This comes as a result of Merck’s COVID-19 drug producing data showing if given at the onset of COVID-19 related illness, the probability of fatality by the virus is cut in half for individuals in the severe risk category of COVID-19 complications. Merck’s COVID-19 pill reduces the chance of hospitalization as well.

In fact, an industry expert stated that Merck’s COVID-19 pill, Molnupiravir, possesses the ability to successfully battle this pandemic, along with other drugs and vaccines which makes the battle against COVID-19 a collective effort. Merck’s COVID-19 drug joins the fight against the virus in this way.

President Biden revealed that his government had bought millions of courses of Merck antiviral pill rival, Pfizer, as well. Pfizer’s COVID-19 drug shows a reduction in hospitalization and fatality by 89% in the same risk group. Merck’s COVID-19 news further reveals that the U.S. government can place a purchase order for 2 million more courses of Merck’s COVID-19 drug. Currently, the number of treatment doses are over 3 million, which are valued at $2.2b.

A health official said that Merck and Pfizer’s deal negotiations have similar terms that consist of 1.7 million courses to be bought upfront and a possibility for 3.3 million additional courses to be bought at a later stage.

Merck’s COVID-19 news further discloses that for countries in the high income bracket, Molnupiravir’s treatment course will be sold at $700.

By the end of 2021, production of 10 million treatment courses of Merck’s COVID-19 pill is expected, with double this amount expected in the coming year.

Merck antiviral pill is manufactured by bothMerck & Co Inc and its partner Ridgeback Biotherapeutics.

“There is no generic of vaccines, for example. So it’s a different type of lifecycle, but it can be a very good business if you bring innovation,” stated CEO of Takeda Pharmaceutical Co., Christophe Weber.

The drug giant had a $59 billion megamerger with Shire after which it has put an added emphasis on its vaccine group. The availability of Moderna’s mRNA based COVID-19 vaccine in Japan is credited to this giant pharma.  

The rollout of vaccines recently had a hard hit as the distributed vials have shown traces of contaminants which the two companies have traced back to the production line at a contract manufacturer in Spain, resulting in revocation of 1.63 million doses, hence halting vaccination process.

Weber dismissed the suspicion that the contaminants resulted largely because of incautiousness due to the briskness in manufacturing COVID shots and said that such problems can occur during manufacturing processes.

However, the two companies have appeased that the contaminants aren’t expected to compromise the safety.   

Meanwhile, Takeda is also contributing largely in manufacturing, regulatory submission and marketing of Novavax’s COVID-19 vaccine, dubbed NVX-CoV2373, in Japan, which is an adjuvant protein-based COVID shot.

The Japanese government has planned to purchase 150 million doses of the said vaccine’s investigational shot lately. According to the company, the Japanese regulators’ approval is expected this year. 

Takeda’s interest in vaccine business predated current COVID programs. TAK-003 is company’s Dengue vaccine ready to be commercialized with EU regulatory decision anticipated in the coming year.

The said vaccine is expected to be introduced in populated Dengue-endemic countries in Southeast Asia and North America, and also United States, in 2022.

Sanofi’s Dengue vaccine, Dengvaxia, is largely renounced after the company found out that it could create higher chances of previously uninfected people to get severely affected upon being infected. Whereas, Takeda’s TAK-003 Dengue vaccine indicated no evidence of intensification of the disease in seronegative people along with the strong efficacy in reducing Dengue-related ailment.

The Japanese pharma giant is building production capacity to develop and manufacture approximately 50 million doses of TAK-003 in a year. As per the prediction, the peak sales of this vaccine can bring whopping $1.6 billion to the company.       

Apart from COVID and Dengue vaccines, the drugmaker is also working on Zika vaccine, dubbed TAK-426, expecting to launch it within next 4 to 5 years.

In the coming year, the supply of vaccine doses could trump its demand for the first time. Furthermore, by the start of next year, it is possible that there will be enough doses to jab every adult around the globe.

These projections are made through modeling by Airfinity, an information and analytics company based in London. Approximately 50% of these vaccine doses are to come from manufactures from China.

The association stressed, “strategically release doses so that vaccines leave the production lines and reach the people who need them most, from healthcare workers to vulnerable populations.” iterating that regardless of the likely large number of doses available, low and middle-income countries will have access to these doses only if high-income countries stop stockpiling the vaccine and allow access.

The reason for the above statement is that a significant number of vaccines in production are already booked. Examples of this include Pfizer which is expected to have produced 3 billion doses this year, but all of these doses have been booked. Pfizer’s Chairman and CEO, Albert Bourla further stated that Pfizer is expected to have produced 4 billion doses in the coming year, with most of them having been assigned already.

According to Airfinity estimations, the U.S., Canada, U.K., and the EU will possibly have 500 million vaccine doses that they could redistribute by September end. Their modeling report also found that even if the G-7 group of nations provide their own populations with booster shots, 1.2 billion doses will still be available for low and middle-income countries in the present year.

However, with only 3% of the Africa continent population having been fully vaccinated and the international COVAX initiative having supply chain problems, most people do not believe that this promise of vaccine distribution will materialize.

The founder and director of Health Justice in South Africa, Fatima Hassan expressed that Pharmaceutical Manufacturers greatly limit the manufacturing of their vaccines and this system has led to failures for the safety of the global economy. Thus, even with the expected quantity of doses becoming available, they may not be equitably distributed among the global population. Further adding “Now we’ve been told to still wait; equity for us is something that might happen next year, what happens in the meantime? Must we all get sick and die? And have a wave four, a wave five, and a wave six?”

It is possible to vaccinate the global adult population by June, according to Airfinity’s projections.

Pharmaceutical Manufacturers debate that resources are spent wiser on manufacturing at their current capacities and with their picked partners, while there is pressure on these companies to switch to a wider base of manufacturers globally, and provide them with the necessary technological training for production.

When companies have expanded their manufacturing, it has not always worked out for the better.  Johnson & Johnson has such a contract with South African Aspen Pharmacare. This involves Aspen Pharmacare carrying out the “fill and finish” portion of manufacturing after the vaccine has been sent from Europe, to be first placed in bottles and then shipped from their plant. Johnson & Johnson faced heavy controversy after these bottled vaccines reached Europe and since then, the company has discontinued the arrangement, however, the contracts are not viewable for the public.

Vice-Chairman of the Executive committee and chief scientific officer at Johnson & Johnson, Paul Stoffels, further informed that the company is in the process of carrying out technology transfer to Indian Biological E, in order to enable it to produce the vaccine.

A third death has occurred in Japan following the administration of a dose of the Moderna vaccine from one of the recalled batches that were discovered to have pollutants. Authorities insist that no causal link between the man’s death and the dose has been found yet.

The man, who was 49 years old received his second dose of the vaccine on the 11th of August, passing away the next day.The health minister stated on Monday that the man only had one health issue, which was an allergy to buckwheat. The ministry stated that it was not yet confirmed that this tragedy was a direct result of the vaccine, as was stated for the prior two fatalities as well.

The dose originated from part of the three recalled batches on 26th August of the Moderna vaccine, numbering 1.63m. This was not from the batches that were discovered to contain pieces of stainless steel in them. The three recalled batches in question were contracted under Moderna and were produced in Spain.

Comments from the company: “This is a tragic event, and the loss of life is something that we take very seriously. We offer our sincerest condolences to their loved ones.”

Local distributor Takeda Pharmaceutical and Moderna presented a joint statement in the preceding week stating:  “The rare presence of stainless steel particles in the Moderna Covid-19 vaccine does not pose an undue risk to patient safety and it does not adversely affect the benefit/risk profile of the product.”

In the previous month, two individuals who had no known health conditions, passed away after receiving the second shot of the same vaccine.

In Gunma, Okinawa, and Kanagawa pollutants identified as particles of rubber were found to have entered the vaccine fluid as a result of improperly inserted needles. No issues were conveyed by individuals who were administered the contaminated vaccines that originated from other batches apart from the recalled batches.

The minister who is in charge of the vaccine drive, Taro Kono reported that over 500,000 individuals have been administered doses from the three contaminated batches.

59% of the Japanese population has received at least one shot of vaccine, while 48% are fully vaccinated, bringing the total of administered Covid-19 vaccine doses to approximately 136 million. The larger proportion of vaccines that were used in Japan were manufactured by Pfizer, however, close to 18 million Moderna doses had also been given until 26th August.

In Tokyo newly reported infections fell below 1,000, which had not happened since mid-July, as reported on Monday.

According to the drugmaker, Roche Actemra IV’s demand ramped up during the recent COVID-19 wave caused by the highly contagious delta variant of the virus. Considering only the last two weeks, the demand for the drug took flight to reach up to 400% as compared to the pre-COVID days, and is still increasing.

The U.S. Food and Drug Administration, in June, issued an emergency use authorization (EUA) of Actemra IV only for the treatment of COVID patients. Unfortunately, the 200 mg and 400 mg dose formulations of the drug are already out of stock in the United States for the time being, and now it is running out of the 80 mg dose supply as well, said the biotech.

However, Roche Actemra injectable form that is solely used as a therapy for arthritis and other inflammatory-related conditions, are still available in the market, it further added.

The end of this month awaits further shipments of the drug. Roche Actemra subsidiary, Genentech, stated, “However, if the pandemic continues to spread at its current pace, we anticipate additional periods of stockout in the weeks and months ahead.”

The FDA said that the infused form of the drug is being used as a therapy for COVID-stricken people who are receiving systemic corticosteroids and need supplemental oxygen, extracorporeal membrane oxygenation or mechanical ventilation. Hence, it is only authorized for the hospitalized patients and not the outpatients.  

The company, in May, had filed a new drug submission (NDS) to the agency. The screening phase of the drug has been completed and application has been approved for rolling review, according to the company.

The rolling submission has allowed the company to submit safety and efficacy data in a continuous manner as soon as it becomes available, accelerating the overall reviewing process by the agency.   

Jovan Antunovic, Celltrion Healthcare Canada commercial director, stated, “We are pleased the new drug submission has been screened and accepted for review by Health Canada and anticipate this accelerated review process will enable people in Canada to have access to safe and effective treatment against Covid-19 as early as possible.”

He further added, “The initiation of a rolling submission for Regdanvimab (CT-P59) in Canada is a significant milestone and we remain committed to closely working with the Canadian regulatory authorities.”

The data obtained from the pre-clinical trials has indicated that the antibody has the potential to neutralize the SARS-CoV-2 virus by attaching to its receptor-binding domain (RBD).

Global phase III trials of the drug have mitigated the risks of hospitalization, oxygen treatment and death due to COVID-19, by 72%, in patients having high vulnerability to the disease.

On the whole, for all treated patients, 70% risk has been reduced through the drug in contrast to the placebo.

Besides, the drug has offered a minimum of 4.7 days decrease in clinical recovery time in patients with higher risks of disease progression; and for overall patient population, it has offered a 4.9 days decrease, comparing with placebo.

By March, Regdanvimab managed to get recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), to be used as a treatment for patients with high progression risks of COVID-19.

Currently, Celltrion is working on developing an antibody cocktail with Regdanvimab, to neutralize several emergent variants of SARS-CoV-2.

The strategy would be applicable to all vaccinated people. However, the official said that the decision for the people with weak immune system is likely to be taken shortly.

The booster shot for COVID-19 vaccinated people is yet not recommended in the United States. Nevertheless, if it is recommended, U.S. will have its supply, personnel and also the capacity to efficiently launch it, the officials said.

FDA is working out the solutions regarding uncertainties in the use of COVID-19 vaccine booster doses, together with NIH and CDC, FDA spokeswoman told CNN. 

The spokesperson, Abby Capobianco, said in a statement, “The agencies are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary.”

The decision to lay out a plan for booster shots is taken as the country continues to suffer with the surge in COVID cases and hospitalizations, due to the highly contagious Delta variant, largely among unvaccinated people. 

In getting eligible American population vaccinated against COVID-19, Biden administration has played a significant role. The percentage of fully vaccinated people, out of the ones eligible for vaccination, has reached up to 49.9% as of Thursday, 5^th of August, 2021.

According to the data provided by U.S. Centers for Disease Control and Prevention (CDC), the daily pace of vaccinations is the highest in past seven weeks.

Despite the World Health Organization’s call for moratorium on booster shots till end of September at least ̶  so that 10% of every country’s population gets vaccinated ̶  few countries including France, Germany, Israel and the U.K. are already proceeding with the plan to administer COVID-19 vaccine booster shots starting September or even before. 

People with compromised immune system may be needing supplementary protection even after receiving COVID-19 vaccine, said Dr. Anthony Fauci, the head of the National Institutes for Allergies and Infectious Diseases. A lot of effort has been put in making vaccine boosters available to such people “very soon”, he said.

Vaccine advisers to the CDC have held a discussion in this matter, however, they have neither given any formal recommendation regarding giving booster shots to immunocompromised ones, nor have voted for guidance yet.

“We are trying very hard to get the regulatory mechanism in place very soon to get those individuals a boost that might bring up their immunity to the level where it should be, if possible,” said Fauci.  

COVID-19 vaccine booster by Moderna showed 93% efficacy and resilience through six months against the disease, whereas, Pfizer/BioNTech demonstrated overall six-month efficacy of 91%. Nevertheless, the follow-up data collected for both the vaccines is not recorded after a surge is being noticed in cases due to Delta variant of the virus.  

In Moderna’s view, the Delta variant can bring more advanced infections, so the vaccine boosters will be needed before winters.

Pfizer is all set to submit its booster for the emergency use authorization (EUA) consideration by this month.

A number of people have been seen seeking treatments to reduce obesity during the pandemic. Novo Nordisk CEO said this while referring to the soaring sales of their recently launched weight-loss drug, Wegovy, causing a rise in their earnings forecast for the year.

“I think the (COVID-19) pandemic has underlined the importance of treating obesity more than ever,” Chief Executive Officer of Novo Nordisk CEO, Lars Fruergaard Jorgensen, stated. “There is a general sentiment building that it is a disease and it is a disease that takes medical intervention.”

It’s been only six months Wegovy was launched, however, the prescriptions for the drug have already made it to the level of other obesity drug, Sexanda, by the same drugmaker, which was launched in 2015.  

The said drug belongs to the GLP-1 analogues, a range of new diabetes and obesity drugs. It reduces appetite and increases feelings of fullness in patients, giving impression of a gut hormone which stimulates the production of insulin in the body.

“Of the 650 million living with obesity today only 2% are treated with prescription medicine so obviously it’s a huge opportunity,” said Jorgensen. Though he was with the view that it was precocious to predict about its future growth.

The Danish drug-maker amazed the market on Wednesday by posting its second-quarter earnings, surpassing its estimate, with shares closing up at 4.8% which continued to go up by 3% in early trade, the next day.

Eli Lilly and AstraZeneca, along with some other renowned pharma companies, are also included in the list of companies trying to hit the market with their obesity drugs.     

In terms of efficacy, REGEN-COV has proven to be more resilient against all coronavirus variants known so far. The company reported $2.59 billion sales of its COVID-19 antibody cocktail treatment on Thursday, making its apparent dominance over the market.

As a matter of fact, the company’s antibody sales, beyond doubt, took off to another height in the second quarter that it surpassed entire first-quarter’s revenue of $2.53 billion.  

The quarterly increase in REGEN-COV sales counterpoised Lilly’s antibody sales in a way that the latter reported decline in its bamlanivimab and etesevimab sales, from $810 million in the first quarter of 2021 to $149 million in the second.

The reason behind Regeneron antibody soaring sales isn’t confined to just efficacy or resilience of the drug against all variants, rather, the REGEN-COV also won FDA’s emergency use authorization to be administered at a lower dose by injection, about two months ago. Besides, the treatment has also gained another indication as a preventive measure for those who have contracted the virus.   

After a gradual start, the company is now witnessing an increasing trend in the sales as 50,000 courses are being ordered on weekly basis, CEO Len Schleifer stated. 

Planning to further expand the label, the Chief Scientific Officer, George Yancopoulos, said to the investors, “Still under review by the FDA are additional data which we believe could broaden the prevention application to pre-exposure prophylaxis, as well as to extend the treatment paradigm to hospitalized patients.”          

An agreement has been signed between Regeneron and United States for the provision of 1.25 million REGEN-COV doses during the second quarter. The drugmaker doesn’t expect additional sales to U.S. in third quarter. As far as fourth quarter sales are concerned, it will be dependent on the number of COVID-19 cases. Bernstein analyst, Ronny Gal, predicts an additional sale of REGEN-COV worth $1.2 billion for the rest of the year.