06Jun

With the approval last month of the Moderna vaccine by the Food and Drug Administration, we now have two COVID-19 vaccines available. Two more – one from Johnson & Johnson the other from AstraZeneca – are on the way and could be approved as soon as February.

Healthcare workers, residents of nursing facilities and some first responders have already received the Pfizer vaccine, the first one approved by the FDA. Moderna has begun shipping its vaccine with the first of the 25 million initial doses administered last month.

People eager to be immunized have inundated doctors’ offices and clinics asking when the vaccine will be available. The best answer is soon.

Which one, though, will you receive? And does it make any difference?

The answer to the first question is whichever vaccine can be obtained the quickest or, in some cases, whichever your health plan recommends. It really doesn’t make any difference to you.

Both vaccines require two separate doses to reach maximum effectiveness 21 days apart for Pfizer and 28 days for the Moderna version. Both protect about equally well. The FDA data shows Pfizer is 95% effective after both doses. Moderna is 94.1%.

Unlike most other vaccines, these two vaccines use pieces of protein from the SARS-CoV-2 virus to prompt the body to create antibodies. Conventional vaccines, like the annual flu shot, are manufactured from viruses typically grown in chicken eggs. These chicken grown viruses are then killed or weakened to become vaccines.

The COVID vaccines employ messenger RNA (mRNA), a newer technology. These vaccines “teach” the body to replicate the little bit of the CoV-2 protein, which, in turn, creates an immune response causing the body to make the antibodies that provide the protection against the virus.

The most significant difference between the Moderna and the Pfizer vaccines is how they must be stored. Both can survive for a few days in standard refrigeration. For longer periods, the less stable Pfizer vaccine must be kept in ultra-low temperatures below -94 F. That makes shipping and storing Pfizer’s vaccine somewhat more complicated, especially outside urban areas where the low temperature refrigeration is not easily available.

“At the end of the day, these two vaccines are pretty similar,” Dr. Thomas Russo, professor and chief of infectious disease at the State University of New York, tells Health. “Grab it while you can.”

Photo by Hakan Nural

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Jun 6, 2023

Pandemic Gives Drug Onshoring New Momentum

The shortage of masks, respirators and other medical supplies that accompanied the rise of COVID-19 cases has added momentum to government efforts to encourage the onshoring of medical manufacturing.

Since the beginning of the year, the US government through the Biomedical Advanced Research and Development Authority (BARDA) has awarded at least billion dollars to bioscience and contract development and manufacturing organizations to create or expand production capability in the US.

In May, four-month old drug manufacturer Phlow got a $354 million award from the federal government to manufacture generic medicines and pharmaceutical ingredients that are needed to treat Covid-19.

In June, Emergent BioSolutions announced a $628 million deal with the government to commit its Baltimore facility manufacturing capacity for production of COVID-19 vaccine candidates through 2021.

Last week, Grand River Aseptic Manufacturing, announced it had completed work on a $60 million privately financed expansion of its Michigan fill/finish facility. GRAM is a contract development and manufacturing firm that completes the final, sterile packaging of injectable drugs for companies that developed or market them.

These are just the latest examples of what FiercePharma describes as a “growing wave of manufacturers and drugmakers pitching their domestic footprint.”

While political interest in bringing drug manufacturing back to the US isn’t new, the current pandemic has given the effort greater momentum. A raft of legislation has been introduced in Congress from both sides of the aisle. FiercePharma says a bill by Arkansas Republican Sen. Tom Cotton “would require government payers to phase out reimbursement for drugs made or sourced in China by 2022. Other bills have also directly targeted China’s role in the supply chain as a possible national security issue.”

The White House said it is working on an executive order to require federal agencies to purchase only US made medical products and drugs.

Though the pharmaceutical industry is opposed to compelling all manufacturing to move to the US, the political winds, not to mention the incentives the government is dangling, is beginning to interest investors.

The real estate equities firm Lincoln Equities Group and H.I.G. Realty Partners, the real estate arm of private equity firm H.I.G. Capital, LLC, which owns the 422 acre former Bristol Myers Squibb lifesciences campus in New Jersey, is making a direct pitch to pharmaceutical manufacturing firms to locate there.

“Given the current public health crisis, we anticipate pharmaceutical and life sciences manufacturers to consider ‘reshoring’ and expanding operations in the U.S.,” said Joel Bergstein, president of Lincoln Equities. “This spacious, modern BMS campus – located in the center of ‘Einstein’s Alley’ in Central New Jersey – is a prime location for continued innovation and expansion.”

Image courtesy Grand River Aseptic Manufacturing

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