Merck Press Release (July 30, 2019) Announces Second-Quarter 2019 Financial Results

Vaccines

• Merck announced the U.S. Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) voted to recommend Human Papillomavirus (HPV) vaccination with GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) based on shared clinical decision making for individuals ages 27 through 45 who are not adequately vaccinated. The ACIP also voted to expand routine and catch-up recommendations for males through age 26 who are not adequately vaccinated.
• Merck presented Phase 2 trial results of V114, the company’s investigational 15-valent pneumococcal conjugate vaccine, which demonstrated noninferiority to PCV 13 for all shared serotypes and an immune response for two additional disease-causing serotypes, 22F and 33F in healthy infants. Results were presented at the European Society for Paediatric Infectious Diseases (ESPID). V114 is currently in Phase 3 development.
• Growth in vaccines reflects higher sales of GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] and GARDASIL 9, vaccines to prevent certain cancers and other diseases caused by HPV, primarily due to public sector buying patterns, demand and pricing in the United States, and the ongoing commercial launch in China. Higher demand in Europe, driven primarily by increased vaccination rates for both boys and girls, also contributed to sales growth.

• Growth in pediatric vaccines was driven by M-M-R II (Measles, Mumps and Rubella Virus Vaccine Live), a vaccine to help prevent measles, mumps and rubella; VARIVAX (Varicella Virus Vaccine Live), a vaccine to help prevent chickenpox; and PROQUAD (Measles, Mumps, Rubella and Varicella Virus Vaccine Live), a combination vaccine to help protect against measles, mumps, rubella and varicella; reflecting higher demand, including private-sector buy-in, and pricing in the United States; government tenders in Latin America and higher demand in Europe.

There appears to be a major disconnect between the scientific evidence about the safety and efficacy of the MMR vaccine and the HPV vaccine and the extraordinary high profit garnered by Merck from the sale of these two vaccines.

1. In 2018, the Centers for Disease Control acknowledged that:

“Overall, cervical cancer rates have fallen. Between 1999 to 2015, cervical cancer rates decreased by 1.6% a year, a continued trend since the 1950s as a result of cancer screenings.”

• The HPV vaccine was introduced in 2006, seven years AFTER cervical cancer had been decreasing steadily thanks to PAP screening. So, why is the HPV vaccine getting all the credit?

2. In 2012, the Mayo Clinic Vaccine Research Group headed by Gregory Poland, MD, the Editor-in-Chief of the journal Vaccine acknowledged that:

“concerns lurk, unnoticed for the most part. Despite the [sic]gains measles is reemerging as a serious public health threat, and outbreaks are occurring even in highly developed countries where vaccine access, public health infrastructure, and health literacy are not significant issues. This is unexpected and a worrisome harbinger – measles outbreaks are occurring where they are least expected… since 2005 these outbreaks have also occurred in the U.S.—with surprising numbers of cases occurring in persons who previously received one or even two documented doses of measles-containing vaccine. In fact, as of September 2011, the U.S. has had 15 measles outbreaks with 211 confirmed cases—the highest number of cases since 1996. Where data exist such outbreaks result from both failure to vaccinate, and vaccine failure.”
The Re-Emergence of Measles in Developed Countries: Time to Develop the Next-Generation Measles Vaccines

3. In 2015, Dr. Poland and the Mayo Clinic Research team acknowledged:

• “Despite the enormous population benefits of routine vaccination, vaccine adverse events (A-E) and reactions, whether real or perceived, have posed one of the greatest barriers to vaccine acceptance.

• Understanding and preventing serious adverse vaccine reactions is critical to improving public trust in vaccine safety and to developing new safe and effective vaccines.
• “Vaccine immunogenicity and vaccine adverse events have been reported at higher rates for females than males for multiple vaccines; This observation warrants further evaluation”.

See: Adversomics: A New Paradigm For Vaccine Safety And Design, Expert Review Vaccines. 2015 

Below is the CNBC report highlighting the Key Points

• Sales of children’s vaccines, which includes the New Jersey-based company’s MMR vaccine for measles, jumped 58% year over year to $675 million, Merck announces in its second-quarter earnings report.
• Merck says the strong growth is due in part to this year’s measles outbreak, which was the largest in the U.S. since 1992.

An additional key point: Merck has a virtual monopoly on both of these blockbuster profit-generating vaccines in the U.S.

In 2006, Merck launched the HPV vaccine, promoting a school-entry mandate. Its modus operandi was to lobby state legislators with bags of cash.

[See, Pharmaceutical Companies’ Role in State Vaccination Policymaking: The Case of Human Papillomavirus Vaccination, MM Mello, S Abiola, and J Colgrove, American Journal of Public Health ion, 2011]

Merck’s successful lobbying method for its vaccines has not changed in 2019.

Question:  How much $$$ did Merck contribute to the campaign chests of the New York State Legislators Who Voted — Without a Single Public Hearing – to Eliminate the Religious Exemption From the state’s mandatory Childhood Vaccination Schedule?

US Measles Outbreak Helps Boost Merck’s Vaccine Sales in In Second Quarter Berkeley Lovelace Jr.  CNBC News, @BerkeleyJr, Tue, Jul 30 2019 

Key Points

• Sales of children’s vaccines, which includes the New Jersey-based company’s MMR vaccine for measles, jumped 58% year over year to $675 million, Merck announces in its second-quarter earnings report.
• Merck says the strong growth is due in part to this year’s measles outbreak, which was the largest in the U.S. since 1992.

Pharmaceutical giant Merck said Tuesday that high consumer demand for its measles vaccines, amid the largest U.S. outbreak in decades, helped boost sales in its second quarter.

Sales of children’s vaccines, which includes the New Jersey-based company’s MMR vaccine, for measles, mumps and rubella, jumped 58% year over year to $675 million, Merck announced in its second-quarter earnings report Tuesday. Merck, which is the sole U.S. supplier of measles vaccines, said the strong growth was due in part to this year’s measles outbreak, which was the largest in the U.S. since 1992.

“There was some buying to the private sector within the U.S. this quarter based on some of the measles outbreaks that you read in the news,” Merck Chief Commercial Officer Frank Clyburn said in a post-earnings conference call with investors. “And we do believe that we’ll continue to see growth for our pediatric vaccines going forward.”

Shares of Merck were up more than 1% in midmorning trading after posting quarterly earnings and revenue that easily beat Wall Street’s estimates. The company also narrowed its earnings and revenue forecast for the year due to its $1 billion acquisition of biotech firm Peloton Therapeutics, announced in May.

In May, Merck said it had increased production of the measles vaccine to meet an uptick in demand in the U.S. in the midst of the country’s biggest outbreak in decades.

Merck earnings beat Wall Street’s expectations

The Centers for Disease Control and Prevention has reported 1,164 individual cases of measles as of July 25. The CDC said the new cases represented a 1.4% increase in the number of cases from the previous week. Officials had officially declared measles eliminated in 2000, but warned that if cases continued to climb this year the U.S. may lose its “eliminated” status.

Before the creation of the measles vaccine in the 1960s, the disease infected an estimated 3 million to 4 million people, hospitalized 48,000 and claimed the lives of between 400 and 500 people annually.

Measles started to spread again in recent years as more parents refused to vaccinate their children, even though health officials stress immunizations are the best way to protect against the measles. The World Health Organization reported a 300% increase in measles cases in the first three months of this year compared with the same time last year.

— CNBC’s Angelica LaVito contributed to this report.