Trump will be facing a humiliating defeat did not hold true. In effect, it was a contest between a Team strongly backed by big money, big tech, and big media with deep interests and a person with Personal Charisma. Unlike the polls of 40 or 50 years earlier, voters have not enthusiastically responded to the telephone calls or avoided reflecting their true preferences to the pollsters specially since June when most polls predicted Biden’s victory. Remaining optimistic and responding to the challenge, the Republican voters, specially, were happy to abide by the President’s call to turn out in large numbers for voting on the Election Day. Florida, Texas, Ohio, and Iowa … remained solidly behind Donald Trump. Dark clouds of defeat seemed to have its silver lining in the determination of his voters (his base) including Latinos and some blacks in the voting process ensuing a smooth running of this historic Election.

If Joe Biden stands as the only Presidential candidate with the most number of votes polled in an election in the American History ; Donald Trump has also the distinction of being the second highest in terms of votes scored. That this has happened in this unique election is more than special.

For every success, a ‘dream’ is an important requisite. To fructify the dream, ‘hard work’ is more important. Dream and Hard Work should run in a parallel manner without letting it slip. Hard Work without Careful Thought and Dream without Hard Work cannot result in sprouting fields even if the seeds are sown in time. Biden’s Teamwork may well be an exemplification of this measure.

God “Bishamonten”, (God of dignity and authority) protector of those who follow rules and behave appropriately, surprised everyone with a life changing moment for the Citizens of America in this Election. Will it change the lives of Citizens for better for years into the future is what everyone will be eager to see and experience.

” Dieu avec nous “

Sunday, November 8, 2020 – 7.25 a.m. (IST)

Tidbit : ” This is the time to heal in America. I owe you everything ” – Joe Biden in his address.

” US General Election, November 3 – The Die is Cast ” – November 2, 2020.

US General Election will be held on November 3, 2020.

President Donald Trump’s team seems cautiously optimistic.

Joe Biden’s team seems invincible.

Who gains or who loses is not known now, but nobody will be in doubt.

But a day or two before the election, as now, President Donald Trump’s chances will depend on the following three factors as depicted in the figure below :

Let us consider the three factors : Visibility, Performance, and Leadership.

1. Visibility : A true leader is one who has a large segment of population in terms of age, gender, and social class as dedicated followers. They will want to see the leader’s face, posture, and expressions in realtime in public. What the leader speaks and promises will influence them to think, feel, and make their choice better. President Donald Trump’s visibility, specially, during the last few days in social space is high. In one day, the day before, he had five rallies, each with huge crowds in thousands. In Michigan, he said : ” Two days from now, we are going to win the State of Michigan again “. In Georgia, he said : ” Next year we will see the greatest economic growth in the history of America “. In Florida, he asked : ” Is there any place you would like to be rather than in a Trump rally ?” Everyone will be expecting a new surge in voting.

President Donald Trump has raised his visibility. Whether this will change the minds of voters in his favour is still uncertain.

2. Performance : He has kept the promises he made in 2016 to the people. He mentioned them in his speech in North Carolina yesterday and reiterated moving further on these : ” We are going to cut taxes ; cut regulations ; support police ; defend religious groups and their liberty ; produce more of what you produce now and make it ‘Made in America’ “. He handled the lootings, violent protests, and riots in Kenosha, Minnesota, and Portland with decisiveness even if it fell short of a healing process totally.

President, Donald Trump, is basically a businessman and not a politician. His chief armour in his weaponry for getting people on his side has been his PR (Public Relations) and Sales Pitch striking an unusual but welcome tone not seen generally among politicians and which people found attractive. This made people feel he is genuine. Will they hold the same opinion now is not certain.

His strength (weakness really) also constituted his blunt and candid expressions (good and not so good) about other leaders, opponents, aides, and individuals. His handling of COVID-19 has come in for sharp criticisms and condemnation for his refusal to listen to the advice of Scientists, Doctors, Experts, and Public Health Specialists. His gamble to concentrate more on Economy over Public Health and Safety may have separated him from not just his associates but the general public at large at this critical juncture.

A final word on this (how he scores on this characteristic) will be afforded by the people in the result of the Election.

3. Leadership : ” President Donald Trump is a Leader with little respect for delegation. He is always focused in a way translating his principles and beliefs into actions. His actions will rarely give or point to a leader in control for the analysts, academics, and professionals in management. He is a ‘different’ leader. While some may be tempted to call his style of management in terms of being an authoritarian or even closer to being a dictator, the reality lies in the fact that he is one who would like to “create an identity” that is unique and think of himself as one who is not fit to hold a candle to any other. It is probably an inner desire driven by what many experts may term as ‘egoistic’. This is a factor that seriously clouds his trust among people and his re-election despite some good work on foreign policy, economy, military strength, immigration, and tax benefits.

Willingly or otherwise he has been disruptive and specially in this challenging moment of the pandemic holding firmly to his views without much embracing the general/expert opinions. Public suffered. Credit or blame to whatever happens to people in a term is generally fixed to the leader who held the fort.

Conclusion : The statistics in terms of Coronavirus impact seem aligned with his poll margins and prospects that make his second term a non-starter at this juncture. True, people will decide, but the die has been cast long before the voters enter the numbers on the ballot papers.

The “Curriculum Vitae” (CV) for this election can be written in two words : “Corona Virus” (CV).

” Dieu avec nous”

Monday, November 2, 2020 – 4.49 p.m. (IST)

Tidbit : ” It is Election uncertainty that will be in the lips of everyone “.