"over 100,000 pregnant women have taken the vaccine...". ....... there's your phrase III trial cohort right there.
the CDC and WHO are constantly monitoring these groups of people subjects. the data base is now bigger than any comparable trial samples, including the short time frame involved.
yes its rushed but don't doubt the professionalism involved.
The (H1N1)pdm09 virus was very different from H1N1 viruses that were circulating at the time of the pandemic. Few young people had any existing immunity (as detected by antibody response) to the (H1N1)pdm09 virus, but nearly one-third of people over 60 years old had antibodies against this virus, likely from exposure to an older H1N1 virus earlier in their lives. Since the (H1N1)pdm09 virus was very different from circulating H1N1 viruses, vaccination with seasonal flu vaccines offered little cross-protection against (H1N1)pdm09 virus infection. While a monovalent (H1N1)pdm09 vaccine was produced, it was not available in large quantities until late November—after the peak of illness during the second wave had come and gone in the United States. From April 12, 2009 to April 10, 2010, CDC estimated there were 60.8 million cases (range: 43.3-89.3 million), 274,304 hospitalizations (range: 195,086-402,719), and 12,469 deaths (range: 8868-18,306) in the United States due to the (H1N1)pdm09 virus.https://www.cdc.gov/flu/pandemic-resources/2009-h1n1-pandemic.htmlhow many people died from your memory of H1N1? I don't recall hearing of any.... what country was this?
A review by theU.S. National Institutes of Health(NIH) concluded that the 2009 H1N1 ("swine flu") vaccine has a safety profile similar to that of seasonal vaccine.[11]
In an initial clinical trial in Australia, non-serious adverse events were reported by about half of the 240 people vaccinated, with these events including tenderness and pain at the site of injection, headache, malaise, and muscle pain.[66]Two people had more severe events, with a much longer spell of nausea, muscle pain and malaise that lasted several days. The authors stated that the frequency and severity of these adverse events were similar to those normally seen with seasonal influenza vaccines.[66]A second trial involved 2,200 people ranging from 3 to 77 years of age.[70]In this study no patients reported serious adverse events, with the most commonly observed events being pain at the injection site and fever, which occurred in 10–25% of people.[70]Although this trial followed up patients individually, the Government has been criticized for relying on voluntary reporting for post-vaccination evaluation in other circumstances, since this is "unlikely to accurately measure the percentage of people who get adverse effect".[12]
As of 19 November 2009, the World Health Organization (WHO) said that 65 million doses of vaccine had been administered and that it had a similar safety profile to the seasonal flu vaccine, with no significant differences in the adverse events produced by the different types of vaccine.[71]There has been one report of an adverse event per 10,000 doses of vaccine, with only five percent of these adverse events being serious, an overall rate of serious events of one in 200,000 doses.[71]
In Japan around 15 million people had been vaccinated by 31 December 2009. 1,900 cases of side effects and 104 cases of death were reported from medical institutions. The health ministry announced that it will conduct epidemiologic investigation.
https://en.wikipedia.org/wiki/2009_swine_flu_pandemic_vaccine
