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FDA advisory group recommends Moderna booster for emergency use

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FDA advisory group recommends Moderna booster for emergency use

Posted | Updated by Insights team:

Publication | Update:

Oct 2021
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A Food and Drug Administration advisory panel voted Thursday to recommend Moderna booster shots for emergency use authorization, bringing millions of people in the U.S. one step closer to being eligible for additional doses.

The panel, called the Vaccine and Related Biological Products Advisory Committee, voted unanimously in favor of authorizing the shots. The decision will go to the FDA, which is expected to make a final ruling in the coming days.

Full coverage of the Covid-19 pandemic

The panel’s recommendations followed the blueprint it established last month for booster shots of Pfizer-BioNTech’s vaccine: For people who were initially vaccinated with Moderna, the booster would be authorized for adults ages 65 and up, people in long-term care facilities and people ages 18-64 with underlying medical conditions and who are at high risk of exposure to the coronavirus because of their job. Such people would be eligible at least six months after their second shots.

Moderna’s booster dose would be given as a half-dose of 50 micrograms, compared to the 100 micrograms given in the initial vaccination series. (By contrast, Pfizer’s booster is the same 30-microgram dosage as its initial series.)

Jacqueline Miller, the therapeutic area head for infectious diseases at Moderna, said in her presentation to the committee that the company chose the half-dose because it wanted to use the lowest dose possible needed to induce an immune response. 

Miller noted that using a lower-dose booster has worked well for other vaccines, including the DTaP vaccine, which protects against tetanus, diphtheria and whooping cough.

The meeting was less contentious than the group’s discussion last month about Pfizer, when the advisers rejected authorizing Pfizer boosters for all adults 18 and up six months after their initial vaccinations and instead opted to limit eligibility.

In a discussion after the vote, the panel largely agreed that boosters were not yet needed for the broader population, which would include all adults 18 and up.

The younger population appears to be responding quite well to the vaccines, and protection is holding up, said Dr. Michael Kurilla, an infectious disease expert with the National Institutes of Health. "I don’t necessarily see the need for a sort of 'let it rip' campaign for boosters for everyone who’s ever been vaccinated."

The case for Moderna

Data shows that protection from Moderna’s vaccine has waned: People who were vaccinated earlier in the year were more likely to have breakthrough infections compared to people who were vaccinated several months later, Miller said. Nearly all of the breakthrough infections were caused by the delta variant. 

Several of the breakthrough cases were considered severe, and two people died. 

"We are concerned about the breakthrough disease that we’ve been observing" in the participants in the original clinical trial, Miller said, "and particularly the breakthrough cases that we’re starting to see in severe disease in the older adults."

The booster dose led to higher antibody levels, including antibodies against the delta variant.

Still, a handful of breakthrough infections — 20 cases — were reported among people who received boosters.

Dr. Doran Fink, a deputy director of the FDA’s division of vaccines, said it’s still unknown what levels of antibodies are needed for protection.

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Both Moderna’s presentation and the FDA’s analysis found the booster to be safe, although several committee members said they wanted to see more safety data from the company.

Side effects from the booster were similar to those seen after the second dose. They included arm pain, fatigue, headache and muscle aches.

However, the booster trial didn’t include enough participants to evaluate whether the extra dose raised the risk for myocarditis, Fink said. 

Myocarditis, or inflammation of the heart muscle, has been linked to both Moderna’s and Pfizer’s Covid-19 vaccines. The condition is rare and mostly commonly seen in men under 30. 

Hui-Lee Wong, the associate director for innovation in the FDA’s Office of Biostatistics and Epidemiology, said myocarditis occurred in similar rates following the second doses of both vaccines.

In data from Israel, where 3.7 million people have gotten Pfizer booster shots, 17 cases of myocarditis were reported, said Dr. Sharon Alroy-Preis, the director of public health services for Israel’s Health Ministry, who presented Thursday. 

"The rate of it is really, really low compared to what you would have expected, if it was the same rate as after the second dose," she said. "Perhaps it’s because we’re giving this dose five months or later" as opposed to giving two doses three weeks apart.

The same group of advisers will convene Friday to discuss a booster shot of Johnson & Johnson’s Covid vaccine. It will also review the results of a National Institutes of Health study of "mixing and matching" Covid vaccines. The study found that giving people who initially received the Johnson & Johnson vaccine booster doses of either Pfizer’s or Moderna’s vaccine led to a stronger immune response than a second Johnson & Johnson dose.

Next week, a group of advisers to the Centers for Disease Control and Prevention will take up the question of who should receive the Moderna and Johnson & Johnson booster shots. If the boosters are recommended, the CDC director, Dr. Rochelle Walensky, would then sign off, and shots could start going into arms.

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Forecast methodology

The future outlook “forecast” is based on a set of statistical methods such as regression analysis, industry specific drivers as well as analyst evaluations, as well as analysis of the trends that influence economic outcomes and business decision making.
The Global Economic Model is covering the political environment, the macroeconomic environment, market opportunities, policy towards free enterprise and competition, policy towards foreign investment, foreign trade and exchange controls, taxes, financing, the labour market and infrastructure. We aim update our market forecast to include the latest market developments and trends.

Forecasts, Data modelling and indicator normalisation

Review of independent forecasts for the main macroeconomic variables by the following organizations provide a holistic overview of the range of alternative opinions:

  • Cambridge Econometrics (CE)

  • The Centre for Economic and Business Research (CEBR)

  • Experian Economics (EE)

  • Oxford Economics (OE)

As a result, the reported forecasts derive from different forecasters and may not represent the view of any one forecaster over the whole of the forecast period. These projections provide an indication of what is, in our view most likely to happen, not what it will definitely happen.

Short- and medium-term forecasts are based on a “demand-side” forecasting framework, under the assumption that supply adjusts to meet demand either directly through changes in output or through the depletion of inventories.
Long-term projections rely on a supply-side framework, in which output is determined by the availability of labour and capital equipment and the growth in productivity.
Long-term growth prospects, are impacted by factors including the workforce capabilities, the openness of the economy to trade, the legal framework, fiscal policy, the degree of government regulation.

Direct contribution to GDP
The method for calculating the direct contribution of an industry to GDP, is to measure its ‘gross value added’ (GVA); that is, to calculate the difference between the industry’s total pre­tax revenue and its total bought­in costs (costs excluding wages and salaries).

Forecasts of GDP growth: GDP = CN+IN+GS+NEX

GDP growth estimates take into account:

  • Consumption, expressed as a function of income, wealth, prices and interest rates;

  • Investment as a function of the return on capital and changes in capacity utilization; Government spending as a function of intervention initiatives and state of the economy;

  • Net exports as a function of global economic conditions.

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Market Quantification
All relevant markets are quantified utilizing revenue figures for the forecast period. The Compound Annual Growth Rate (CAGR) within each segment is used to measure growth and to extrapolate data when figures are not publicly available.

Revenues

Our market segments reflect major categories and subcategories of the global market, followed by an analysis of statistical data covering national spending and international trade relations and patterns. Market values reflect revenues paid by the final customer / end user to vendors and service providers either directly or through distribution channels, excluding VAT. Local currencies are converted to USD using the yearly average exchange rates of local currencies to the USD for the respective year as provided by the IMF World Economic Outlook Database.

Industry Life Cycle Market Phase

Market phase is determined using factors in the Industry Life Cycle model. The adapted market phase definitions are as follows:

  • Nascent: New market need not yet determined; growth begins increasing toward end of cycle

  • Growth: Growth trajectory picks up; high growth rates

  • Mature: Typically fewer firms than growth phase, as dominant solutions continue to capture the majority of market share and market consolidation occurs, displaying lower growth rates that are typically on par with the general economy

  • Decline: Further market consolidation, rapidly declining growth rates

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The Global Economic Model
The Global Economic Model brings together macroeconomic and sectoral forecasts for quantifying the key relationships.

The model is a hybrid statistical model that uses macroeconomic variables and inter-industry linkages to forecast sectoral output. The model is used to forecast not just output, but prices, wages, employment and investment. The principal variables driving the industry model are the components of final demand, which directly or indirectly determine the demand facing each industry. However, other macroeconomic assumptions — in particular exchange rates, as well as world commodity prices — also enter into the equation, as well as other industry specific factors that have been or are expected to impact.

  • Vector Auto Regression (VAR) statistical models capturing the linear interdependencies among multiple time series, are best used for short-term forecasting, whereby shocks to demand will generate economic cycles that can be influenced by fiscal and monetary policy.

  • Dynamic-Stochastic Equilibrium (DSE) models replicate the behaviour of the economy by analyzing the interaction of economic variables, whereby output is determined by supply side factors, such as investment, demographics, labour participation and productivity.

  • Dynamic Econometric Error Correction (DEEC) modelling combines VAR and DSE models by estimating the speed at which a dependent variable returns to its equilibrium after a shock, as well as assessing the impact of a company, industry, new technology, regulation, or market change. DEEC modelling is best suited for forecasting.

Forecasts of GDP growth per capita based on these factors can then be combined with demographic projections to give forecasts for overall GDP growth.
Wherever possible, publicly available data from official sources are used for the latest available year. Qualitative indicators are normalised (on the basis of: Normalised x = (x - Min(x)) / (Max(x) - Min(x)) where Min(x) and Max(x) are, the lowest and highest values for any given indicator respectively) and then aggregated across categories to enable an overall comparison. The normalised value is then transformed into a positive number on a scale of 0 to 100. The weighting assigned to each indicator can be changed to reflect different assumptions about their relative importance.

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The principal explanatory variable in each industry’s output equation is the Total Demand variable, encompassing exogenous macroeconomic assumptions, consumer spending and investment, and intermediate demand for goods and services by sectors of the economy for use as inputs in the production of their own goods and services.

Elasticities
Elasticity measures the response of one economic variable to a change in another economic variable, whether the good or service is demanded as an input into a final product or whether it is the final product, and provides insight into the proportional impact of different economic actions and policy decisions.
Demand elasticities measure the change in the quantity demanded of a particular good or service as a result of changes to other economic variables, such as its own price, the price of competing or complementary goods and services, income levels, taxes.
Demand elasticities can be influenced by several factors. Each of these factors, along with the specific characteristics of the product, will interact to determine its overall responsiveness of demand to changes in prices and incomes.
The individual characteristics of a good or service will have an impact, but there are also a number of general factors that will typically affect the sensitivity of demand, such as the availability of substitutes, whereby the elasticity is typically higher the greater the number of available substitutes, as consumers can easily switch between different products.
The degree of necessity. Luxury products and habit forming ones, typically have a higher elasticity.
Proportion of the budget consumed by the item. Products that consume a large portion of the consumer’s budget tend to have greater elasticity.
Elasticities tend to be greater over the long run because consumers have more time to adjust their behaviour.
Finally, if the product or service is an input into a final product then the price elasticity will depend on the price elasticity of the final product, its cost share in the production costs, and the availability of substitutes for that good or service.

Prices
Prices are also forecast using an input-output framework. Input costs have two components; labour costs are driven by wages, while intermediate costs are computed as an input-output weighted aggregate of input sectors’ prices. Employment is a function of output and real sectoral wages, that are forecast as a function of whole economy growth in wages. Investment is forecast as a function of output and aggregate level business investment.

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