The Vaccine Page -- December 6, 2022

Some of these links are quite dated, going back to 2021.

First, pneumococcal.

Wow, talk about a lot of confusion with regard to which pneumococcal vaccine one should get. This confusion is generated by the relatively "quick" advances in new pneumococcal vaccines.

Many folks have already received an "older" pneumococcal but are now learning that "newer" pneumococcal vaccines with better coverage are now available.

This is what I understand, though I could be wrong. Many seniors have already had the "13 -strain" (PCV13) OR the "23-strain" (PPSV23) which were the recommended pneumococcal vaccines as recently as January 28, 2022. 

On October 21, 2021, the advisory committee recommended the "15-strain" (PCV 15) or the"20-strain (PCV20) for adults who had no history of pneumococcal vaccination. If one received the PCV 15 vaccine, it should be followed by the PPSV 23 one year later. 

On January 28, 2022, recommendations were simplified: either PCV15 in series with PPSV23 OR PCV 20 alone. 

Another way to write that: 

Adults aged ≥65 years who have not previously received PCV or whose previous vaccination history is unknown should receive 1 dose of PCV (either PCV20 or PCV15). When PCV15 is used, it should be followed by a dose of PPSV23. 

It makes sense to me to simply get the PCV20 and be done with it.

Recommendations vary for age groups and risk factors: the above seems to fit seniors with no risk factors.

Source: link here.

Break, break.

June 9, 2021: note the date. From FiercePharma this is interesting for investors interested in Pfizer and Merck. It provides some background for the pneumococcal vaccine for children. At that time, June 9, 2021, it appeared Merck might get its next-gen shot on the market for kids a year before Pfizer. Children make up roughly 80% of the market for pneumococcal shots. 

For pediatricians and mothers a pneumococcal vaccine for children is really, really important -- preventing meningitis at worse, but preventing a lot of pesky ear infections. The first pneumococcal vaccine was licensed for use in the US in 1977. That vaccine has been "improved" multiple times over the years and recommended for larger populations based on age.

I don't know how that race between Pfizer and Merck for the next-gen vaccine for kids turned out.

From the June, 2021, article, regarding the pneumococcal vaccine :

With Tuesday’s FDA nod for its next-gen pneumococcal vaccine Prevnar 20, Pfizer scored its second major vaccine win in seven months as it crossed the finish line ahead of rival Merck.

The shot, which attacks 20 different strains of the bacterium, is approved for adults 18 and over. It was fast-tracked for approval in December when the FDA not only accepted Pfizer’s application but set it up for priority review.

Meanwhile, Merck is hammering away at approval for its own next-gen pneumococcal conjugate vaccine, V114, a 15-strain shot. The vaccine scored priority review in January and its action date comes next month. Plus, because of its early study in youngsters, it could follow up with an approval in children a year ahead of Pfizer's.

Tuesday’s approval strengthens Pfizer’s hold on the pneumococcal vaccine market. Its Prevnar 13 generated sales of $5.95 billion last year, continuing its run as the world’s top-selling vaccine, at least until 2021's COVID revenues are tallied.

Prevnar 13 scored FDA approval in 2010, and in 2014 it won the CDC's backing in adults over 65.

That CDC decision fueled a blockbuster sales increase during the subsequent years. Prevnar 20 will tackle the same 13 serotypes included in Prevnar 13, plus seven serotypes associated with high fatality rates, antibiotic resistance and meningitis, the drugmaker says.

Break, break.

To get an idea how big this "industry" is, take a look at the FiercePharma article from November 23, 2021, link here. This is the story of the Covid-19 vaccine and treatment for the disease.

The COVID-19 pandemic is creating a $100 billion pharma goliath.

Pfizer’s revenue could reach $101.3 billion in 2022, with major contributions coming from the company’s BioNTech-partnered COVID vaccine and an antiviral therapeutic that has shown stellar clinical data, SVB Leerink analyst Geoffrey Porges projected in a Monday note to clients.

That level of revenue would be unheard of in the pharma industry. Johnson & Johnson, the world’s largest biopharma company by revenue for years, recorded $82.6 billion revenue in 2020. Pfizer’s own revenue in 2018 clocked in at $53.7 billion before the separation of its consumer health franchise into a joint venture with GlaxoSmithKline in 2019.

Of the $101.3 billion, oral COVID drug Paxlovid could contribute $24.2 billion and COVID vaccine Comirnaty $29.7 billion, Porges figured.

Paxlovid, when given to nonhospitalized patients within three days of symptom onset, cut the risk of COVID-related hospitalization or death by 89% compared with placebo in a late-stage trial, Pfizer said earlier this month. The drug is used in combination with HIV drug ritonavir.

Armed with the positive data, the New York pharma is seeking an FDA emergency use authorization for the drug. The U.S. government has bought 10 million courses for $5.29 billion.

Upper- to middle-income countries will be the main contributors to Pfizer's COVID drug revenue. The company has signed a licensing agreement with the Medicines Patent Pool, allowing 95 low- and middle-income countries to make their own versions of Paxlovid. In key target geographies for Pfizer, Porges expects governments will want to procure enough stockpile to cover 10% to 20% of their populations, a demand that he expects will unlikely be met in 2022 or 2023 because of capacity limitations.

Pfizer’s estimated 2022 production volume for Paxlovid is 50 million courses, while the entire stockpile demand is about 222 million courses, Porges noted.