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Saturday, February 20, 2021

AstraZeneca’s COVID-19 Vaccine Not Recommended for People Over 65 in Germany

 

AstraZeneca’s COVID-19 Vaccine Not Recommended for People Over 65 in Germany

Health officials in Germany have cautioned that the AstraZeneca/Oxford University COVID-19 vaccine (AZD1222) should not be given to people over the age of 65. Germany’s disease control agency, the Robert Koch Institute, only recommends the shot for people between the ages of 18-64 after concluding that there is not enough data available to determine whether the vaccine is effective in people aged 65 and older.1

According to the agency’s draft recommendation, only six percent of the COVD-19 vaccine trial participants were over the age of 65. Of those participants aged 65 and older, 347 received the vaccine

while 319 received the placebo. Germany’s health minister, Jens Spahn, stated, “It has been known since the autumn that fewer seniors were included in the trials supplied by AstraZeneca than the trials of other manufacturers.”2

There was one COVID-19 infection reported in the experimental vaccine group and one in the placebo group, which German health officials say is “no longer statistically significant” and “Any assessment about the efficacy of the vaccination among the highest age group (≥75 years) therefore comes with a high level of uncertainty.”3

Two German newspapers, Handelsblatt and the Bild, broke the story that the vaccine may not protect the most elderly vulnerable population. The Handelsblatt said that the efficacy rate for those over the age of 65 was only eight percent compared to an efficacy rate of 62 percent after two doses of the vaccine in the rest of the adult population. The paper asserted that this efficacy rate was determined by the internal calculations of a federal authority in the department of Ministry of Health.4

Vaccine Manufacturer Denies Low Efficacy Rate in Seniors

Both AstraZeneca and Oxford University denied the newspapers’ claims that the novel vaccine was not effective in the elderly population. A spokesperson for the Oxford University said, “There is no basis for the claims of very low efficacy of the AstraZeneca/Oxford University vaccine which have been circulating in the media.”5

The CEO of AstraZeneca, Pascal Soriot, also refuted the claim that the vaccine is only eight percent effective in the over 65 population. Soriot said:

What can I say? I don’t have any idea where this number is coming. It’s incorrect. Several regulators of many countries have approved this vaccine for people 18 years old and above. How can one think that all these people, all these regulators around the world would have approved our vaccine if its efficiency was eight percent? I mean, of course not… There is a lot of silly talk going on right now about all sorts of things. Some people making up stories, for what reason? I’m not sure. There may also be local political considerations sometimes?

Soriot admitted that there is limited date available for the over 65 population…

You have to think that the program we have today was run by Oxford, it was the Oxford program. And Oxford is an academy group. They´re very ethical, and very academic. So, they didn´t want to vaccinate older people until they had accumulated a lot of safety data in the 18 to 55 group.6

An AstraZeneca spokesperson stated:

In November, we published data in The Lancet demonstrating that older adults showed strong immune responses to the vaccine, with 100% of older adults generating spike-specific antibodies after the second dose.7

There has been controversy over how the claimed eight percent efficacy rate was derived. A spokesman for the German Health Ministry, who also denied that the efficacy rate was so low in the elderly population, suggested that the person who determined the eight percent rate must have mixed up the numbers…

At first glance, it appears that two things have been confused in the reports: About 8% of the subjects in the AstraZeneca efficacy study were between 56 and 69 years of age, and only 3 to 4% were over 70 years of age. “However, this does not infer an efficacy of only 8% in the elderly.8

However, Handelsbatt denied that there was any error with their reporting. Quoting a high-ranking official from Germany’s Federal Ministry of Health, the newspaper said, “It is impossible to mix up the numbers. According to the data we have so far, the effectiveness in people over 60 is less than ten percent.” One of the journalists who broke the story, Gregor Waschinski, argued that the numbers were confirmed by multiple sources familiar with the German vaccination policy”9

Oxford University maintained that peer to peer-reviewed publications showed that younger and older adults had similar immune responses.10 The German health ministry agreed that the claims of inferior efficacy of the AstraZeneca/Oxford University vaccine were not supported by data and cited a study in The Lancet, which showed that older adults generated antibodies following their second vaccine dose. The phase two study published in The Lancet in November 2020 showed that the 240 participants over the age of 70 had a similar immune response to those in the 18-56 age group. The phase 2 trials had limitations, however, as it did not test vaccine efficacy and all the elderly patients, who were an average age of 73-74, were white nonsmokers with few underlying health conditions.11

However, another article in The Lancet published on Dec. 8 examined the efficacy data for the AstraZeneca/Oxford University vaccine and found that the interim analysis could not determine efficacy in older adults due to insufficient data: less than four percent of the participants were older than 70 years of age.12

Concerned that these news reports would deter vaccine uptake, U.K. Prime Minister Boris Johnson’s official spokesperson said:

The important thing is to ensure the public remain confident that it is both safe and effective and continue to come forward to receive the vaccine when invited to do so. AstraZeneca said that its jab was approved in December without an upper age limit by Britain’s Joint Committee on Vaccination and Immunization.

European Union Charges AstraZeneca Violated COVID-19 Vaccine Supply Contract

The dispute over the efficacy of the vaccine in the elderly population is not the only controversy surrounding the AstraZeneca/Oxford vaccine in the European Union (E.U.). AstraZeneca has failed to perform its contractual obligation to supply the E.U. with 300 million doses of COVID-19 vaccine.

In August 2020, AstraZeneca was paid 409 million dollars to deliver 300 million doses of the new COVID-19 vaccine to E.U. countries. However, due to “reduced yields at a manufacturing site” in the EU supply chain, AstraZeneca is projecting it expects to fall 61 percent short of their contracted obligation and initially only deliver 31 million doses to the E.U.13

Despite all the controversy, 6.5 million people in the U.K. have already received at least one dose of a COVID-19 vaccine14 and there are plans to give 15 million more people their first dose of the vaccine by mid-February.15


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